The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

SENIOR MANAGER - GOVERNMENT ACCOUNTABILITY - Novo Nordisk
Facility: Legal, Compliance and Audit
Location: Plainsboro, NJ, US


About the Department
At Novo Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ethical & privacy standards and ensuring adherence to corporate and legal regulations, this team is constantly called upon to design and implement creative solutions to complex issues. From training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, ECP keeps us accountable every step of the way as we develop life-changing therapies and bring them to market. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference?

The Position
The position is responsible for managing daily operational activities related to the Ethics & Compliance (E&C) Departments government reporting obligations including but not limited to Transparency Reporting (e.g. local, state, federal requirements for transfers of value, price reporting, disclosure requirements, sharp/drug takebacks), Novo Nordisk Inc (NNI) government agreements (e.g. Corporate Integrity Agreement (CIA)) regulatory requirements (e.g. PDMA reporting) and the systems that support these processes (e.g. TRAC).

Relationships
This position reports to the Director E&C Government Accountability, and Frequently interacts with other E&C functional areas (e.g. BPs, Education). Regularly interacts, and provides direction to, information technology, Commercial Effectiveness, Clinical Operations and Marketing Effectiveness. Collaborates with Legal for assumptions and opinions. Manages external customers including Health Care Professionals (HCP), third party/external vendors, and external consultants. Interacts with government officials. Provides direction to NNIs Global Servicing Center in Bangalore. Supports North America and serves on global projects. Serves on technical and other subcommittees (e.g. CAB).

Essential Functions

  • Supports the Director - E&C Government Accountability in facilitating and raising awareness while fostering accountability for Ethics & Compliance program throughout the organization
  • Maintains understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical ethics & compliance and proposes updates to Ethics & Compliance program, as appropriate
  • Informs management of ethics & compliance issues in a timely manner while encouraging the flow of information between colleagues and lines of business. Actively works to identify, analyze, and mitigate potential business ethics and other risks to the organization
  • Manages the review and timely reporting of all government requirements while understanding local and global impact
  • Government Accountability
    • Supports the Director in the development of the annual plan to meet NNIs government obligations including but not limited to local, state and federal transparency requirements, sharp/drug takeback requirements, price reporting disclosures, PDMA requirements and any NNI specific government agreements
    • Manages creation and continued maintenance of government reporting protocols and assumption documents to support accurate filings and internal documentation
    • Responsible for supporting government attestations and the transactional and systems work that supports these attestations (e.g. data review)
    • Forwards risks and issues to appropriate E&C and line of business (LoB) teams in a timely manner
    • Creates comprehensive mitigation and remediation plans in conjunction with E&C risk team to ensure correct strategies are in place to continually improve processes and data integrity
    • Supports NN affiliates (e.g., NNCI) with implementing and maintaining a government accountability program
    • Responsible for creating and executing an Organizational Change Management (OCM) Plan for Government Accountability Programs, as needed
    • Conducts training to employees and third party vendors to timely communicate new government reporting requirements or updated NNI interpretations
    • Supports the government accountability budget (e.g. forecasting expenditures, reporting variances, and ensuring responsible spending)
    • Responsible for ensuring that Compliance senior management is informed of compliance issues in a timely manner and encourages the flow of information between Compliance colleagues and lines of business
    • Additional responsibilities with government reporting or departmental operational impact as assigned

      Systems Support
    • Supports Director with NN A/S collaborations regarding government reporting requirements and integration of systems/data
    • Point of contact for systems updates, upgrades and recommendations from LoB
    • Recommends enhancements to systems, processes and technologies for government reporting
    • Represents E&C on Change Advisory Boards and/or other systems boards as requested
 

Physical Requirements

  • 0-10% overnight travel required.
 

Qualifications

  • A Bachelor's degree from an accredited institution required
  • A minimum of 8 years combined pharmaceutical, legal, regulatory, and compliance experience required OR a minimum of 6 years  experience required if accompanied by an advanced degree or certificate (MBA, JD, PMP, etc.)
  • Demonstrates functional knowledge and understanding of the Anti-kickback Statute, the False Claims Act, Food & Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, government corporate integrity agreements, PhRMA and federal and state aggregate spend reporting requirements
  • Experience working under a government agreement is required (e.g. CIA, DPA, Consent Decree)
  • Demonstrates strong interpersonal skills and ability to influence at all levels of the organization
  • Excellent communication and organization skills
  • Excellent project management skills to oversee and drive project execution
  • Ability to manage multiple projects concurrently and collaborate across several functional areas
  • The ability to think objectively and use sound reasoning principles
  • Knowledge and experience with pharmaceutical aggregate spend solutions and data associated with promotional and clinical data, preferred
  • Ability to manage multiple projects to completion meeting internal and external deliverables with high degree of accuracy
  • Excellent communication skills (written and verbal), strong report writing skills and organization skills are required
  • Supervisory experience preferred
 

Millions rely on us
At Novo Nordisk, we don't wait for change. We drive change. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it's a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we're life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

 Apply here
Posted 6/21/2021

DIRECTOR, PHARMACEUTICALS COUNSEL - Oyster Point
Location: This role has the potential to be based in Boston, MA or Princeton, NJ US.


Overview:
The lawyer will be involved in all aspects of the U.S. commercial, medical, and market access organizations for the expected launch of the Company's lead investigational therapy and operate as part of a legal department focused on providing high quality and pragmatic legal service to internal clients.

Responsibilities:

  • Responsible for advising clients in, and reviewing materials for, the US marketing and sales organizations to support the expected launch of the Company's lead investigational therapy. Areas for advice and counsel include disease awareness campaigns, patient support programs, promotional campaigns, digital tools, and patient education. In advising on these issues, the lawyer will consider all relevant legal risks, including risks relating to FDA and other regulations governing the pharmaceutical industry, advertising, marketing, including anti-kickback and bribery issues, antitrust, regulatory policy, IP, copywrite, and contracts.
  • Responsible for counseling clients and supporting the build and implementation of process and tools for the Medical organization on a broad array of issues including but not limited to scientific exchange, publications, IITs, and other medical information communication.
  • Responsible for counseling market access clients with respect to interactions with payers, including relevant access programs, payer materials and payer contracting. Advise regarding risk regarding drug pricing, rebates, and market access objectives. Set appropriate mitigation strategies as warranted. Provide guidance and work collaboratively with internal business clients on policies and procedures to ensure compliance with statutory and regulatory drug price reporting obligations, including Medicaid, Medicare and other government programs.
  • Provide guidance to company regarding developments in federal and state laws and relevant litigation relating to price reporting and relevant contracting.
  • Provide guidance to company's commercial organization when interacting and/or contracting with pharmacies, healthcare professionals, commercial, state and federal payers, managed care organizations and pharmacy benefit managers.
  • Provide legal support for a range of activities associated with implementing patient assistance and support programs.
  • Support company product launch initiatives.
  • Will work on cross functional business teams, and also work with other lawyers in the legal department to provide comprehensive advice to clients.
Qualifications:

  • J.D. from an accredited law school, admission to and current good standing with the bar of at least one state or the District of Columbia, and ability to obtain in-house license for NJ and/or MA, as appropriate.
  • 5-7 years of legal experience, either within the pharmaceutical or biotechnology industry or a law firm that advises companies in the pharmaceutical or biotechnology industries on their advertising, marketing, promotional, market access strategies and activities. In-house experience strongly preferred.
  • Experience in Food & Drug Regulations, the Anti-Kickback Law, FCA, healthcare compliance law and ad promotion is strongly preferred.
  • Experience in, or familiarity with prescription drug distribution channel(s) and contracting with the various parties in this channel, how managed care organizations are structured and their role in the prescription drug channel and the rules and regulations concerning healthcare programs (including Medicare, Medicaid, and the Veterans Administration), US Health Care Fraud and Abuse Laws, as well as general commercial contracts is strongly preferred.
  • Experience with Privacy Laws is preferred.
  • Experience advising clients developing advertising and promotion using innovative technical platforms (including social media) is preferred.
  • Experience working with clients in biotech, healthcare or other regulated industries is strongly preferred.
  • Candidate must also have excellent interpersonal skills, excellent oral and written communication skills, ability to work with cross-functional teams and build consensus among various stakeholders while maintaining a compliant approach, ability to present to senior leadership, and the ability to work well both independently and as part of a team. Candidate must be willing to work on an array of matters across the company.
  • Candidate must be able to demonstrate a history of successfully resolving challenging legal issues and ability to effectively deliver sound and clear legal advice in a business setting.
  • Successful candidate must have excellent judgment and the knowledge and ability to involve others who may possess the needed expertise to address issues as required.
  • Ability to travel as needed.
  • This role is a Director level role.
  • This role has the potential to be based in Boston, MA or Princeton, NJ.
 Apply here
Posted 5/25/2021

DIRECTOR, U.S. COMPLIANCE & ETHICS - Oyster Point
Location: Headquartered in Princeton, New Jersey, with an anticipated satellite office in Boston US


Summary:
Oyster Point Pharma, Inc. (OYST: Nasdaq) is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases. Headquartered in Princeton, New Jersey, with an anticipated satellite office in Boston, Oyster Point filed its first New Drug Application in Q4' 2020 and an anticipated product launch in Q4' 2021. This is an exciting time to join Oyster Point as it prepares to transition from a clinical stage company to commercial enterprise, and we seek a skilled senior compliance leader who has the drive to be part of this transformation and the experience to design and build a compliance program that supports Oyster Point's next phase.

Reporting to the Vice President, U.S. Compliance, Ethics and Risk Management, the Director, U.S. Compliance & Ethics will be a key member supporting Oyster Point's anticipated rapid growth and shaping the company's culture to enable achievement of the company's goals and objectives in a compliant and ethical manner. This role work collaboratively across the business supporting and advising colleagues on Oyster Point's compliance and ethics program.

The Director, U.S. Compliance & Ethics will assist with the designing, building, implementing and maintaining an effective healthcare compliance program including building a culture of compliance into the fabric of the organization, at all levels and in all departments.

Primary Responsibilities: Responsibilities include, but are not limited to, the following:

  • Assist with the designing, building, implementation and maintenance of a robust and effective healthcare and corporate compliance program that is right-sized for Oyster Point as it transitions to a commercial organization
  • Actively engage with business partners to understand and provide proactive compliance guidance on the development and execution of proposed strategic and tactical initiatives
  • Provide leadership and guidance on business programs, identify complex compliance issues, analyze alternatives and work with business partners to develop and implement solutions
  • Work collaboratively across the business to develop, update, and implement compliance policies and procedures that are right-sized for Oyster Point and reflective of existing and updates to applicable laws, regulations guidance, codes, and policies
  • Develop and deliver engaging communications, trainings, and other content to help employees understand and be accountable for their role in building a compliant and ethical organization
  • Prepare and execute monitoring plans and other oversight programs for key areas of risk
  • Foster a strong internal compliance, ethics, and speak-up culture by creating an environment in which employees see Compliance as a strategic partner
  • Assist with conducting investigations into allegations of violations of applicable laws, regulations or policies and recommend corrective action where appropriate
  • Develop process for and oversee compliance with applicable state and federal laws and regulations that require reporting of product prices, interactions with healthcare providers (e.g., Physician Payments Sunshine Act), sampling and other activities
  • Support Privacy initiatives for federal and state privacy law compliance (e.g., GDPR, CCPA, CPRA, VCDPA)
  • Participate in internal risk management initiatives such as CME grant, IIT grant and sponsorship reviews
  • Participate in Oyster Point's Fair Market Value initiatives
  • Manage and coordinate with vendors, third parties and others to support the development, implementation, and maintenance of the compliance program
  • Operate independently with autonomy and limited supervision
  • Other responsibilities in support of the Compliance team, functional, and/or corporate strategies and goals

Required Skills:

  • A minimum of 7 years of relevant experience in both developing (e.g., materials, system identification) and assisting with the implementation of healthcare and corporate compliance programs in the pharmaceutical/biotech industry
  • A successful track record helping to build a culture of compliance and ethics in which compliance and business objectives are mutually reinforcing and establishing effective reporting, monitoring, and auditing programs
  • In-depth understanding of the pharmaceutical industry with expertise in the body of laws, regulations, guidance, and codes impacting pharmaceutical companies
  • In-depth knowledge of commercial, compliance and regulatory matters related to the launch and subsequent commercialization of branded pharmaceutical products

Other Requirements:

  • A high sense of ethics and integrity with an approachable and pragmatic style to communication and application
  • Demonstrated ability and prioritization to be a valued business partner
  • Desire and ability to both develop strategy and to implement timely, with hands-on creation and delivery of materials and process
  • Entrepreneurial spirit and enterprise-ownership mindset
  • Ability to manage projects internally and with external vendors and see through projects to completion within established deadlines
  • Willingness and desire to be a leader and a contributor and operate outside a box or precise scope of a role
  • Demonstrated leadership and strong communications skills, business acumen, and ability to make decisions efficiently
  • Exceptional interpersonal, written, and verbal communications skills, including the ability to communicate complex issues and concepts and influence across a cross-functional organization; ability to flex styles of communication
  • Strong problem-solving and decision-making skills with demonstrated ability to think creatively and devise solutions to challenging problems
  • Strong sense of accountability and ownership; proactive and self-motivated
  • Highly collaborative; ability to work independently and as a teammate
  • Ability and desire to lead, influence and collaborate cross-functionally
  • Positive, growth mindset
  • Thrive in a fast-paced, lean, highly dynamic environment
  • Ability to travel
 Apply here
Posted 5/25/2021

MANAGER, COMPLIANCE OPERATIONS - Amryt Pharma
Location: Boston, MA US


We are seeking an experienced compliance professional to support the operations of our Global Compliance team. This person must be knowledgeable of healthcare compliance requirements, particularly U.S. laws and regulations, OIG guidance, transparency requirements, and applicable industry codes. Experience in the design, enhancement and implementation of processes and controls to support compliance operations of a growing biotech company is a strong plus.

Position Description
This individual will report directly to the Executive Director, Compliance and will support the day-to-day operations of our global compliance program. This will include (but is not limited to): developing policies, managing training, implementing compliance and Corporate Integrity Agreement ("CIA") requirements, working with compliance vendors, and assisting with auditing & monitoring. This person will be responsible managing the processes and controls required for compliance with various national laws and regulations and industry best practices.

This individual will be a key business liaison to all business functions on compliance operational issues. In this respect, the individual must have good communication skills, emotional intelligence, business acumen, and sound judgment to efficient support our compliance requirements and advance our processes.

Key Responsibilities

  • Report to the Executive Director, Compliance and serve as the principal resource for compliance operations for employees globally.
  • Assist with developing, updating and implementing global compliance policies and standard operating procedures and ensure consistency across business units.
  • Assist with managing global transparency reporting including the timely and accurate data submissions for Open Payments, state disclosure law reports, and global requirements as needed.
  • Assist with the design and execution of compliance auditing and monitoring program.
  • Assist in designing and implementing effective and efficient communication tools.
  • Maintain and manage employee, third-party vendor, and new hire compliance training.
  • Assist with managing compliance budget and compliance consultant arrangements.
  • Stay abreast of industry law changes and inform the business.

Qualifications and Experience

  • At least 3 years of experience in providing compliance advice to pharmaceutical/biotech companies, or in a similar role at a pharmaceutical/biotech company.
  • Experience operationalizing a Corporatize Integrity Agreement or similar agreement is a strong plus.
  • Pharmaceutical or biotech in-house experience is strongly preferred.
  • JD not required, but preferred.
  • Excellent interpersonal, communication, problem solving and analytical skills.
  • Exceedingly detail oriented and organized.
  • Demonstrated ability to work independently and experience prioritizing conflicting demands from multiple business units in a fast-paced environment.
  • Flexible and solution-oriented.
  • Based in or around Boston, or adjacent region.
  • Minimal to no travel required, once corporate travel resumes.

Interested candidates can send their CVs to: Vandella Hill at vandella.hill@amrytpharma.com.

Posted 5/24/2021

DIRECTOR, US COMPLIANCE - Moderna
Location: Cambridge, MA US
Reports to: Senior Director, Corporate Compliance


The Role:
The Director, US Compliance, will partner with the US Commercial and Medical Affairs teams responsible for communicating information on Moderna's marketed products to ensure activities are completed in compliance with company policy and procedure while achieving or exceeding business goals. The role will provide advice to the US Commercial and Medical Affairs teams across the brand planning, scientific engagement, training, and execution of their business processes, and will implement processes and systems to support the US market. Additionally, the role will ensure alignment between US business needs and the corporate compliance program by prioritizing requests and leveraging the global compliance infrastructure.

Here's What You'll Do:

  • Support the development and execution of US Commercial and Medical Affairs brand, scientific, and business plans.
  • Advise US Commercial and Medical Affairs staff on corporate compliance concerns related to their business processes.
  • Develop a US compliance strategy leveraging global compliance capabilities to meet the needs of a digitally-focused commercial strategy
  • Leverage your experience with virtual and digital events to support compliant, value-added activities
  • Implement processes to address US risks, leveraging global compliance capabilities when possible and innovating new solutions as needed.
  • Actively encourage the use of global compliance capabilities by identifying and prioritizing US business needs as part of the overall compliance program.
  • Provide support to Global Commercial Operations to ensure US sales training, including in-person training at POAs, is aligned with compliance priorities and dedicates sufficient focus to cover important compliance topics.
  • Communicate results of compliance monitoring and identified risks to US Commercial and US Medical Affairs functions; proposes mitigation and remediation plans and ensures sufficient resources are dedicated to properly execute them.
  • Leverage our Values Basecamp - Integrity, Quality, Respect - to build a strong culture of compliance.
  • Lead or support other critical initiatives as required.
  • Mitigate risk through reinforcing established procedures, spotting and escalating issues to Compliance leadership, and modeling business integrity and ethical behavior.

Here's What You'll Bring to the Table:

  • BA/BS in a field related to compliance or risk management.
  • 7-10+ years of diversified biotech/pharmaceutical industry experience, including a minimum of 3 years of experience in US compliance roles. Prior experience with supporting both commercial and medical affairs teams is required.
  • Demonstrated willingness to roll up sleeves to and do the work is required - this is an active role with a need to directly deliver.
  • Proven experience in balancing country-level operational priorities with global compliance program development imperatives to ensure continuous improvement across multiple functions in a global company.
  • Ability to interact collaboratively, yet objectively with all levels of management.
  • Ability to prioritize and direct efforts to the most critical areas and issues; build solid, collaborative working relationships across multiple functions; and drive improvement initiatives with a sense of urgency.
  • Working knowledge of major business processes and compliance/risk issues related to the bio-pharmaceutical industry in the United States.
  • Solid knowledge of compliance program frameworks and a passion to continuously improve.

Here's What We'll Bring to the Table:

  • Daily on-site catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

Why join Moderna
At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com.

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

#LI-XX1 (to be completed by TA Ops)

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.


 Apply here
Posted 5/20/2021

DIRECTOR, COMPLIANCE MONITORING, AUDITING, AND INVESTIGATIONS - Moderna
Location: Cambridge, MA US
Reports to: Senior Director, Corporate Compliance


The Role:
The Director, Compliance Monitoring, Auditing, and Investigations will be responsible for helping to build and overseeing the framework, processes, tools and resources needed to support Moderna's compliance monitoring, auditing, and investigations capabilities, with a mandate to leverage automation and technology to deliver meaningful operational improvements. The role will further implement and then ensure the effective operation of our compliance monitoring capabilities, including scheduling and conducting audits and investigations as required.

Here's What You'll Do:

  • Design and implement a comprehensive compliance monitoring program, including a 3-year plan to expand our monitoring capabilities.
  • Continue developing our third-party due diligence program, integrating it with compliance audits and our monitoring program.
  • Improve our investigative capabilities in partnership with Legal, Human Resources, and Corporate Security to include enhanced hotline and investigation support tools, aligned processes and investigation procedures.
  • Ensure the compliance monitoring and audit functions seamlessly flow into Integrated Risk Management to inform company risk management decisions.
  • Collaborate with Internal Audit and other functions to eliminate duplication of effort and maximize audit reliance.
  • Automate monitoring and consistently seek to add business value with our monitoring capabilities.
  • Actively conduct monitoring, audits, and investigations as needed.
  • Support and actively contribute to other corporate compliance initiatives to ensure seamless integration across the compliance program.
  • Leverage our Values Basecamp - Integrity, Quality, Respect - to build a strong culture of compliance.
  • Lead or support other critical initiatives as required.
  • Mitigate risk through reinforcing established procedures, spotting and escalating issues to Compliance leadership, and modeling business integrity and ethical behavior.

Here's What You'll Bring to the Table:

  • BA/BS in a field related to compliance, risk management, or audit.
  • 7-10+ years of diversified biotech/pharmaceutical industry experience, including a minimum of 5 years of experience in compliance monitoring or audit. Prior experience with corporate investigations is a major plus.
  • Demonstrated willingness to roll up sleeves to and do the work vs. manage, while building out the functional capabilities.
  • Proven experience in aligning monitoring, auditing, and investigative processes to ensure continuous improvement across multiple functions in a global company.
  • Ability to interact collaboratively, yet objectively with all levels of management.
  • Ability to prioritize and direct limited resources to the most critical areas and issues; build solid, collaborative working relationships across multiple functions; and drive improvement initiatives with a sense of urgency.
  • Working knowledge of major business processes and compliance/risk issues related to the bio-pharmaceutical industry.
  • Solid knowledge of compliance program frameworks and a passion to continuously improve.

Here's What We'll Bring to the Table:

  • Daily on-site catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

Why join Moderna
At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com.

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

#LI-XX1 (to be completed by TA Ops)

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.


 Apply here
Posted 5/20/2021

DIRECTOR, CORPORATE PROCEDURAL DOCUMENTS - Moderna
Location: Cambridge, MA US
Reports to: Senior Director, Corporate Compliance


The Role:
The Director, Corporate Procedural Documents will be responsible for helping to build and overseeing the framework, processes, tools and resources needed to support Moderna's corporate procedural documents, with a mandate to leverage automation and technology to deliver meaningful operational improvements. The role will further implement and then ensure the effective operation of our corporate procedural document framework, including operational support for Corporate Compliance and other Moderna departments.

Here's What You'll Do:

  • Identify needs and expectations for the corporate procedural document lifecycle by partnering with Moderna departments that rely on the corporate procedural document framework.
  • Continue developing our procedural document framework, both by improving the process and systems used to review, approve, and publish corporate policies, and supporting the development and revision of Corporate policies.
  • Establish a service to support corporate procedural documents that meets the expectations of Moderna departments while safeguarding the resources needed to maintain an effective compliance program, under the direction of Risk & Compliance leadership.
  • Enhance the process to assign training for corporate procedural documents, in collaboration with the Director, Compliance Operations, to ensure a seamless integration between procedural document and learning processes.
  • Improve the automation of training assignment for corporate procedural documents.
  • Support and actively contribute to other corporate compliance initiatives to ensure seamless integration across the compliance program.
  • Leverage our Values Basecamp - Integrity, Quality, Respect - to build a strong culture of compliance.
  • Lead or support other critical initiatives as required.
  • Mitigate risk through reinforcing established procedures, spotting and escalating issues to Compliance leadership, and modeling business integrity and ethical behavior.

Here's What You'll Bring to the Table:

  • BA/BS in a field related to compliance, risk management, or quality management. This is not a GxP position.
  • Masters or other relevant advanced degree preferred.
  • 7-10+ years of diversified biotech/pharmaceutical industry experience, including a minimum of 5 years of experience in procedural document management.
  • Demonstrated willingness to roll up sleeves to and do the work vs. manage, while building out the functional capabilities.
  • Proven experience in aligning corporate and quality procedural document management processes.
  • Ability to interact collaboratively, yet objectively with all levels of management.
  • Ability to prioritize and direct limited resources to the most critical areas and issues; build solid, collaborative working relationships across multiple functions; and drive improvement initiatives with a sense of urgency.
  • Working knowledge of major business processes and compliance/risk issues related to the bio-pharmaceutical industry.
  • Solid knowledge of compliance program frameworks and a passion to continuously improve.

Here's What We'll Bring to the Table:

  • Daily on-site catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

Why join Moderna
At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com.

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

#LI-XX1 (to be completed by TA Ops)

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.


 Apply here
Posted 5/20/2021

DIRECTOR, COMPLIANCE OPERATIONS - Boehringer Ingelheim
Location: Ridgefield, CT US
Relocation assistance is available


Description:
Accountable for leading the U.S.-wide Compliance Operations' key functions and personnel overseeing: Transparency & Disclosure (T&D), Government Reporting; Anti-Bribery Anti-Corruption (ABAC) program; Third-Party Due Diligence; FMV evaluations; the BI Global 'Center of Excellence' for cross-border spend reporting; Compliance Systems Validations; Compliance Analytics; Compliance Data Quality Center; and serves as the U.S. Healthcare Compliance (HCC) Officer. Responsible for the validation of all Compliance Operations' reporting tools and interfaces. Leads a team of Compliance professionals responsible for developing, implementing and maintaining effective Compliance Program elements for ABAC, FMV, T&D, Government Reporting, Training, Due Diligence, Analytics, etc., that is data-led and risk-based. Works collaboratively and supports all other Compliance functions, serves as Compliance Business Partner to HP Operations, and advises Corporate Compliance Operations.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities:

  • Accountable for the overall strategy, governance and execution of the U.S. Transparency & Disclosure (T&D) Program, including without limitation, the timely and accurate submissions of all U.S. entities' Federal, State, local and cross-border reporting requirements and certifications. Tracks updates for reporting requirements and new laws; designs and implements T&D strategy for complying with all legal requirements for spend capture and disclosure. Develops, implements, monitors and ensures validation of local and cross-border Disclosure Program and systems,  and reviews, approves and serves as escalation point for cross-border spend. Drafts and maintains policies and procedures. Influences and advises Corporate on global T&D Program. As the U.S. Healthcare Compliance Officer, responsible for localizing all Corporate Compliance Healthcare policies, programs or directives, as well as overseeing (including reviewing, approving and maintaining a database for) all (global) cross-border engagements with U.S. HCPs, HCOs, Patients and Patient Organizations. Reports quarterly on KPIs, trends and risks to U.S. Board, U.S. Compliance Committee and BIPI Compliance Advisory Committee. Prepares and oversees annual HHS/CMS certifications for VP, Chief Ethics & Compliance Officer.
  • Directs and oversees U.S.-wide Fair Market Value (FMV) program, including without limitation, the evaluation of HCPs, others as applicable and services provided to customer organizations, monitoring and assessment of engagement process, the annual bolus screening of HCPs, and periodic updates of the FMV rate-card data. Serves as escalation point and decision-maker for re-evaluations.
  • Accountable for strategy, execution and continuous evolution U.S.-wide Anti-bribery/Anti-corruption (ABAC) program, including without limitation, implementation of controls for FCPA and other global anti-corruption regulations, third-party due diligence and screening program, Compliance training, auditing and data analytics (including oversight of an off-shore data quality-control and analytics group).
  • Designs, implements and routinely enhances analytics functionality for Compliance Operations.
  • Lead (recruit, hire, coach, develop, motivate, manage and monitor performance) and directly manage a staff of approximately 4-6 dedicated Compliance professionals; Creates and maintains a performance-based team culture with clear accountability and a sense of accountability for achieving results. Management includes goal setting, performance evaluations and compensation decisions, hiring, and coordinating with stakeholders on the performance and expectations of the groups.

Requirements:

  • Bachelors degree from an accredited institution.
  • Masters degree (e.g. MBA, MSc) in Business Administration and/or Doctoral degree (e.g. PhD or LLM) in Law preferred.
  • Industry certification (e.g. HCCA or SCCE) also preferred.
  • History of successful performance in pharmaceutical Compliance leadership role(s).
  • At least 8 - 15 years of experience in Compliance Operations functions, e.g., T&D, ABAC, FMV, process- and system implementation for government reporting, data-capture and spend-reporting systems;
  • Knowledge and demonstrated experience in data analytics, CRM systems and aggregate reporting systems.
  • Pragmatic experience and functional knowledge of data analytics.
  • Demonstrated experience leading teams / managing groups (with strong preference for experience of managing groups or projects of significant risk, scale or complexity).
  • Substantial business, legal and regulatory knowledge and experience in pharmaceutical industry, including AKS, FCA, Fraud & Abuse laws, FCPA, PhRMA Code, etc.
  • Strong interpersonal, management and influencing skills and experience;
  • Strong results-orientation.
  • Proven ability to lead and influence outside scope of authority.
  • Must possess sound professional judgment, the ability to timely take "smart risks" based upon incomplete information, and serve as a "player/coach" in personally helping to ensure all responsibilities within Compliance Operations are timely achieved.

Eligibility Requirements:

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required).
  • Must be 18 years of age or older.

Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Candidates need to use the following link to apply for the role:
 Job Description - Director, Compliance Operations (211291) (taleo.net)

Posted 5/7/2021

DIR., ETHICS & COMPLIANCE - Purdue Pharma L.P.
Department: Ethics & Compliance
Location: Stamford, CT US
Position Reports to: VP, Chief Compliance Officer


Job Summary
Serve as a leader in the ethics and compliance program for Purdue and its subsidiaries, with primary responsibility for auditing and monitoring, continuously improving compliance reporting systems, and, directing the Company's Enterprise Risk Management (ERM) process. Responsible for leadership of ethics and compliance activities within portions of Commercial, Medical, Technical Operations, and R&D business areas, providing advice to allow individuals in these areas to operate within full compliance of laws, regulations, and guidance. Provide strategic direction and partnership to the business, advising on risk and assessing initiatives for full compliance and integrity.

Primary Responsibilities

  • Serve as a business partner, providing ethics and compliance guidance to various business units including but not limited to Commercial, Medical, Technical Operations, and R&D.
  • Direct and improve the Company's Enterprise Risk Management function.
  • Develop and execute an annual Monitoring Plan and provide input on/conduct related audits. Conduct and/or collaborate on audits and assessments and establish and oversee monitoring systems within the ambit of the Purdue ethics and compliance program. Analyze and present findings of same.
  • Direct Purdue's Fair Market Value (FMV) process.
  • Develop Standard Operating Procedures (SOPs) and Working Practices Documents (WPDs), as needed, both for Ethics & Compliance Department and other functions, and assist in implementation of training programs related to same. Monitor internal compliance with relevant SOPs and/or WPDs.
  • Serve as subject matter expert on privacy matters.
  • Conduct investigations, as needed.
  • Conduct compliance-related diligence activities for product/company development activity, as needed.
  • Participate in industry ethics and compliance and other leadership roles for benchmarking and professional development.
  • Oversee staff participating in above-outlined functions.
  • Stay current on ethics and compliance issues/hot topics, as well as industry trends, best practices, federal and state guidances, etc.

Education and Experience Requirements

  • Bachelor's Degree required. Advanced degree a plus.
  • At least 10 years relevant compliance, legal, or other relevant experience, with a minimum of four years of pharmaceutical or healthcare legal or compliance experience required; relevant advanced degrees are desirable and may count toward experience.
  • Demonstrated leadership skills, together with experience supervising others, as well as interacting with all levels of management.

Necessary Knowledge, Skills, and Abilities

  • Able to gain the confidence and trust of others through integrity, honesty and authenticity
  • Builds partnerships and works collaboratively with diverse teams to meet shared objectives
  • Excellent written and verbal communication skills; ability to convey information effectively to a wide range of audiences; comfortable with public speaking and presentations
  • Strong leadership and interpersonal skills; ability to collaborate with senior management, leadership, employees, government officials and external audiences to develop and maintain good working relationships
  • Consistently achieves results even under difficult circumstances

Supervisory Responsibilities (if Applicable)
N/A
 Apply here
Posted 5/5/2021

ASSOCIATE DIRECTOR, COMPLIANCE BUSINESS PARTNER I - RESEARCH, DEVELOPMENT & MEDICINE - Boehringer Ingelheim
Location: Ridgefield, CT US
Relocation assistance is available


Description:
This role will provide medical compliance business partner support for multiple specialty care therapeutic areas, multiple medical departments (including, but not limited to, Clinical Operations and Pharmacovigilance) and help facilitate BI's policies and procedure process. To assist in the development, implementation, and continuous improvement of an effective compliance program for all business activities within Research, Development & Medicine (RD&M). To support the risk assessment and analysis process to continuously evaluate risk areas and priorities to guide new Compliance efforts. To act as a business partner to RD&M Departments to provide assistance and advice on daily operations and ensure appropriate compliance controls and training, as well as investigations of non-compliant activity and corrective action for identified business activities. To work closely with other teams within the Ethics and Compliance Department to ensure consistent application and implementation of identified compliance controls, training, monitoring, and auditing.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities:

  • Participates in strategic planning for applicable organizational activities with the goal of providing compliance expertise and advice to ensure planning is efficient and considers compliance issues up-front. Also provides day-to-day support, advice and problem-solving expertise to applicable businesses to ensure business operations are conducted in full compliance with all relevant policies and procedures. Develops resources for applicable business areas, as needed, to help meet their respective compliance business needs. Monitors the external environment and recommends improvements to the company's compliance program based on identified industry best practices.
  • Provides compliance expertise and guidance to RD&M business partners to enable decision-making that stays within ethical boundaries while still optimizing business performance. Acts as a liaison with BI GmbH business and compliance colleagues to influence the conduct of global activities that implicate US laws and regulations.
  • Assesses training needs for business groups, provides input into training plans, and collaborates with appropriate individuals to develop training content, acting as subject matter expert for business area. Facilitates and delivers training as appropriate. Educates business groups in a way that closes knowledge gaps and addresses larger trends.
  • Collaborates with personnel responsible for auditing plans to execute the auditing plan, including developing and executing action plans for identified CAPAs (Corrective and Preventative Actions) and monitoring established controls after implementation. Analyzes auditing results to recommend improvements in Compliance or business operations. Supports other activities of RD&M, including risk assessment and strategic planning, training and communication, health care provider interaction initiatives (i.e., implementation of fair market value, Sunshine Act requirements), and development of ethical business culture.
  • Collaborate with internal OEC team members to identify areas of compliance risk in respective business areas, including but not limited to topics of Transparency & Disclosure, CIA, Anti-Bribery and Anti-Corruption (ABAC), and compliance operations, and ensure that systems, policies, procedures, training and other resources are coordinated to mitigate risk to impacted business areas. Effectively communicate and collaborate with OEC team members to ensure business and compliance objectives are met. Assist business in remediating findings from investigations, audits, monitoring and other OEC assessments, keep applicable OEC members apprised of relevant information from IRCs, CAPAs, and day to day business issues that impact OEC initiatives.

Requirements:

  • Bachelor's degree is required.
  • One (1) to three (3) years' experience leading employees and projects.
  • Minimum of five (5) years Pharma and/or related experience.
  • Healthcare compliance experience supporting a medical organization preferred

Eligibility Requirements:
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older

Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Candidates need to use the following link to apply for the role:
 Job Description - Associate Director, Compliance Business Partner I - Research, Development & Medicine (215257) (taleo.net)

Posted 5/4/2021

DIRECTOR, GLOBAL BUSINESS COUNSELING AND SUPPORT - Merck & Co., Inc.
2 positions
Locations:
1 in Jersey City, NJ and 1 in Lansdale, PA US


Merck & Co., Inc., Kenilworth, New Jersey, USA, has made the decision to spin-off products from its Women's Health, trusted Legacy Brands, and Biosimilars businesses to form a new, independent company. This new company, named "Organon", will become an independent, publicly traded company in 2021 with its global and US headquarters to be based in Jersey City, NJ. We expect that additional Organon sites will be in the general vicinity of current Merck & Co., Inc. locations.

For this exciting new opportunity, we are seeking candidates with an entrepreneurial and learning spirit who are interested in a career of purpose, personal growth and leadership. Working together, we will make a significant impact on the health and lives of people around the world. For more information about Organon, please click here.

 

Job Description
The Director, Global Business Counseling and Support -- (GBC) will support the goal of the Ethics and Compliance Organization to be a "partner in doing the right thing – all the time." The GBC will be responsible for compliance support for the NewCo business, primarily focusing on marketing and sales issues as well as medical affairs, but also supporting other functions as needed. The GBC will pro-actively support client teams in the effective execution of compliant business practices by partnering with them in setting and consulting on policies, providing training and best practices, promoting compliant behaviors, raising issues, and supporting corrective action.

Examples of responsibilities and duties of the position include:

  • End-to-end compliance support to marketing and sales personnel and medical affairs personnel
  • Understanding the business needs, strategic objectives, and operational practices of the client organizations Member of business leadership teams as assigned
  • Provide launch support for marketing and sales teams
  • Oversight and monitoring planning and support
  • Audit support
  • Assigned points for certain Ethics and Compliance-owned policies
  • Cross-functional team support as assigned
  • Having subject matter expertise in the relevant guidance, policies, codes, and regulations, as well as in their applications to the business—including familiarity with at least some of the following: the U.S. anti-kickback statute, State gift laws,  fundamentals of U.S. pharmaceutical product promotion regulation, the PhRMA Code on Interactions with HCPs and similar matters.
  • Applying this expertise in advising and counseling clients on new issues, answering routine questions regarding policy, and assisting in the assessment and implementation of new activities 
  • Assisting in the development and communication of compliance objectives and initiatives to US business stakeholders
  • Maintaining full line-of-sight (from strategic intent through tactical execution) when supporting line management in the development of new or refined guidance to ensure that they are relevant, appropriate, and implementable.  Steps include gathering input, authoring, circulating drafts, gaining necessary approvals, developing communications plans, and integrating the guidance into new or existing training.
  • Utilizing brand knowledge, review materials as part of the Promotion Review Team
  • Providing proactive identification of compliance risks and gaps and leading the development of solutions
  • Developing strong working relationships with key stakeholders in business partner areas, and throughout the compliance organization and legal organization

Education:

  • BA/BS required; advanced degree in business, marketing, law, audit or public policy preferred

Requirements:

  • High degree of ethics and integrity
  • 10+ years business experience (5+ years pharmaceutical industry preferred)
  • Self-motivated and proactive
  • Familiarity with sales or marketing organizations and activities, as well as medical affairs organizations and activities
  • Experience with the development or execution of written policies, guidance, laws, rules or regulations or other significant drafting or writing experience
  • Training or presentation experience in individual or group situations
  • Experience/comfort working with senior managers, and Legal organizations
  • Ability to influence and exercise good judgment
  • Ability to apply knowledge to real world situations
  • Ability to translate and communicate complex concepts clearly
  • Ability to manage multiple projects simultaneously and prioritize activity in alignment with business goals
  • Strong judgment and decision-making skills regarding compliance related topics
  • Strong written and oral communications skills

#NewCo

Our Support Functions deliver services and make recommendations about ways to enhance our workplace and the culture of our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.

US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here. if you need an accommodation during the application or hiring process.

  For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular
Relocation: No relocation
Number of Openings: (2 – 1 in Jersey City, New Jersey and 1 in Lansdale, Pennsylvania)
Requisition ID: R94229

Organon Vision
Organon will improve the lives of people globally by unleashing the promise of trusted brands across women's health and other important therapeutic areas.

We are committed to becoming the world's leading women's health company investing in innovations that support women's well-being

Organon Mission
Invest in innovations to support women's well-being, fueled by our leading contraceptives and fertility business.

Establish a leading position in biosimilars, focusing on oncology and inflammatory diseases, and being a partner in the commercialization of biosimilars worldwide.

  Realize the value of trusted dermatology, pain and cardiovascular portfolio.

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 Apply here
Posted 4/16/2021

COMPLIANCE - HCP ENGAGEMENT LEAD - PHARMA - Shionogi Inc.
Location: Florham Park, NJ US


The HCP Engagement Lead manages Compliance processes related to evaluation and execution of Healthcare Professional (HCP) engagements and interactions with Healthcare Organizations (HCOs). Will support the needs of business owners while simultaneously ensuring potential risks are evaluated and mitigated appropriately. Will also serve as a core member of the Compliance Team and represent Compliance on committees related to HCP/HCO activities.

RESPONSIBILITIES

  • Manage the Compliance Review Committee (CRC) process, which has corporate responsibility for ensuring appropriate interactions with HCPs and HCOs;
  • Conduct substantive review of all requests for engagement of HCPs and interactions with HCOs that are submitted to Shionogi's CRC. Review includes, but is not limited to, an evaluation of the following parameters: needs assessments, activity details, HCP attributes and credentialing, activity venue (if applicable), Shionogi participants, accounting for deliverables, etc.;
  • Work closely with CRC Coordinator to ensure that requests are reviewed in a timely manner;
  • Liaise with business owners to ensure understanding of business needs and project details;
  • Conduct HCP licensure checks, debarment screenings, exclusion screenings, and other diligence, as required, relevant to HCP engagements;
  • Review and apply output from Medical Affairs HCP credentialing process. Escalate exception requests to Vice President, Compliance, as required;
  • Manage the process for determination of Shionogi's FMV rates. Identify and assign appropriate Fair Market Value (FMV) rates for HCP engagements utilizing Shionogi's FMV Rate Card;
  • Populate HCP contracting templates as required by engagement type;
  • Collaborate with Shionogi Legal on HCP/HCO requests for contract modifications;
  • Serve as Compliance representative during Medical Review Committee (MRC) meetings, as needed (Compliance is an ad-hoc member of the MRC);
  • Liaise with colleagues in Japan and Europe on multi-regional projects related to HCP engagement. Drive consistency and optimization of processes for cross-border HCP engagements; and
  • Support the VP Compliance in additional activities, as requested, which may include but not limited to the following: periodic monitoring and auditing of HCP activities; internal investigations related to HCP/HCOs; inquiries related to HCP spend data reporting (e.g., Sunshine Act review/disputes).

REQUIREMENTS

  • Bachelor's Degree required; additional paralegal or legal training preferred.
  • 5 plus years of Compliance and/or Legal Department work experience in a regulated industry such as: Pharmaceutical, Medical Device and /or other Life Science industry.
  • Able to draft contractual documents and have familiarity with related laws.
  • Self-motivated, proactive, and able to manage tight deadlines and/or multiple projects with limited supervision.
  • Strong organizational, analytical and interpersonal skills.
  • Strong verbal and written skills; must be clear and concise with individuals and groups - internally and externally.
  • Demonstrated success as a subject matter expert with regard to related compliance issues.
  • Familiarity with government databases is preferred.
  • Must be detail-oriented and show comfort as both a team player and an individual contributor.
  • Should be solutions-oriented in approach to decision making.
  • Travel is estimated not to exceed 15%.
  • Proficient in MS Word, MS Excel, MS PowerPoint, Adobe Acrobat and technology in general.
  • Ability to operate a computer keyboard, and to view video display terminal images up to four (4) hours at a time.

To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.

DISCLAIMER
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.

EEO

Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.

Interested parties can go to https://www.shionogi.com/us/en/careers.html to learn more and apply for the position.
 Apply here
Posted 4/13/2021

ASSOCIATE DIRECTOR, ETHICS & COMPLIANCE, US - Alnylam
Location: Cambridge, MA US


Overview
Alnylam is the world's leading RNA interference (RNAi) company.

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,500 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work six years in a row (2015-2020), a Great Place to Work in the U.K. and Switzerland two years in a row (2019-2020) and a Science Magazine's Top Employer two years in a row (2019-2020). Please visit www.alnylam.com for more information.

Reporting to the Senior Director, U.S. Ethics and Compliance, the Associate Director will lead the design, implementation, and enhancement of an effective ethics and compliance program for Alnylam's US Business. The Associate Director will work closely with colleagues in the broader Ethics & Compliance team, and with regional Legal and business colleagues to sustain Alnylam's strong ethical culture and ensure employee adherence to the Company's Code of Conduct and related rules, policies, and procedures.

Summary of Key Responsibilities

  • Employ soft leadership skills with employees and leadership to maintain and enhance throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization with a spirit of partnership and positive problem solving
  • Assist Compliance Leadership Team with efforts to evolve the compliance program within the US Region to ensure it is consistent with Alnylam's values and principles, that it is fit for purpose and complies with applicable requirements
  • Draft and/or update appropriate policies to ensure compliance with applicable laws, regulations and industry codes and alignment with global policies
  • Prepare and deliver training and education to ensure understanding of employee responsibilities and ethics and compliance issues, as well as related policies and procedures
  • Execute routine and risk-based monitoring and auditing of relevant US Business activities and related policies and procedures; identify potential areas of compliance vulnerability and risk; ensure corrective action plans are implemented when required; and generate reports on monitoring, auditing and risk assessment for the US Business
  • Maintain (and in some cases create) records management and documentation systems instrumental to a successful Compliance program
  • We are a lean organization - the ability (and willingness) to move between routine administrative and more senior-level work is a must
  • Position is based in Cambridge. Travel required once Covid restrictions are lifted
  • Other responsibilities as may be assigned from time to time in the company's discretion

Qualifications

  • Bachelor's Degree required. Other relevant accreditations a plus
  • Minimum of 8 years ethics, compliance and/or related legal experience in an organization subject to US biopharmaceutical, medical device or other relevant healthcare compliance laws and regulations
  • Deep knowledge of (and experience with) laws and regulations applicable to global pharmaceutical companies, including US fraud and abuse and false claims laws, and PhRMA Code on Interactions with Healthcare Professionals
  • The ideal candidate will have Compliance Business Partner Experience
  • Must be able to work collaboratively in a team environment on a broad range of matters with a wide variety of company personnel, including physicians, scientists and individuals of different nationalities - you will lead the way to appropriate risk decisions by combining your deep knowledge of compliance, your soft leadership skills, and extraordinary tact
  • Ability to lead multiple projects simultaneously, to work independently and manage discrete areas of responsibility without direct supervision, and to flourish in a fast-paced and high energy environment. You must be willing to flex into new areas with enthusiasm and sound judgment
  • Able to thrive in a proactive ethical culture in which compliance and business objectives are mutually reinforcing; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the Company's business and culture
  • Excellent organization, communication (verbal and written - fluency in English required) and prioritization skills, including the ability to communicate concisely with senior leaders, to integrate legal and business considerations, and to provide balanced advice regarding risks to all levels of the organization from junior marketers to SVPs
  • Absolute willingness to treat role as a growth opportunity

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

 Apply here
Posted 4/9/2021

COMPLIANCE MANAGER - Otsuka
Location: Princeton, NJ US


Job Summary
Compliance Manager will report to Compliance Counsel in Ethics & Compliance (E&C) to support the effective implementation of the company's comprehensive compliance program.

Job Description

  • Work with Compliance Counsel and the compliance analytics team to build out a robust analytics tool to assess compliance risk. This would include reviewing, interpreting, and creating dashboards based on company data to allow for more robust compliance analytics and reporting capabilities.
  • Assist Compliance Counsel in providing risk mitigation guidance and support to CNS franchise and Commercial Operations business teams.
  • Work directly with sales management to address potential issues identified during call note review, email review and/or expense report reviews.
  • Work closely with the E&C training department to develop relevant compliance content and guidance documents for field-based employees and others.
  • Provide compliance support to Sales Operations including drafting field communications in furtherance of compliance objectives.
  • Monitor state laws and regulations related to detailer licensing and sales representative registration requirements and ensure company compliance with the same.
  • Provide live monitoring support for field-based activities.
  • Provide additional support to the E&C team as needed.

Qualifications
Required

  • Bachelor's degree required
  • At least 3 years of substantive corporate compliance experience.
  • In-depth understanding of US healthcare industry laws and regulations.
  • Strong interpersonal, writing, communication, organizational, project management and presentation skills.
  • Experience in handling confidential and sensitive situations or information with an ability to exercise a high degree of judgment and discretion.
  • Up to 20% travel based on business needs.

Preferred

  • Juris Doctorate degree
  • Data analytics background

Come discover more about Otsuka and our benefit offerings;
https://www.otsuka-us.com/careers-join-otsuka

Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

 Apply here
Posted 4/6/2021

SR. COMPLIANCE COUNSEL - Neurocrine Biosciences
Location: San Diego, CA US


Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve patient suffering and enhance lives.

What We Do:
Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, with three pivotal and five mid-stage clinical programs in multiple therapeutic areas. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. (*in collaboration with AbbVie)

About the Role:
Responsible for broad compliance consultation and recommending continuous solutions for the Neurocrine Compliance and Ethics program to ensure compliance with all applicable laws and regulations.

Your Contributions (include, but are not limited to):

  • Provide clear and sound compliance advice to key stakeholders, executive management and employees at Neurocrine, consistent with applicable laws, regulations and Neurocrine policies
  • Act as advisor and provide compliance input and expertise into business decisions, including development of solutions-orientated risk mitigation strategies
  • Provide proactive risk assessments regarding the compliance/ethics program and provide recommendations for updates/changes to the program or business operations as needed
  • Oversee compliance investigations regarding allegations of potential violations of law, company policy and/or ethical standards, prepare recommendations based on results of the investigations and implement corrective actions
  • Proactively conduct monitoring and auditing to ensure compliance with applicable laws, regulations and Neurocrine policies, including field rides, speaker programs and advisory boards
  • Assess compliance training needs, develop and deliver effective and creative training, including written materials, computer-based training and live presentations
  • Perform other duties as assigned/requested

Requirements:

  • BA/BS Degree and Juris Doctorate Degree and 10 years of legal and/or compliance experience, including a minimum of 3 years with the biotech/pharmaceutical or medical device industry
  • An active license to practice law in any state preferred
  • Ability to independently identify, analyze and render legal advice on complex issues
  • Ability to deliver clear, concise and accurate advice, including the appropriate level of detail and anticipation of follow-up questions
  • Ability to build consensus with diverse stakeholders and third parties and form strong, collaborative working relationships with clients
  • Expertise with respect to corporate compliance is required
  • Recognized as external expert in a strategic job function
  • Requires broad and comprehensive expertise in leading-edge theories and techniques within a strategic job function
  • Applies ingenuity and creativity to problem analysis and resolution in complicated and/or novel situations
  • Influences internal/external business and/or industry issues that have an impact on Neurocrine
  • Ability to drive strategic direction into tactical plans
  • Ability to lead multiple teams
  • Strong leadership, mentoring skills and abilities typically supervises lower levels and/or leads indirect teams
  • Exceptional communications, problem-solving, analytical thinking, influencing skills
  • Sets broader picture and longer-term vision for department
  • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
  • Excellent project leadership skills
  • Research skills
  • Decision-making and planning skills
  • Organizational skills

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

Please apply directly via www.neurocrine.com
 Apply here
Posted 4/2/2021