The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

DIRECTOR, COMPLIANCE - AUDITING & MONITORING - Idorsia
Location: Philadelphia Area - Radnor, PA, PA, US


The purpose of Idorsia is to discover, develop and bring more, innovative medicines to patients. We have more ideas; we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland, the US Commercial Operations & Clinical Development teams are based near Philadelphia, Pennsylvania. Idorsia is committed to meet the changing needs of healthcare professionals, patients and their families. The core of what we do is to bring creative solutions to the market based on our science and data.

The Director, US Compliance Auditing and Monitoring is responsible for identifying current Compliance risk areas and establishing auditing and monitoring approaches to evaluate company adherence to US regulations and Idorsia Policies and Procedures. This role will be expected to use technology, analytics and traditional live monitoring and records review activities to help Idorsia's US business identify and appropriately remediate potential concerns. These activities will include, but not be limited to, planned risk assessment and subsequent monitoring/auditing activities as well as ad hoc assessments and investigations necessitated because of helpline communications or monitoring/auditing finding.

Key Responsibilities:

  • Conducts live field monitoring of Commercial and Medical Affairs activities.
  • Conducts transactional monitoring of records and systems including but not limited to: patient assistance programs, arrangements and interactions with Independent Charity PAPs, expense reporting, medical information requests, educational grants and other external funding requests and consulting and advisory engagements with healthcare providers.
  • Prepares reports, presentations, and dashboards for numerous audiences, including Idorsia Leadership and the Idorsia Compliance Committee, that summarize monitoring and auditing findings and remediation.
  • Develops and implements an appropriately scaled risk assessment and management process and prioritizes monitoring activities and mitigation plans in accordance with that process.
  • Oversees the remediation and corrective action process for the Compliance team.
  • Conducts ad-hoc monitoring and auditing as necessitated by investigations carried out by the Compliance Department.
  • Develops appropriate data analytics and use of innovative technology to expand and advance monitoring capabilities.
  • Contributes as needed to the preparation of Government reporting, including reports required under the Open Payments law and state law monitoring and reporting.

Qualifications:

  • Minimum of 10 years of healthcare compliance monitoring and auditing experience with a pharmaceutical/biopharmaceutical company or within the life sciences industry.
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute, False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, HIPAA, Open Payments, and relevant industry guidance, specifically the PhRMA Code on Interactions with Healthcare Professionals.
  • Ability to manage multiple projects to completion on-time, meeting internal and external deliverables with high degree of accuracy.
  • Ability to interact with Idorsia employees at all levels of the organization.
  • Team player with strong interpersonal skills.
  • Strong oral and written communication skills.
  • Ability to work collaboratively and independently as the circumstances require.
  • Self-motivated and detail oriented.
  • Highest level of ethics and personal integrity.
  • Ability to travel domestically up to 25%.

At Idorsia, we harness the power of difference, authenticity and inclusion to achieve business success. We are committed to fostering respect, fairness and equal opportunities for all job applicants and all our employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you will be informed in greater detail in due course.

Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, please note that all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.


 Apply here
Posted 7/22/2021

ASSOCIATE DIRECTOR, HCC MONITORING & AUDITING - Insmed
Location: Bridgewater, NJ, US


Company Description
About Insmed:
Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.

Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.

Overview
About the Role:
Reporting to the Director, Risk Assessment, Monitoring and Auditing, this role will serve as the lead for the Healthcare Compliance Auditing, Monitoring and Risk Management team. The incumbent will guide and direct healthcare compliance auditing and monitoring life cycle, from conducting risk assessment through creation of the annual monitoring and auditing plan through conduct of those activities and creating and assessing results and metrics. This role will be based at our Bridgewater, New Jersey headquarters location.

This is a non-supervisory position. This position may need to oversee and supervise vendors who conduct monitoring and auditing on Insmed's behalf.

Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following:

  • Conduct healthcare compliance monitoring include live activities in the US (e.g. field rides, speaker programs, congresses) and records review globally (e.g. travel & expense, healthcare professional engagements)
  • Conduct healthcare compliance audits in the US (e.g. patient services, speaker's bureau) and pertaining to global functions (e.g. grants, medical information, publications)
  • Conduct audits of third-party vendors as assigned
  • Effectively partner with the business to communication findings or observations
  • Track remediation for all monitoring and auditing activities
  • Support the Director to capture and report metrics in a meaningful and engaging manner that helps the Global Compliance Leadership Team and other senior leaders understand Insmed's global compliance risk profile
  • Support annual risk assessment and annual monitoring and auditing plan development
  • Develop and maintain ongoing relationships with EMEA and Japan Compliance Officers and across various functions, as applicable.

Qualifications
About you:

  • Bachelor's degree required
  • Pharmaceutical compliance certification is a plus
  • At least 7 years' experience in healthcare compliance monitoring or auditing for a pharmaceutical or biotech company
  • Knowledge of US compliance regulations, laws and standards
  • High level of familiarity with broad range of compliance risk areas, relating to business practices of a U.S. business
  • Ability to quickly learn global compliance regulations, laws and standards to partners with Compliance Officers outside the US
  • Experience in conducting healthcare compliance monitoring (live field rides, live speaker programs, records reviews)
  • Experience in conducting healthcare compliance audits
  • Independently produce accurate reports and articulate correspondence.
  • Able to manage varying and high workload and sets priorities accordingly to support Director efficiently and in a solution-oriented manner
  • Produces high quality work with minimal oversight from Director
  • Possesses a 'can-do' attitude and the ability to work independently yet collaboratively with internal business partners
  • Must have excellent communication skills (verbal and written)
  • Must have strong writing skills
  • Highly organized with a strong attention to detail, clarity, accuracy, and conciseness
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)

Additional Information
Travel Requirements:

  • Domestic travel required (10-20%). Some international travel could occur in rare instances.
  • Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.
  • Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
  • Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.
 Apply here
Posted 7/13/2021

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