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EMPLOYMENT OPPORTUNITIES

 

US INTEGRITY & COMPLIANCE AUDITING LEAD - Indivior
Location: Richmond, VA (Relocation assistance provided for non-local candidates)
Richmond based hybrid position (Tues-Thurs in office)
Full time
Reports To: US Integrity & Compliance Officer
Job requisition id: R2477

Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline "Focus on you" makes the company's commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

POSITION SUMMARY:
The Integrity & Compliance (I&C) Auditing Lead is tasked with enhancing and implementing Indivior's Healthcare Compliance Auditing program. This includes leveraging analytical approaches and technology to improve the program's effectiveness and efficiency, leading continuous improvement projects, and supervising the I&C auditing activities of third-party consultants.

ESSENTIAL FUNCTIONS:
The responsibilities of this role include, but are not limited to, the following:

• Develop and enhance Healthcare Compliance Auditing protocols, procedures, and training materials.
• Support annual Healthcare Compliance Risk Assessment & Mitigation Planning activities and develop risk-based auditing plans.
• Conduct audits and monitoring activities to ensure compliance with Indivior requirements, as well as those required by Indivior's Corporate Integrity Agreement (CIA).
• Develop Auditing testing criteria, analyze information, and identify and document observations and recommendations.
• Identify and implement continuous control monitoring opportunities.
• Enhance and maintain Audit dashboards and reporting tools.
• Collaborate with Internal Audit and Quality Audit functions and support external inquiries and audits.
• Develop and deliver training on A&M topics.
• Oversee A&M activities and consultants.
• Complete in-person field observations with Indivior commercial and medical field-based workforce.

MINIMUM QUALIFICATIONS:

• Education: Bachelors required, Graduate Degree preferred.
• Experience: 3-5 years of compliance risk management and auditing experience for a US life sciences company, accounting firm (e.g., forensic accounting), or healthcare consulting firm. Additional experience in commercial roles is valued, but not required.
• Preferred: Experience in Healthcare Compliance and implementing corporate integrity agreements.
• Travel: 30-40% as needed.

COMPETENCIES/CONDUCT:
In addition to the minimum qualifications, the employee will demonstrate:

• Strong project management, problem-solving, and critical thinking skills.
• Effective communication and interpersonal skills, with the ability to influence and drive change.
• Knowledge of pharmaceutical compliance regulations and government (e.g., FDA, OIG HHS) guidance affecting the pharmaceutical industry.
• Proficiency in data analytics software and power apps (e.g., PowerBI) and experience with report-building software (e.g., Tableau).

BENEFITS:
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes

• 3 weeks' vacation plus floating holidays and sick leave
• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay
• U.S. Employee Stock Purchase Plan- 15% Discount
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health and Dependent Care Flex Spending options
• Adoption assistance
• Tuition reimbursement
• Leverage Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
• Gym, fitness facility and cell phone discounts
• Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.

GUIDING PRINCIPLES:
Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

COMPLIANCE OBLIGATIONS:
Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:

Employee Obligations:

• Always act with honesty and integrity.
• Risk IQ: Know what policies apply to your role and function and adhere to them.
• Speak Up: If you see something, say something.

Manager Obligations:

• Always act with honesty and integrity
• Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
• Model and reinforce a Speak Up culture on your team.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY - EOE/Minorities/Females/Vet/Disabled

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Posted 8/21/2024

SENIOR MANAGER, CORPORATE COMPLIANCE - Crinetics Pharmaceuticals, INC.
LOCATION: San Diego, CA US
REPORTS TO: Director, Corporate Compliance
FLSA: Exempt
DEPARTMENT: Legal
GxP Related Y/N: N

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary:
The Senior Manager, Corporate Compliance is responsible for assisting the Compliance department in developing, implementing, and maintaining an effective Corporate Compliance program that supports and promotes a company-wide culture of ethics and compliance while ensuring all legal, regulatory, and ethical obligations of a pharmaceutical company are being upheld. The position will assist in executing the elements of Crinetics' compliance program, with an emphasis on auditing and monitoring of business activities, the management of transparency reporting (federal and state), and the annual compliance risk assessment.

Essential Job Functions and Responsibilities:
These may include but are not limited to:

• Collaborate with Compliance leadership and other cross-functional leaders to help support all aspects of the annual Compliance risk assessment.
• Assist in the development and execution of the annual Auditing & Monitoring plan.
• Objectively and independently conduct compliance audit reviews of business processes and activities to identify potential risks, assess internal controls, and evaluate the overall effectiveness of the Compliance program.
• Manage the third-party vendor day-to-day live monitoring activities and provide recommendations for remediation on all findings.
• Draft remediation plans and timelines and oversees the completion of agreed-upon remediation by assigned business owners.
• Partner with third-party vendor to manage and execute against all Federal and State reporting requirements, including Aggregate Spend reporting (i.e. Physician Payment Sunshine Act)
• Maintain an up-to-date knowledge and understanding of federal and state laws and regulations, industry codes of conduct applicable to the Company's policies, practices and operations, including but not limited to the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, regulations regarding the promotion of marketed products, clinical trial regulations and the False Claims Act and Anti-Kickback statute.
• Other duties as assigned.

Education and Experience:

• Bachelor's degree (advanced degree such as master's degree preferred) with at least 12 years of compliance related experience
• Certification of Healthcare Compliance (CHC) and/or Certified Compliance and Ethics Professional (CCEP) preferred
• Previous experience in a compliance role including the day-to-day management and execution of an auditing and monitoring program, and the management of all federal and state reporting requirements
• Demonstrated ability to work collaboratively across multiple departments with strong interpersonal and communication skills
• Ability to interact and present to various internal stakeholders
• Ability to successfully manage, synthesize and communicate complex information in an effective manner
• Ability to work independently, identify opportunities, explore options and recommend solutions through strong critical thinking, problem solving and decision-making skills
• Experience with change management working in a high growth environment preferred

Physical Demands and Work Environment:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:
You may be required to travel for quarterly on-site meetings and up to an additional 5% of your time.

The Anticipated Base Salary Range: $111,000-$148,000
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Vaccination requirement:
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. They are representative of those knowledge, skills, and abilities that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

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Posted 8/21/2024

SENIOR DIRECTOR, OF GLOBAL TRANSPARENCY AND COMPLIANCE ASSURANCE - Madrigal Pharmaceuticals
Location: West Conshohocken, PA US

The Senior Director, of Global Transparency and Compliance Assurance is responsible for assisting the Compliance Officers and the Chief Compliance Officer with the implementation and management of Madrigal's Compliance Program. This includes supporting efforts to continuously enhance Madrigal's Compliance program based on the legal enforcement environment in the U.S. through the application of best practices in the life sciences Compliance space. This role requires significant experience with building and managing Compliance programs such as Transparency reporting infrastructure, Investigations and Monitoring programs. This role requires interaction with other members of the Compliance and Legal teams as well as Sales and Marketing, Information Technology, Finance, Market Access, Medical Affairs, R&D and other functions.

Position Responsibilities:

• Work with other members of the Compliance and Legal team to maintain and enhance the infrastructure for the U.S. business that supports a company culture of compliance and recognizes that compliance is a collective responsibility of all company employees
• Develop tools, processes and reports to support the U.S. business's ownership of Compliance
• Participate in routine meetings with U.S. business partners
• Create and deliver function-specific trainings and communications
• Assist with evaluating and remediating monitoring and investigation findings
• Assist with conducting annual compliance risk assessments, including evaluating results and identifying areas of improvement
• Conduct field monitoring activities and other office-based auditing/monitoring
• Provide guidance to the U.S. Business and integrate compliance controls into the scope of existing business practices where applicable
• Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state transparency requirements, state and federal privacy laws, OIG and DOJ guidelines, PhRMA code and state marketing compliance laws
• Support Investigations and Monitoring program as needed
• Other duties and special projects as assigned

Qualifications and Skills

• Bachelor's degree required; advanced degree (JD or CPA) and/or people management experience preferred
• Minimum of 10 years of pharmaceutical/life sciences compliance experience
• Proven record of accomplishment in the areas of U.S. compliance best practices
• Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry
• Ability to communicate effectively in both verbal and written form with multiple stakeholders within and outside the company
• Ability to collaborate and work effectively with cross-functional teams and projects
• Strategic leadership capability, strong organizational awareness, sound judgment, strong business acumen and ability to make decisions with the input of appropriate input from multiple stakeholders
• Strong problem solving and risk analysis skills
• Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks
• Position is designated as remote; however, 25% travel is required and ability in particular to readily access office locations in either Conshohocken, PA and/or Waltham, MA

Compensation:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals' Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal's name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.

Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.

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Posted 8/15/2024

ASSOCIATE DIRECTOR - LEAD E&C TRANSPARENCY OPERATIONS - Takeda
Location: Hybrid, Lexington, MA US

OBJECTIVES/PURPOSE

• Ethical behaviour plays a fundamental role in risk mitigation
• Being a forward-thinking leader in risk identification and mitigation
• Building a modern function supporting achievement of Takeda's Vision 2025

E&C will respond rapidly to changing environment and business needs, it is close to the market, and encourages ethical behaviour in line with Takeda's values. By working in an agile manner E&C ensures the balance between stable structures, governance, processes and systems, and dynamic approaches to delivering innovative solutions to appropriately manage our risks.

E&C commits to

• Act as role model for Takeda's values, ethics and values-based decision making, fostering this mindset in clients, partners and team
• Enable the organization to take decisions which are ethical and in line with our priorities of Patient, Trust, Reputation, and Business
• Collaborate across all E&C teams and partner with stakeholders in BU / BF to embed ethics and compliance as part of the way everyone works at Takeda

RESPONSIBILITIES

Transparency

• Lead USBU Ethics & Compliance (E&C) efforts to manage and enhance the US Transparency Operations capability
• Act as the business owner of the Transparency system; serve as primary liaison with the system vendor and Takeda IT support team
• Program manage issues, exceptions data remediation and system enhancement requests
• Lead data collection efforts for Federal and State Transparency reports as well as State Sales Rep and Marketing Disclosure Reports (Nevada, Washington DC, etc.)
• Prepare, confirm and submit all required State and Federal Transparency-related Reports / Disclosures and FDA Samples report
• Monitor for Federal and State transparency-related limits, caps, and restrictions
• Create a cadence for performing monitoring, remediation and analytics (daily, weekly, monthly, etc.)
• Manage the development and implementation of business processes, data taxonomy, and data collection designs and methods that will enable Takeda to support current and future Federal and State disclosure reporting requirements
• Communicate transparency-initiative status, progress, and data analytics on a regular basis to stakeholders both across the US region and the company
• Develop data analysis and monitoring mechanisms to test, validate, trend, and understand transparency data
• Train and manage internal and external users of the Transparency system, including management of third-party vendors who submit data feeds
• Collaborate cross functionally within the USBU, across the US region and across the company regarding the Transparency program, requirements as well as process improvement areas identified through monitoring, execution and analytics
• Manage the Transparency operations team members

CAPABILITIES

• Extensive knowledge of Federal and State Transparency Laws and related restrictions
• Ability to work with data, databases and reporting platforms
• Proficient in PowerBI or Tableau, Excel, and PowerPoint
• Excellent written/verbal communication, analytical and presentation skills
• Capability to lead and facilitate discussions with senior leaders within a business unit
• Demonstrated ability to work cross-functionally in a highly matrixed environment
• Consistently demonstrates the ability to deliver results
• Able to work and deliver on deadlines while managing multiple projects and priorities effectively
• Ability to rapidly assimilate to new functional scope responsibilities
• Strong customer-service skills while interacting with all levels of management, field sales, marketing, marketing and sales vendors and partners
• Understanding of how to translate transparency data into insights, actionable process, policy, SOP, and/or system improvements

EXPERIENCE

• 8+ years of legal, compliance or commercial experience, of which at least 5 years in the healthcare or pharmaceutical industry in a U.S. Transparency-related role
• Experience leading teams and managing vendors
• Proven ability to work successfully with others and collaborate with cross functional areas to identify needs, provide guidance, and communicate solutions
• Bachelor's degree required
• Experience with laws, regulations and industry guidance that affect the pharmaceutical industry including, but not limited to, OIG and PhRMA guidelines, healthcare standard operating procedures, anti-bribery laws

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Flexible Ways of Working
• Tuition reimbursement

More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
#LI-hybrid

Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location: Lexington, MA
U.S. Base Salary Range: $149,100.00 - $234,300.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.?The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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Posted 8/9/2024

ASSOCIATE DIRECTOR, COMPLIANCE - Kiniksa Pharmaceuticals
Location: Hybrid, Lexington, MA US

About the job
Reporting to the Senior Director, Compliance, the Associate Director, Compliance will serve an important role in Kiniksa's continued enhancement of its Compliance program. This position will provide a broad range of compliance support and work to assist in the implementation, maintenance, and continued improvement of Kiniksa's compliant and ethical practices and behaviors through close collaboration with internal and external business partners. The Associate Director, Compliance will also have primary responsibility for executing key elements of Kiniksa's auditing and monitoring program and ensuring compliance with US and global transparency requirements.

This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Responsibilities (including, but not limited to):

General

• Help identify new work processes, tools or resources that will have broad applicability throughout the organization and assist with the implementation of Compliance systems and processes
• Provide training to internal and external organizational clients on a broad range of topics including anti-bribery, FDA regulations, transparency reporting and company policies
• Assist in the development and maintenance of relevant Standard Operating Procedures, work instructions, and guidance documents related to key areas within Compliance

Transparency Reporting

• Oversee data collection and generation of US and global transparency reports and subsequent reporting of transparency reports to applicable authorities
• Maintains understanding of disclosure laws, regulations and applicable industry codes

Auditing & Monitoring

• Perform auditing and monitoring of Medical and Commercial activities to ensure compliance with applicable laws, regulations and company policies
• Review of Medical and Commercial documentation to ensure compliance with company SOPs and policies
• Partner with cross-functional colleagues to address detected noncompliance, including corrective actions when needed

Qualifications:

• Requires a B.A./B.S. degree or equivalent (Advanced degree preferred) with 7+ years in compliance, audit and/or other related experience required. Pharmaceutical experience required
• Certified in Healthcare Compliance (CHC) or Project Management Professional (PMP) a plus
• Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including global aggregate spend and other reporting/sunshine laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, and state marketing and price reporting compliance laws
• Experience with US and global transparency reporting
• Experience developing and executing audits and monitoring
• Strong operational and project management skills required
• Excellent organization, communication and presentation skills. Candidate must have strong team orientation and problem-solving skills
• Candidate must be able to work independently and prioritize multiple demands
• This position requires 35-40% travel
• Salary is commensurate with experience
• Kiniksa Benefits Summary - USA

All Kiniksa new hires whose roles require them to enter Kiniksa's physical offices will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Kiniksa will consider, among other things whether a proposed accommodation would create an undue hardship.

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Posted 8/7/2024

HEAD OF ETHICS & BUSINESS INTEGRITY GOVERNANCE, OPERATIONS AND RISK MANAGEMENT - NORTH AMERICA AND GLOBAL SPECIALTY CARE - Sanofi
Location: US / Cambridge (U.S.) / Cambridge Crossing / 450 Water Street - Office Building

Job Description Summary
This position is responsible for the successful management of Sanofi's North America (NA) and Global Specialty Care Ethics & Business Integrity (E&BI) governance, operations, and risk management. This supervisory and strategic position will work collaboratively with Global E&BI, Finance, Internal Audit, and other functional and business areas to execute risk assessments, enhance the management of third-party compliance risk, oversee E&BI governance and operations (including Executive Compliance Committee and Aventis Board meetings), and provide compliance support for mergers & acquisitions. Integral parts of this role include identifying areas for continuous improvement, strategic planning and oversight of the enhancement of E&BI operations and systems across NA, and facilitating relationships with key stakeholders including the global E&BI leadership team, executives, Compliance Committee, and Board.

This management role will report to the VP, E&BI, NA and Global Specialty Care. This position oversees work conducted by direct reports and outside consultants. This role exercises independent judgment in assessing and providing strategic oversight of compliance-related matters.

I. Essential Job Duties and Responsibilities

• Integrate automation, digitalization and process simplification to continuously improve Sanofi's compliance program
• Provide day-to-day oversight of and enhance all elements of the NA E&BI Risk Assessment program and drive related strategic interface with other risk-management functions across NA, key business stakeholders, and the global E&BI risk management team
• Manage and enhance the NA E&BI third-party risk, collaborations and business development program
• Oversee NA E&BI Governance including managing Aventis Board and executive Compliance Committee materials; helping to further develop and track the E&BI NA compliance strategy; and strategic project management, function budget oversight, and vendor management
• Oversee NA E&BI Compliance Operations, including maintaining / enhancing E&BI systems, overseeing the Conflict of Interest and Compliance Champions Programs; managing appropriate processes to satisfy required industry code and state compliance related certifications
• Ability to prioritize multiple projects and responsibilities and effectively develop and oversee a team in a fast-paced environment, while maintaining positive collaborative relations with various senior stakeholders
• Set strategic Risk Assessment priorities, working closely with global E&BI, Internal Controls & Audit
• Maintain strict confidentiality and discretion
• Assist with aspects of Sanofi's Corporate Integrity Agreement compliance

II. Required Educational Background and Job-Related Experience

• Proven track record leading and managing risk assessments and third-party risk functions focused on issues such as bribery, fraud, corruption, and overall healthcare compliance.
• Experience in developing and overseeing compliance program governance, systems, tools and resources
• Established leadership skills, including managing and mentoring effective teams
• Demonstrated ability to manage and lead change in a large, matrixed organization
• Minimum of 10 years of life sciences/pharmaceutical/healthcare experience
• Excellent written, oral, and presentation skills

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Posted 7/30/2024

HEALTHCARE COMPLIANCE SPECIALIST - Grifols
Location: Hybrid with location in Research Triangle Park, NC US
Type: Regular Full-Time
Req ID: 515389
Job Category: Legal / Compliance

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Position Overview:
The Compliance Specialist supports the North American Healthcare Compliance organization in administration of an effective US healthcare compliance program. He or she will work internally to support compliance processes and procedures. The position can have a US or global scope of work.

Responsibilities include but are not limited to:

• Support compliance process and procedure development, documentation, and implementation
• Support compliance monitoring and auditing program; including retrospective and field based assessments
• Assist in the collection, aggregation, analysis and reporting of compliance data to internal and external parties
• Investigate and document compliance issues and concerns
• Assist in monitoring and implementation of compliance training program
• Support development and revision to compliance training
• Provide guidance and clarification to customers on compliance polices and regulations
• Support ad hoc compliance projects
• Work collaboratively with compliance colleagues to meet company objectives and serve customers

Skills/Qualifications/Education: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• Bachelor's degree with 2 years' experience or equivalent combination of education & experience
• Familiarity with US healthcare compliance laws and regulations preferred
• Ability to travel 15% primarily within the US
• Exposure to US and international commercial operations preferred
• Ability to conduct audits with guidance
• Strong attention to detail
• Ability to issue spot straight forward issues and analyze data for patterns and inconsistencies
• Understands how work fits into larger business
• Demonstrates leadership skills and interest
• Strong interpersonal skills
• Strong verbal and writing skills
• Ability to communicate effectively
• Strong ethics, concern for standards, and desire to help others do the right thing
• Ability to perform duties with the highest degree of confidentiality, objectivity, and fairness
• Ability to work independently
• Understands the purpose and components of presentations and is able to develop a presentation and present to a small group
• Ability to deliver basic training live or electronically
• Ability to draft basic policies and procedures with guidance
• Ability to support investigations with guidance
• Ability to identify risks and analyze data for patterns and inconsistencies
• Proficient with standard PC software
• Obtains professional development annually, including learnings from outside the company

*Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations and frequently travels within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
#LI-CB1

Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.

Learn more about Grifols.

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Posted 7/30/2024

SR. COMPLIANCE AND ETHICS SPECIALIST - Neurocrine Biosciences
Full Time
Location: On-Site, San Diego based US (min 40% travel)
Job Requisition ID: R4809

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 suffering for people with great needs, but few options.

What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:
The Sr. Compliance and Ethics Specialist will be primarily responsible for executing key elements of Neurocrine's compliance monitoring program. The position will also support other compliance responsibilities including those related to internal investigations, training, communications, spend transparency, and special projects. The role is located at Neurocrine’s San Diego headquarters.

Your Contributions (include, but not limited to):

• Conduct field and desk monitoring to ensure compliance with applicable laws, regulations, and Neurocrine policies
• Assist in developing annual plans for monitoring activities such as Sales and Medical Affairs field rides and peer to peer educational program monitoring
• Track and report progress of Compliance monitoring, including preparation of reports/metrics to communicate findings throughout multiple levels of the organization
• Assist in the development and execution of compliance analytics that identify trends, patterns or outliers that help drive risk-based actions and decisions
• Provide sound compliance guidance consistent with applicable laws, regulations and Neurocrine policies
• Support additional compliance initiatives and projects

Requirements:

• Bachelors degree or equivalent and 4+ years of relevant experience in the biotech/pharmaceutical or medical device industry
• Compliance and Ethics Professional Certification preferred
• Understanding of healthcare compliance laws, regulations, and industry codes applicable to a pharmaceutical company with a commercial product, including federal Anti-kickback Statute, FDA promotional regulations, federal and state spend transparency laws and the PhRMA Code
• Experience in compliance solutions for data analytics, monitoring and risk management preferred
• Strong ability to use word processing and presentation software to prepare documents and training, and to use spreadsheet and statistical analysis software to store, manipulate, analyze and present data
• Ability to manage multiple projects, meet deadlines, and adjust to changes in priorities
• Strong organizational skills and attention to detail
• Strong data analytics skills
• Strong critical thinking and problem-solving skills using creativity and sound judgment
• Strong written, verbal, and listening skills
• Strong teamwork and interdisciplinary collaboration skills
• Flexible to travel (minimum 40% of time)
• In-office 3+ days per week when not traveling
  #LI-TM1

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

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $99,200.00-$143,675.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

 Apply here
Posted 7/26/2024

COMPLIANCE COUNSEL - Neurocrine Biosciences
Full Time
Location: On-Site, San Diego based US
Job Requisition ID: R4810

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 suffering for people with great needs, but few options.

What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

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

Your Contributions (include, but not limited to):

• Conducts compliance investigations regarding allegations of potential violations of law, company policy and/or ethical standards, prepares recommendations based on results of the investigations and implements corrective actions
• Provides clear and sound compliance advice to stakeholders, management and employees at Neurocrine, consistent with applicable laws, regulations and Neurocrine policies
• Proactively conducts field and desk monitoring to ensure compliance with applicable laws, regulations and Neurocrine policies
• Provides proactive risk assessments regarding the compliance/ethics program and provides recommendations for updates/changes to the program or business operations as needed
• Acts as advisor and provides compliance input and expertise into business decisions, including development of solutions-orientated risk mitigation strategies
• Assists in addressing compliance training needs, helps to develop and deliver effective and creative training, including written materials, computer-based training and live presentations
• Performs other duties as assigned/requested

Requirements:

• Juris Doctorate Degree and 5+ years of legal and/or compliance experience
• An active license to practice law in any state
• Experience in the biotech/pharmaceutical or medical device industry
• Experience with healthcare compliance investigations
• 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
• Ability to anticipate business and industry issues; recommend relevant process improvements
• Excellent interpersonal skills
• Excellent communications, problem-solving, analytical thinking skills
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Ability to understand strategic direction and incorporate it into tactical plans
• Team player focused on team and organizational success
• Integrity, honesty, and trustworthiness are core operating principles
• Flexible to travel (minimum 30% of time)
• In-office 3+ days per week when not traveling
  #LI-TM1

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

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $202,300.00-$292,975.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

 Apply here
Posted 7/26/2024

US INTEGRITY & COMPLIANCE OFFICER - Indivior
Full Time
Location: Richmond, VA US / Hybrid
Reports to: Deputy Compliance Officer

Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company's commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

POSITION SUMMARY:
The U.S. Integrity & Compliance Officer (USICO) reports directly to the Deputy Compliance Officer (DCO) and assists the DCO with the day-to-day leadership and administration of the Indivior Global Integrity & Compliance Program (ICP).

The USICO serves as a strategic business partner and advisor across the U.S. Business Units (Behavioral Health, Addiction Sciences, Opioid Reversal Sciences) and Global Functions residing in the U.S. (e.g., Medical Affairs, R&D, Managed Care, Marketing, Government Affairs, Corporate Communications) to ensure the effective integration and implementation of the Indivior Global Integrity & Compliance Program. In this role the USICO will be responsible for providing timely proactive and daily compliance advisory counsel and compliant solutions approaches across the U.S. business, the annual administration of the U.S. I&C Risk Assessment and Mitigation Planning (RAMP) process with integration into the Global I&C RAMP, development/delivery of training, and participation in various compliance-related processes in collaboration with the Integrity & Compliance Centers of Excellence (e.g., monitoring, global strategy and program management, operations, reports communications, investigations (for subject matter expertise input only), governance committees, and government agreement administration).

The USICO is responsible to provide sound guidance and solutions that are in full compliance with the terms of Indivior Inc. Resolution Agreement (including CIA, DOJ Compliance Measures and FTC agreement).

The USICO is appointed to serve as Chairperson of the U.S. Compliance Administration Council (and may appoint a responsible delegate) and lead the I&C's policy governance program (with responsibility for all I&C Global and U.S. policies and procedures that are I&C-owned and in collaboration with those owned by other functions).

This position will have direct line reports and will also be responsible for indirect management of a network of Compliance Champions who support function level compliance activities.

ESSENTIAL FUNCTIONS:

• Work collaboratively in the development and evolution of the ICP, under the direction of the DCO and as guided by the Indivior Global Integrity & Compliance Program multi-year maturity strategy. USICO efforts will ensure effective and appropriately paced maturity within the Indivior U.S. Business Units, and U.S.-based Global functions in coordination with the I&C Officers.
• Lead and continually evolve the design, delivery and annual review of relevant I&C policies and SOPs based on U.S. laws, regulations, guidances, Industry Codes and Government Agreement requirements.
• Provide daily support and guidance and proactive risk and solutions identification as a business advisor to assigned U.S. Business Units and U.S.-based Global Functions. The USICO will embed and facilitate ongoing evolution of the Indivior Global Integrity & Compliance Program and effective support of corporate goals, in coordination with I&C Officers.
• Establish effective working relationships and build credibility within the Company, especially at senior management and operational leadership levels. The USICO will influence with and without direct authority to support a culture of integrity and compliance, confidence with quality decision making, and "speak up" without fear of retaliation.
• Lead a team that conduct the annual U.S. RAMP within the U.S. Business Units and functions, and advise senior management and operational leadership on issues concerning integrity and compliance matters including recommending controls designed to ensure compliance, while building independent Risk IQ across Indivior Business Units and Functions. The U.S. RAMP as a component of the Global I&C RAMP program must be executed in full conformance for consistency in approach and outcomes management. As such, the responsibility for the Global RAMP program is a shared responsibility between the USICO and the other I&C Officers.
• Build and develop highly engaged, effective team that consistently succeed in delivering value-added, timely, effective and pragmatic key stakeholder solutions that are risk and priority-based.
• Collaborate across Integrity & Compliance (I&C) to share insights from role, with active participation in the development of all relevant I&C activities, policies, training to ensure fit-for-purpose based on risk mitigation and business needs.
• Co-lead the effective design and delivery of relevant ad-hoc and standardized training for the U.S. Business Units and Functions together with the Global Training Center of Excellence.
• Engage in I&C monitoring and audits as assigned. In this role, the expectation is to conduct a moderate quantity of field observations to help inform awareness of business practices, risks and opportunities.
• Provide support for reports of concern assigned as "reviews" to the various functional areas for I&C advisory input.
• Serve as lead or member of assigned compliance governance committees, demonstrating strong policy and process development, administration and regular evolution skills.
• Engage in regular external networking and personal development to ensure maintenance of knowledge level of current regulations, Industry Codes and best practices (e.g., benchmarking), and strong working knowledge and application of Indivior policies and procedures, and all Indivior, Inc. Resolution Agreement requirements and commitments.
• Carrying out other tasks and activities related to the development, execution and maintenance of the ICP as assigned.
• Measure and report on Indivior Global I&C Program maturity initiatives and related progress, in addition to report development up to Board level for sufficient oversight based on the severity of any outcomes or matters under management (one on one, management committees, Board/Committees of the Board).
• Report on CIA compliance and implementation to U.S. Government Office of Inspector General Monitors at quarterly meetings as topics warrant; presence at all meetings.

KEY CHALLENGES:

• Engaging with diverse roles and individuals across U.S. region to ensure awareness, open dialogue and accessibility, while embedding confidence in ownership of compliance
• Providing timely, proactive and pragmatic approaches to deliver solutions to business needs and challenges within the governing standards of the Indivior Global Integrity & Compliance Program
• Effective time management and organization to manage multiple priorities, while simultaneously leading and driving key strategic priorities of the Integrity & Compliance function
• Create clarity through measurement and reporting of results delivered in role
• Effectively influencing quality decision making and change management while simultaneously driving an "operating with confidence" personal accountability; ensuring ownership and accountability for the ICP effectively rests with and is managed by the workforce at all levels of the organization

MINIMUM QUALIFICATIONS:
Education: BS/BA Undergraduate degree required.

Experience: Minimum 10 years of experience in either the pharmaceutical or medical device industry including a minimum of 5 years in a senior or regional healthcare compliance role and demonstrated experience effectively leading people in a supervisory capacity.

• Detailed understanding of U.S. regulations (including Industry Codes governing healthcare compliance programs).
• Strong interpersonal skills including ability to communicate effectively with people, individually and groups; ability to communicate with technical and non-technical colleagues; ability to develop important relationships with key stakeholders and work with all levels of management and employees, as well as with external partners and vendors.
• Excellent interpersonal, communication and presentation skills, with the ability to communicate complex issues in a simple way and influence for greater outcomes.
• Ability to work closely and collaboratively within Integrity & Compliance and with other business functions and Departments as well as key external stakeholders.
• Highly impactful people leader skills and an effective driver of the change management process.
• Experience in leading, planning, effectively executing and reporting on various healthcare compliance activities (e.g., training, risk management, monitoring).
• Effectively demonstrate expertise in Healthcare Compliance, leading to personal credibility and trusted advisor status among key stakeholder groups.
• Experience leading and advising within government agreement requirements and oversight is strongly preferred.
• Professional Compliance Certification required
• Law Degree or Master's Degree not required, but is preferred.

COMPETENCIES/CONDUCT:

• Flexibility in thinking and pragmatic problem-solving skills
• Excellent interpersonal, communication and presentation skills
• Strong influencing skills and ability to exercise sound, consistent business judgment
• Ability to work independently and manage a diverse and demanding workload
• Willingness to work in a dynamic, fast-paced environment
• High standards of professional integrity and independence, maintaining essential confidentiality.
• Able to effectively influence senior management and functions to drive change
• Displays a high sense of urgency and responsiveness, with quality and accuracy
• Flexible to travel (minimum 40-60% of time)
• Tenacity and robustness
• Effectively demonstrate expertise in Healthcare Compliance, leading to personal credibility and trusted advisor status among key stakeholder groups

BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:

• 3 weeks' vacation plus floating holidays and sick leave
• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay
• U.S. Employee Stock Purchase Plan- 15% Discount
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health and Dependent Care Flex Spending options
• Adoption assistance
• Tuition reimbursement
• Leverage Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
• Gym, fitness facility and cell phone discounts
• Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.

GUIDING PRINCIPLES:
Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled

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Posted 7/25/2024

SR. MANAGER, COMPLIANCE - Intra-Cellular Therapies
Department: Compliance
Location: Hybrid- Bedminster, NJ US
FLSA Status: Exempt

About the Role:
This role will report directly to the Executive Director, Compliance with a dotted line to the Director, Transparency and Monitoring. The Sr. Manager will be responsible for developing, implementing, and maintaining various aspects of the Compliance Program including training, policy, monitoring, auditing, HCP engagements, communications, investigations, and corrective action. The Sr. Manager will also focus on partnership with home office and field stakeholders in support of Business and Compliance functions. This is a hybrid position with expectation of attendance in the office twice a week.

Job Responsibilities

• Develop, update, and implement compliance policies and procedures, including Code of Conduct.
• Training, Education and Communications: Lead the Compliance training, education, and communications program. Develop, implement, and execute all aspects of compliance training program including new hire onboarding training. Partner with Sales Training and the LMS Training Department to ensure appropriate and effective training and education across the organization. Responsible for Compliance communications including the development of content, newsletters, and maintain the Compliance website.
• Investigations: Manage internal compliance investigations and coordinate appropriate follow up actions as needed. Enforce compliance standards in partnership with key stakeholders including HR and legal. Manage the Compliance Departments Whistleblower Line and follow up.
• Monitoring and Auditing: Implement effective auditing and monitoring programs and processes to ensure effectiveness of overall compliance programs; inclusive of policies and procedures, trainings, investigations, and other compliance initiatives. Manage the Compliance Department's Incident Management Tool and all follow up.
• Risk Management: Support all risk mitigation and enhancement processes and plans. Develop risk assessment protocols for ongoing review.
• HCP Engagements: Oversee ITCI's HCP Engagement and FMV process. Partner with Finance and Legal to ensure appropriate contracting and finance controls are also met with respect to HCP engagements.
• Project Management: Identify and lead strategic projects designed to fulfill the needs of and enhance the effectiveness of the ITCI Compliance Program. Drive results-oriented process improvement.
• Other Duties: Assist the Compliance Team and CCO with the preparation of reports, summaries, and documentation for internal and/or external use and other duties as assigned.

Job Requirements

• Bachelor's degree required from an accredited college or university.
• Minimum 5-7+ years of compliance, monitoring, auditing, project management and other relevant experience within the pharmaceutical or life sciences industry.
• Working knowledge of the legal and regulatory environment within the pharmaceutical or life sciences industry.
• Ability to successful work with team and partner with internal cross-functional teams.
• Strong analytical, organizational, problem-solving, and follow up skills required.
• Ability to communicate effectively with individuals at all levels, internally and externally.
• Proactive, self-starter with a strong sense of ownership and accountability.
• Keen attention to detail.
• Demonstrated proficiency with Microsoft Office suite, including Excel, Word, and PowerPoint; Internet, or other systems tracking software.
• Hands on experience supporting a learning management system.
• Complete all company and job-related training as assigned within the required timelines
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice
• Must be able to perform all essential functions of the position, with or without reasonable accommodation.

Intra-Cellular Therapies is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability, or any other legally protected status.

 Apply here
Posted 7/19/2024

COMMERCIAL COUNSEL - SpringWorks Therapeutics
Location: Stamford, CT US/ Hybrid or United States (Remote)

About SpringWorks Therapeutics::
SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.

SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.

SpringWorks Leadership Principles:

• Change Steward - Recognize that change is essential; set goals that align to the Company's strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever changing requirements
• Excellence Driver - Drive high performance and ownership through an open dialog; recognize performance, empower teams and create accountability for results
• Growth Coach - Set clear expectations, provide frequent feedback, coaching, and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers
• Community Builder - Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse, inclusive, and psychologically safe environment

About the Role::
SpringWorks is looking for an experienced attorney to join its in-house legal function and serve as commercial counsel under the direction of the lead commercial attorney. The individual will act as the legal point person for one of SpringWorks' brand teams as well as provide support for cross-brand activities and should possess experience providing practical, sound, and high-quality legal advice on biopharmaceutical commercialization activities from pre-launch planning throughout the product life cycle.

The individual will serve as the legal reviewer for review of promotional and medical affairs materials and support commercial contracting needs, acting as a strategic business partner to the Commercial and Medical functions and collaborating with other key functions (e.g., functions supporting commercialization, Legal / Compliance colleagues, and outside law firms) to further the Legal Department's efforts to promote an environment and culture of integrity, business partnership, problem solving and risk mitigation. This individual must be able to thrive in a dynamic and fast-paced environment and work as an integral member of the team.

Key Responsibilities:

• Provide legal counsel regarding laws applicable to pharmaceutical promotion and sales (including the Food, Drug, and Cosmetic Act, FDA regulations, federal fraud and abuse laws, privacy laws, regulatory agency guidance, industry codes).
• Legal representative on the cross-functional Medical, Legal and Regulatory review committee.
• Advise on promotional materials, disease awareness materials, dissemination of scientific communications, field sales training, social media initiatives, patient services, and product labeling.
• Draft, review, negotiate contracts that support ongoing commercialization and other business operations.
• Develop and maintain expertise in applicable laws and regulations regarding commercialization of pharmaceutical products.
• Perform other duties and responsibilities as assigned.

Qualifications:

• Education: JD degree from an ABA-accredited law school with strong academic credentials.
• 7+ years in the biopharmaceutical/life sciences department of a leading law firm and/or an in-house legal department of a commercial-stage pharmaceutical corporation.
• Active member of a state bar and in good standing.
• Knowledge of healthcare laws and regulations applicable to discounts and pricing, federal and state anti-kickback statutes, state drug price transparency laws, as well as the Food, Drug & Cosmetic Act and FDA regulations and guidance.
• Skilled in drafting and negotiating a variety of agreements; ability to draft concise and effective contractual documents.
• Must possess a strong sense of ownership and responsibility, as well as a proven work ethic delivering excellent work product.
• Exhibits excellent judgement, is a self-starter, has high integrity, and is solution oriented with a collaborative approach.
• Able to work independently and under time constraints in a fast-paced and dynamic environment.
• Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams' performance.
• Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
• Ability to travel occasionally including overnight stay driven by business need.
• This position must be able to work East Coast hours. #LI-Remote

Compensation:
The expected salary range for this position is $185,000 – $240,000. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

We also offer a comprehensive benefits package for our team of SpringWorkers and their families, including competitive compensation, annual cash bonuses and equity grants, 401K matching, fully covered medical, dental, and vision plans, and a full week of holiday break at year end. It's the right thing to do – and helps us be healthy, happy, and at our best for the people who need us.

Commitment to Diversity, Equity, and Inclusion:
At SpringWorks, we believe in fostering a culture of belonging. Our Employee Resource Group's (ERG) mission is to boldly live the SpringWorks values, provide resources, and deeply engage SpringWorkers and the communities we serve to foster a culture of belonging. Ensuring diversity, equity, and inclusion are integral to our organization's DNA.

EEO Statement:
SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks' Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.

This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.

 Apply here
Posted 7/16/2024

ASSOCIATE DIRECTOR COMPLIANCE MONITORING AND RISK MANAGEMENT - Incyte Pharmaceuticals
Location: Wilmington, DE US
Full Time
Job Requisition ID: 4484

Background:
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary Function):
This position reports to the Senior Director, Compliance Monitoring, Risk, and Investigations and is responsible for leading Compliance monitoring activities, developing, and tracking corrective and preventative action plans related to compliance issues, and managing risk assessments. The position will also support other Compliance responsibilities including those related to investigations; training; communications; aggregate spend; and special projects. The role is located at Incyte's global headquarters.

Essential Functions of the Job (Key Responsibilities):

• Development and communication of annual plans for monitoring activities based on risk assessments, results of current and prior monitoring activities, outcomes from investigations, and other sources including regulatory and enforcement updates and trends.
• Provide assignments to internal and external monitoring resources and conduct live, transactional, and analytical monitoring ensuring fulfillment of annual commitments.
• Develop and track corrective and preventative action plans related to confirmed compliance issues.
• Develop and maintain dashboards and metrics that accurately report on planned versus actual monitoring status, issues, and the status of corrective and preventative action plans.
• Conduct analysis to understand factors contributing to potential policy violations, develop recommendations and assist with the design of controls and standards for identified gaps in monitoring activities.
• Work closely with the Compliance Business Leads to ensure that monitoring activities continuously align to identified risk areas, adhere to the approved sample selection criteria, and are executed in a consistent manner.
• Manage the compliance monitoring system through accurate configuration and data capture, drafting business requirements, performing user acceptance testing, and assisting in the development of presentations using the system's dashboards and metrics.
• Lead the development and execution of compliance analytics that identify trends, patterns or outliers that help drive risk-based actions and decisions.
• Manage the Incyte Compliance Risk Assessment processes within the established timelines. This includes engaging Compliance, Legal and Business stakeholders, preparing reports of Risk Assessment results, and tracking and reporting on mitigation actions.
• Support the Compliance Investigation process through focused transactional monitoring and other assigned research.
• Support additional compliance initiatives and projects.

Qualifications (Minimal acceptable level of education, work experience, and competency):

• BA/BS degree required.
• 5-7 years of compliance, risk management or relevant bio/pharmaceutical industry experience.
• Knowledge of compliance laws, regulations, and industry guidelines.
• Experience independently planning and conducting complex and sensitive monitoring, including data analysis.
• Attention to detail and focus on quality work product.
• Ability to manage and prioritize projects under tight deadlines.
• Excellent written, oral communication, interpersonal, and organizational skills.
• Strong analytical, investigative, and problem-solving skills
• Solution-oriented, team focused and strong technical skills including knowledge and experience using Microsoft applications (Excel, Word, and PowerPoint)
• Ability to travel 25-35%.
• Experience in compliance solutions for data analytics, monitoring and risk management preferred.

Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: www.incyte.com/privacy-policy.

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.

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Posted 7/2/2024