The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

ASSOCIATE DIRECTOR, MEDICAL AND CLINICAL COMPLIANCE - Ferring Pharmaceuticals
Location: Parsippany, NJ

Job Description:
Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with approximately 6,500 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of Reproductive Health (Infertility), Urology, Gastroenterology, Endocrinology, Women's Health (Obstetrics/Gynecology), Orthopedics, and Oncology. Ferring's US operations employ approximately 900 people.

People Come First at Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.

Summary:
The Associate Director for Medical & Clinical Compliance will serve as the compliance lead to the Research, Clinical Development and Medical Affairs Departments. The Associate Director is responsible for created a risk-based compliance strategy, providing compliance direction and, training, in support of the organizations' medical affairs and clinical development related activities A key purpose is to ensure adherence with applicable Company policies and procedures as well as industry standards and best practices. Associate Director will act as the compliance leads for all medical and clinical initiatives from concept to implementation, including support of Medical Directors, Medical Science Liaisons (MSLs)/Outcomes Liaisons (OLs). Role will coordinate and draw on resources from other functions including the broader Compliance Department, and particularly other senior leaders in that function.

Responsibilities:

  • Provide sound compliance advice and guidance on non-promotional materials, scientific exchange, disease state, regulatory, medical/scientific programs and R&D activities to minimize company risk and facilitate compliance in alignment with applicable regulations.
  • Develop and execute an engagement and integration plan for US Compliance to incorporate requirements and training into all client groups, and vendors, involved with medical and scientific operations.
  • Create, implement and monitor an operational and effective compliance program for policies and procedures in a manner consistent with best practices and applicable laws and guidance.
  • Partner with the business support teams, including Legal, Regulatory, and Human Resources, to establish Compliance requirements and guidelines in support of non-commercial employees.
  • Provide input on Compliance matters to present to key stakeholders and senior leadership.
  • Foster a Company culture that focuses on Compliance and ensures on-going commitment to the Ferring Philosophy.
  • Develop and maintain SOPs, guidelines, policies and associated internal communication related to non-promotional, medical/clinical programs, including congress activity, clinical symposium, publications, reprints, medical information, advisory boards, ad hoc consulting, IITs, CTs, Mock FDA meetings, etc.
  • Liaise with Ferring Research facilities as well as Global non-commercial departments to ensure transparence and disclosure reporting and other relevant Compliance policies and processes are being communicated and being adhered.
  • Represent Compliance as the primary point of contact for the evaluation and implementation of SOPs and policies with Compliance impact and contribute to related standards and guidelines for the review of concepts and activities based on identified gap analyses and risks assessments or potential areas of Compliance vulnerability.
  • Act as the Compliance lead with all Medical, Scientific, Research and Development activities, including MSLs; from concept to field implementation and act as the primary Compliance authority on Corporate Contributions, Ed Grants, IITs, Delayed Publication, FIPCUS QA Committees other non-promotional Medical related and scientific team meetings.

Requirements:

  • 6+ years of pharmaceutical industry experience, with Compliance, Legal, Medical, or equivalent experience preferred
  • Bachelor's degree required
  • In depth understanding of PhRMA Code; Federal Food, Drug, Cosmetic Act; Anti-Kickback Statute; and federal and state transparency and disclosure laws.
  • Strong knowledge of industry compliance activities, regulatory landscape, pharmaceutical compliance training and monitoring programs.
  • Demonstrated experience and creating and delivering effective compliance training
  • Strong interpersonal skills, platform skills, and written and verbal communication skills
  • Experience involving the implementation of risked-based compliance programs and understanding of US pharmaceutical and other regulations.
  • Works well across multiple functions and therapeutic areas
  • Demonstrated ability to develop, launch, deliver, and measure various forms of training.
  • Proficient technology skills, etc.
  • Position requires excellent written and verbal communication, motivational, interpersonal and time management skills
  • Travel 20-30%

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

If you need assistance during the application process due to a disability, please email careers@ferring.com.

 Apply here
Posted 9/12/2019

ASSOCIATE DIRECTOR, PRIVACY - Ferring Pharmaceuticals
Location: Parsippany, NJ

Job Description:
Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with approximately 6,500 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women's health (obstetrics/gynecology), orthopedics and Oncology. Ferring's US operations employ approximately 900 people.

People Come First at Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.

Responsibilities:

  • Develop and implement the Ferring Privacy program in the United States aligning with the overall Ferring Group Privacy Program and ensuring adherence with privacy legislation globally as well as applicable data protection laws, regulations and guidelines.
  • Developing and reviewing content for training materials, guidance documents and other communications to increase employee understanding of company privacy policies, data handling practices and legal obligations, as well as to ensure awareness of company privacy and data security issues via global and local communications plans.
  • Performing regular privacy assessments of business processes, providing practical and timely advice to internal clients to design processes in compliance with applicable data protection requirements, while protecting the company's integrity and reputation.
  • Managing process for responding to data subject requests and reports of potential data incidents (in compliance with Privacy Counsel and Litigation).
  • Overseeing monitoring/auditing plan for compliance with internal data protection policies and processes and working with Internal Audit function, Office of Business Integrity and Ethics or external auditors in carrying out plan.
  • Keeping abreast of privacy developments affecting clients (e.g., evolving guidance out of the European Union, California Privacy Act, discussions of US privacy laws, CAN-SPAM and e-privacy developments) and proactively anticipating potential changes needed to global privacy program to meet new regulatory requirements.
  • Develop and maintain standard operating procedures, guidelines, and policies in U.S. related to key areas of vulnerability within privacy and data protection.
  • Establish and facilitate activities to engage, educate, train, and inform U.S. organization about privacy issues, policies, and controls.
  • Performing regular privacy assessments of business processes, providing practical and timely advice to internal clients to design processes in compliance with applicable data protection requirements, while protecting the company's integrity and reputation.
  • Managing process for responding to data subject requests and reports of potential data incidents (in compliance with Privacy Counsel and Litigation).

Requirements:

  • Bachelor's degree required. Advanced degree or other privacy certification preferred;
  • Minimum of 5 years' experience providing privacy or related advice such as compliance, regulatory or IT, preferably to pharmaceutical, biotechnology, or medical device companies; legal background preferred but not required;
  • In-depth understanding of pharmaceutical compliance and privacy state laws.
  • Extensive knowledge of U.S. privacy and data breach laws and international privacy/data protection regulations. GDPR
  • Ability to effectively work across multiple functions/therapeutic areas;
  • Proficient computer skills: Word, Excel, Lotus Notes, Power Point, etc.
  • Position requires maturity, excellent communication (verbal/written) and presentation skills;
  • Certified Information Privacy Professional (CIPP), Certified Information Privacy Manager (CIPM), or equivalent professional

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

If you need assistance during the application process due to a disability, please email careers@ferring.com.

 Apply here
Posted 9/12/2019

ASSOCIATE DIRECTOR, COMPLIANCE MONITORING & AUDITING - Jazz Pharmaceuticals
Category: Corporate
Country: United States
State: Pennsylvania
City: Philadelphia
Or may be based in Palo Alto, CA
Type: Regular Full Time
Job ID: 4504

Overview:
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.

Responsibilities:
The Associate Director, Compliance Monitoring & Auditing is responsible for developing and executing against the Jazz Pharmaceuticals, Inc. (Jazz) annual compliance monitoring plan. This position will regularly monitor field activities, conduct monitoring and audits of company records and programs, execute against Jazz's Risk Assessment and Mitigation Process (RAMP) program, and have responsibility for remediation activities related to compliance findings and allegations of non-compliance with Company policy. The position will prepare dashboards, reports, and presentations summarizing monitoring and auditing findings and remediation for audiences ranging from Business Partners to Jazz Leadership.

Primary Responsibilities:

  • Develops and manages the annual compliance monitoring plan.
  • 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, and consulting and advisory engagements.
  • Prepares reports, presentations, and dashboards for numerous audiences, including Jazz Leadership, that summarize monitoring and auditing findings and remediation.
  • Supports Jazz's RAMP process and prioritizes monitoring activities and mitigation plans based on potential risks associated with Jazz's products and with applicable Federal health care program requirements.
  • Manages the remediation and corrective action process for the Compliance team.
  • Conducts ad-hoc monitoring and auditing as necessitated by investigations and Jazz's Corporate Integrity Agreement.
  • Supports the development and enhancement of 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 by the Corporate Integrity Agreement, Open Payments, and state law monitoring and reporting.
  • Develops and maintains updated knowledge and understanding of Jazz's products, industry regulations and guidelines, and Company policies and standard operating procedures.
Required Knowledge, Skills, and Experience:

  • Minimum of 5 years' of healthcare compliance monitoring or auditing experience with a pharmaceutical/biopharmaceutical company or within the life sciences industry is required.
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, HIPAA, Open Payments, and relevant industry guidance, specifically PhRMA Code on Interactions with Healthcare Professionals is required.
  • Experience working under a Corporate Integrity Agreement is preferred.
  • Ability to manage multiple projects to completion on-time, meeting internal and external deliverables with high degree of accuracy.
  • Ability to interact with Jazz 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.
  • Position may be based in Philadelphia, PA or Palo Alto, CA.
Required/Preferred Education:

  • Bachelor's degree required.
Description of Physical Demands:

  • Position requires regular travel within the United States (estimated at ~40% per year);
  • Participation in ride-alongs' with field employees: one full day to multiple consecutive days;
  • Travel to participate at promotional programs: one hour to full day of attendance;
  • Travel to participate at external Conference, Congresses, and Industry events for 1-4 day periods;
  • Travel to Palo Alto office if needed to meet with business colleagues.
Description of Work Environment:

  • Work will be split between an office-based environment (~60%) and a field-based environment (~40%):
    • Work indoors will be in a normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes
    • Work outdoors will require flight travel, overnight lodging, and extended period of time in a car
  • Frequent computer use in the field and office;
  • Responsibilities will require a work schedule that includes working outside of "normal" work hours while traveling in order to meet business demands;
  • Given the nature of work performed by the Compliance Department, Associate Director, Monitoring & Auditing may be asked to temporarily support other compliance related activities (e.g. CIA, compliance investigation(s), etc.) when necessary to meet a compliance obligation or firm [e.g. Government] deadline.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

 Apply here
Posted 9/10/2019

ETHICS AND COMPLIANCE PARTNER - UCB, Inc.
Location: Atlanta, Georgia

To strengthen our Ethics & Compliance team, we are looking for an Ethics & Compliance Partner

Are you an Ethics & Compliance expert looking to make an impact on the lives of patients?

As an Ethics & Compliance Partner you will work in an environment where you will:


Be the front-line representative of E&C organization, and represent E&C in a responsible and professional manner while acting as a strategic business partner.

This role is responsible for providing subject matter expertise and leadership on compliance-related matters within the organization, ensuring that the supported Patient Value organization is educated on Ethics & Compliance standards, informed about Ethics & Compliance related risks, helping minimize those, building Ethics & Compliance by design in their initiatives and guiding their personnel through global processes, connecting them with local stakeholders as needed.

This role will be responsible to oversee regional initiatives and connect with local Ethics & Compliance colleagues, ensuring appropriate flow of information; connecting with E&C peers through formal and informal collaboration networks to ensure consistent application of E&C approaches and efficient sharing of best practices.

As the Ethics & Compliance Partner you will contribute by:

  • Maintaining thorough knowledge of all industry codes, laws, regulations, and monitor key developments that would impact the business. In collaboration with colleagues, advise the business regarding existing and future provisions. For future provisions, ensure appropriate planning and preparation where it will impact the business.
  • Drive risk assessments for compliance in the supported organization, informed by adequate monitoring and analytics, ensuring that key stakeholders are informed on relevant risks and implementing remediation plans, in collaboration with E&C Leadership.
  • Supporting development of Policies and Procedures as a subject matter expert.
  • Working with the relevant stakeholders to ensure regional organizations are educated and well informed about ethics & compliance policies and procedures.
  • Acting as a proactive strategic partner with the business to help them meet their goals and objectives in a compliant manner, analyzing alternatives and proposing solutions.
  • Co-creating and collaborating on business initiatives to foster innovation and creation of meaningful solutions for patients while ensuring integrity and ethical principles are respected.
  • Actively engaging the supported organization leadership in driving the tone in integrity from the top and leveraging communication cascaded to the organization to maintain a high level of awareness in ethical business conduct.
Key Stakeholders:

  • Patient Value Units Regional and Missions' teams
  • Patient Value Practices teams
  • PVU/PVP Legal Counsels, Talent and Finance Partners
  • Ethics & Compliance Area/Affiliate teams
  • Ethics & Compliance PVU/PVP partners and Regional Head
Competencies & Proficiency:

  • Demonstrates curiosity and interest in the knowledge and experiences of colleagues.
  • Takes accountability for trying out new ideas and approaches.
  • Identifies and raises potential delays in project planning, plus their associated risks.
  • Builds, integrates and controls project planning, scheduling and resources.
  • Effectively communicates with local and regional stakeholders to have an aligned and approved project plan.
  • Propose ways of improvement in building and controlling project plans, in terms of accuracy and compliance risks.
  • Demonstrates and encourages generosity and helpfulness by sharing knowledge, skills and resources to optimize and improve outcomes.
  • Experience working in and being comfortable with matrix organization and reporting lines, and cross-functional teams without clear single leadership.
Interested? For this position you'll need the following education, experience and skills:

  • Bachelor's Degree/Master's Degree preferred
  • Minimum of 3 years of experience in the pharmaceutical industry.
  • Experience (direct or indirect - confronted and operated) in healthcare compliance.
  • Proficiency in Healthcare Compliance rules and regulations including self-regulated industry codes (PhRMA).
  • Experience in a transnational and multicultural environment.
  • Work effectively to design policies, management documents, presentations, control databases, KPI's, and dashboards.
 Apply here
Posted 8/30/2019

SENIOR DIRECTOR, US LEAD, ETHICS & COMPLIANCE - Alnylam Pharmaceuticals
Location: Based in Cambridge, MA

Alnylam was founded in 2002 on a revolutionary vision and bold mission that remain firmly in place today. We are leading the translation of RNAi as a new class of medicines with a core focus on RNAi therapeutics. Our research focuses on genetically defined targets for the treatment of serious, life-threatening diseases with limited treatment options for patients and their caregivers. In January 2015, we announced our "Alnylam 2020" guidance that reflects our expected transition from a late-stage clinical development company to a multi-product commercial-stage company with a sustainable development pipeline. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work in 2015-2018.

Reporting to the VP, Global Head, Ethics and Compliance in Cambridge, MA, and partnering closely with the Regional Lead, US Business and US Regional Medical Affairs, the Senior Director, US Lead, Ethics & Compliance will lead the design, implementation, and enhancement of an effective global ethics and compliance program for Alnylam's US Business. The Senior Director will work closely with other Ethics & Compliance colleagues, and with Legal, Regulatory and other business colleagues to ensure employee adherence to the Company's Code of Conduct and related rules, policies, and procedures.

The Senior Director will be a member of the US Management Team, expected to actively participate and contribute to US Regional Management, and will partner closely with business colleagues across the Company to sustain Alnylam's strong ethical culture. In particular, the Senior Director must

  • Establish a collaborative and proactive partnership with the Legal team and the regional and local management in the US Business and Medical Affairs, and
  • Represent regional needs and requirements within the Global Ethics and Compliance team and make sure that local requirements are appropriately addressed in any Global or Regional policies
Responsibilities

  • Work alongside employees and company leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem solving
  • Advise the Head of the US Business and his Leadership Team, as well as the US Medical Affairs team, regarding Compliance obligations and continue to evolve the US Region's current compliance program and ensure that it is consistent with the values and principles of the organization, fit for purpose and complies with regulatory requirements
  • Develop and implement a tailored regional governance framework including, if appropriate, a US compliance committee for oversight of the regional compliance program
  • Draft and implement appropriate policies, in collaboration with Legal and other Ethics & Compliance colleagues, to ensure compliance with applicable laws, regulations and codes applicable in multiple countries (excluding cGMP, cGCP and other GXP guidelines)
  • Support the implementation and continued adherence to US transparency reporting requirements and assist business leadership in meeting reporting obligations
  • Work with US Regional leadership on the implementation of a robust privacy program and on adherence to US privacy laws
  • Assist in implementation and execution of risk based third party due diligence
  • Execute compliance risk assessments periodically, at least annually, and create and oversee appropriate improvement plans to mitigate risk appropriately, in a tailored and prioritized manner.
  • Prepare and deliver compliance training and education to the US Regional organization to ensure understanding of employee responsibilities and ethics and compliance issues, as well as related policies and procedures
  • Design and execute routine and risk based monitoring and auditing of relevant business activities and related policies and procedures; assist in and oversee the implementation of corrective action plans as necessary; and generate and deliver reports to leadership on monitoring, auditing and risk assessment.
  • Conduct or assist in investigations into reported compliance concerns or any allegations of misconduct, as required
  • Travel required
  • Other responsibilities as may be assigned from time to time in the company's discretion
Education, Experience & Skills

  • Legal degree strongly preferred, other relevant accreditations or degrees considered
  • Minimum of 10 years of ethics, compliance or a mix of compliance and legal experience in an organization subject to global biopharmaceutical, medical device or other relevant healthcare compliance laws and regulations, preferably in rare diseases
  • Demonstrated ability to work cross-functionally and collaboratively with US and ex-US personnel
  • Experience with transparency reporting requirements and systems
  • Knowledge of laws and regulations applicable to global pharmaceutical companies, including among other things, the Foreign Corrupt Practices Act, US fraud and abuse and false claims laws, and PhRMA Code on Interactions with Healthcare Professionals.
  • Must be able to work collaboratively in a team environment with a wide variety of company personnel on a broad range of matters, including physicians, scientists and individuals of different nationalities. People management experience strongly preferred
  • Ability to manage multiple tasks simultaneously, to work independently and manage discrete areas of responsibility with little direct supervision, and to flourish in a fast-paced and high stress environment
  • Able to thrive in a proactive ethical culture in which compliance and business objectives are mutually reinforcing; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the Company's business and culture
  • Excellent organization, communication (verbal and written) with fluency in written and spoken English required, and prioritization skills, including the ability to communicate concisely Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

 Apply here
Posted 8/12/2019

MANAGER, ETHICS AND COMPLIANCE - Alnylam Pharmaceuticals
Location: Based in Cambridge, MA

Reporting to the Global Head, Ethics and Compliance in Cambridge, MA, the Manager, Ethics and Compliance will support the implementation, and enhancement of an effective global ethics and compliance program. The Manager will work closely with other members of the Ethics & Compliance team and with colleagues in the Legal group and throughout the company to ensure employee adherence to the Company's Code of Business Conduct and related rules, policies, and procedures.

Responsibilities

  • Partner with employees and company leadership to maintain and further develop a strong culture of ethics and compliance throughout the organization, including personal accountability at all levels in the organization
  • Assist in maintaining and amending policies to ensure compliance with applicable laws, including, specifically, healthcare, anti-corruption/anti-bribery, antitrust/competition, global transparency reporting, global privacy, and anti-fraud laws, and global regulatory authority guidance for biopharmaceutical companies (excluding cGMP, cGCP and other GXP guidelines)
  • Assist in preparation and delivery of training and education and in deployment of regular and meaningful compliance communications to the organization to ensure understanding of employee responsibilities and ethics and compliance issues, as well as related policies and procedures
  • Execute risk based routine monitoring and auditing of relevant global business activities and related policies and procedures and follow up on any necessary improvements and support regional monitoring and auditing efforts. Maintain internal systems to capture monitoring plan, monitoring results, and remediation
  • Support Alnylam's global aggregate spend reporting process and system for US, and ex-US reporting, including data collection, aggregation and reporting processes, issue documentation and resolution, and training
  • Using transparency system data and other data sources, support assessment and reporting on compliance related issues, trends and risks
  • Some travel required
  • Other responsibilities as may be assigned from time to time at the company's discretion
Education, Experience & Skills

  • Bachelor's Degree required. Other relevant accreditations or degrees considered and a plus
  • Prior ethics, compliance or a combination of compliance and legal experience in an organization subject to US biopharmaceutical, medical device or other relevant healthcare compliance laws and regulations required
  • International biopharmaceutical compliance experience a plus
  • Must be able to work cooperatively in a team environment with a wide variety of company personnel on a broad range of matters, including physicians, scientists and individuals of different nationalities
  • Ability to manage multiple tasks simultaneously and to flourish in a fast-paced environment.
  • Able and eager to work independently and to prioritize multiple commitments. Demonstrated ability to timely deliver on commitments
  • Able to thrive in a proactive ethical culture in which compliance and business objectives are mutually reinforcing; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the Company's business and culture
  • Excellent organization, communication (verbal and written - fluency in spoken and written English required) and prioritization skills, including the ability to communicate concisely, to integrate legal and business considerations, and to provide balanced, solution oriented guidance
 Apply here
Posted 8/12/2019

SENIOR MANAGER, PRIVACY AND ETHICS & COMPLIANCE - Alnylam Pharmaceuticals
Location: Based in Cambridge, MA

Alnylam was founded in 2002 on a revolutionary vision and bold mission that remain firmly in place today. We are leading the translation of RNAi as a new class of medicines with a core focus on RNAi therapeutics. Our research focuses on genetically defined targets for the treatment of serious, life-threatening diseases with limited treatment options for patients and their caregivers. In January 2015, we announced our "Alnylam 2020" guidance that reflects our expected transition from a late-stage clinical development company to a multi-product commercial-stage company with a sustainable development pipeline. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work in 2015-2018.

Reporting to the Director, Ethics and Compliance in Cambridge, MA, the Senior Manager, Privacy and Ethics & Compliance will support the design, implementation, and enhancement of an effective data privacy and global ethics and compliance program. The Senior Manager will work closely with other Ethics & Compliance colleagues, and with Legal, Human Resources, Information Technology and other business colleagues to ensure employee adherence to the Company's Privacy program principles and our Code of Business Conduct and Ethics and related rules, policies, and procedures.

The Senior Manager will be expected to partner closely with business colleagues across the Company to sustain Alnylam's strong ethical culture.

Responsibilities

  • Be a privacy expert to internal teams and guide teams in designing privacy-respecting policies, processes, and solutions. Educate teams about privacy and data protection and privacy by design/default
  • Assess complex privacy inquiries and collaborate with cross-functional teams to respond concisely and provide high-quality support and timely solutions
  • Develop and maintain internal processes and documentation for privacy/data protection related inquiries, incidents, initiatives and activities
  • Create and disseminate clear reports on privacy program and privacy metrics tailored to different stakeholders
  • Partner with Alnylam's IT Security and other teams to evaluate new products, features, and processes. Work with Expertise Areas to pull through privacy initiatives and track and report on deliverables and action items. Work cross-functionally with stakeholders across the company worldwide to drive continuous improvements
  • Partner with employees and company leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization
  • Prepare and deliver training and education to the organization to ensure understanding of employee responsibilities and ethics and compliance and privacy issues, as well as related policies and procedures
  • Other responsibilities as may be assigned from time to time in the company's discretion
Education, Experience & Skills

  • Bachelor's Degree required. Juris Doctor and privacy accreditation strongly preferred, other relevant accreditations or degrees considered
  • Minimum of 5 years of privacy, ethics, compliance and/or legal experience in an organization subject to biopharmaceutical, medical device or other relevant healthcare compliance laws and regulations, or in a law firm or consultancy firm advising the biopharmaceutical industry. Privacy experience in another regulated industry considered.
  • International privacy experience a plus. Must be familiar with privacy laws and regulations in countries globally. Prior experience responding to privacy-related questions and rights requests preferred
  • Must be able to work cooperatively in a team environment with a wide variety of company personnel on a broad range of matters, including physicians, scientists and individuals of different nationalities
  • Ability to manage multiple tasks simultaneously and to flourish in a fast-paced and demanding environment while maintaining a positive attitude and sense of humor.
  • Able and eager to work independently and possess situational awareness to identify and escalate matters that require attention
  • Able to thrive in a proactive ethical culture in which compliance and business objectives are mutually reinforcing; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the Company's business and culture
  • Excellent organization, communication (verbal and written - fluency in English required) and prioritization skills, including the ability to communicate concisely, to integrate legal and business considerations, and to provide balanced advice regarding risks
  • Proficiency in Microsoft and the Google suites of applications in a business environment
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

 Apply here
Posted 8/12/2019

ASSOCIATE DIRECTOR, ETHICS & COMPLIANCE, US REGION - Alnylam Pharmaceuticals
Location: Based in Cambridge, MA

Alnylam was founded in 2002 on a revolutionary vision and bold mission that remain firmly in place today. We are leading the translation of RNAi as a new class of medicines with a core focus on RNAi therapeutics. Our research focuses on genetically defined targets for the treatment of serious, life-threatening diseases with limited treatment options for patients and their caregivers. In January 2015, we announced our "Alnylam 2020" guidance that reflects our expected transition from a late-stage clinical development company to a multi-product commercial-stage company with a sustainable development pipeline. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work in 2015-2018.

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

Responsibilities

  • Partner with employees and leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization with a spirit of partnership and positive problem solving
  • Assist to evolve the compliance program within the US Region and ensure that it is consistent with the values and principles of the organization, fit for purpose and complies with applicable requirements
  • Draft and/or update appropriate policies to ensure compliance with applicable laws, regulations and industry codes and alignment with global policies
  • Support the implementation and maintenance of US federal and state transparency reporting requirements and assist business leadership in meeting reporting obligations
  • Assist in implementation and execution of risk based third party due diligence
  • Support the implementation of a robust privacy program and help pull through privacy requirements within the US Business
  • Prepare and deliver training and education to ensure understanding of employee responsibilities and ethics and compliance issues, as well as related policies and procedures
  • Execute routine and risk based monitoring and auditing of relevant US Business activities and related policies and procedures; identify potential areas of compliance vulnerability and risk; assist in and oversee the implementation of corrective action plans as necessary; and generate reports on monitoring, auditing and risk assessment for the US Business
  • Travel required
  • Other responsibilities as may be assigned from time to time in the company's discretion
Education, Experience & Skills

  • Bachelor's Degree required. Juris Doctor strongly preferred, other relevant accreditations or degrees considered
  • Minimum of 7 years of ethics, compliance and/or legal experience in an organization subject to US biopharmaceutical, medical device or other relevant healthcare compliance laws and regulations
  • Demonstrated ability to work collaboratively and cross-functionally in a team environment with a wide variety of company personnel on a broad range of matters
  • Ability to manage multiple tasks simultaneously and to flourish in a fast-paced and high energy environment
  • Able and eager to work independently and to manage and oversee discrete areas of responsibility with little direct supervision
  • Able to thrive in a proactive ethical culture in which compliance and business objectives are mutually reinforcing; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the Company's business and culture
  • Excellent organization, communication (verbal and written - fluency in English required) and prioritization skills, including the ability to communicate concisely, to integrate legal and business considerations, and to provide balanced advice regarding risks
  • Experience with privacy and transparency reporting a plus
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

 Apply here
Posted 8/12/2019

COMPLIANCE COUNSEL - Neurocrine Biosciences
Location: San Diego, CA

WHO WE ARE: At Neurocrine Biosciences - voted one of San Diego's top places to work in 2018 - we pride ourselves on having a strong, distinctive and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve patient suffering and enhance lives.

WHAT WE DO: Neurocrine Biosciences is a biopharmaceutical company focused on developing treatments for neurological and endocrine related disorders.

ABOUT THE ROLE: The Compliance Counsel reports to the Chief Compliance Officer and will be responsible for assisting in the execution and continuous improvement of the Neurocrine Compliance and Ethics program to ensure compliance with all applicable laws and regulations.

YOUR CONTRIBUTIONS (include, but are not limited to):

  • Provide sound compliance guidance to employees of Neurocrine, consistent with applicable laws, regulations and Neurocrine policies
  • Conduct and manage compliance investigations regarding allegations of potential violations of law or company policy and/or ethical standards, prepare reports on the results of the investigations, and assist with the determination and implementation of corrective actions
  • Conduct monitoring and auditing to ensure compliance with applicable laws, regulations and Neurocrine policies, including field rides, speaker programs and advisory boards
  • Analyze monitoring and auditing results to recommend improvements in compliance or business operations
  • Assess compliance training needs, develop and deliver effective and creative training, including written materials, computer-based training and live presentations
  • Provide compliance input and expertise into business decisions, including development of solutions-orientated risk mitigation strategies
  • Perform other duties as assigned/requested

REQUIREMENTS:

  • BA/BS and JD required 3+ years of experience in the biotech/pharmaceutical or medical device industry
  • In depth understanding of the Anti-Kickback Statute, the False Claims Act, Federal Food, Drug, Cosmetic Act; PhRMA Code; OIG Seven Elements; HIPAA; and federal and state transparency and disclosure laws
  • Strong knowledge of industry compliance best practices, regulatory landscape, and pharmaceutical compliance training and monitoring programs
  • Excellent verbal and written communications skills; must be an effective communicator with strong interpersonal skills
  • Ability to establish and maintain relationships across multiple corporate functions
  • Adaptable and flexible, able to prioritize duties and manage multiple matters from start to finish with minimal supervision

WORKING CONDITIONS:
Office based in San Diego, CA, approximately 30% domestic travel.

Visit the Neurocrine Careers website at https://www.neurocrine.com/careers/overview/.

Neurocrine Biosciences is an EEO/AA/Disability/Vets Employer
 Apply here
Posted 8/7/2019

MANAGER, AGGREGATE SPEND / TRANSPARENCY - Esperion Therapeutics
Location: This can be a remote position anywhere in the US.

Company Overview:
Esperion is a small company doing big things. Our innovative team of lipid management experts is committed to leveraging its understanding of cholesterol biosynthesis to develop innovative therapies for the treatment of patients with elevated low-density lipoprotein (LDL-C). At Esperion we are passionately committed to bringing complementary therapies to the hypercholesterolemia space that address unmet patient needs in a way that is "patient-friendly, physician-friendly and payer-friendly."

Esperion's corporate headquarters are located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.

Position Title: Manager, Aggregate Spend / Transparency
The Aggregate Spend/Transparency Manager assists the Chief Ethics and Compliance Officer in the development, implementation and management of the Company's healthcare compliance program, focusing on the collection, analysis, and reporting of payments, transfers of values, samples, and/or pricing data to various government agencies at the federal, state and local level. The Manager of Aggregate Spend / Transparency must exhibit the highest level of integrity and ethics.

Preferred Location: Remote - US

Essential Duties and Responsibilities*
The Aggregate Spend Manager will be responsible for developing and maintaining systems, processes, and programs to facilitate Esperion's accurate collection, tracking, analysis, and reporting of payments and transfers of value to physicians, allied healthcare professionals, and teaching hospitals to meet the requirements at the federal, state and local level such as reporting to CMS Open Payments. The position will be remote with travel to Ann Arbor, Michigan and to various locations within New Jersey.

Responsibilities include but are not limited to:

  • Implement and oversee a third-party system for aggregate spend tracking and reporting
  • Develop and maintain standard operating procedures, policies and/or work practices related to the collection of data for aggregate spend tracking and reporting purposes
  • Lead the Aggregate Spend cross-functional working group and partner with all functional areas to drive compliance
  • Develop training for employees and third party vendors
  • Develop processes (including automated workflows) to obtain all potentially reportable data from internal systems and those of third party vendors
  • Conduct reviews and assess the integrity of payments and transfers of value data and liaise with relevant departments to obtain information about payments and transfers of value to ensure accuracy
  • Prepare transparency reports required at the federal, state and local levels. Such reports may include payments and transfers of value, samples, and price reporting.
  • Develop a process to facilitate the review and approval by relevant leadership and certifiers to the report.
  • Monitor compliance with Esperion policy related to caps on fees and transfers of value to healthcare professionals and organizations
  • Receive, investigate, remediate, and respond to inquiries from physicians, healthcare professionals and organizations related to disclosures of payments, transfers of value, samples, etc.
  • If necessary, lead the effort to revise and resubmit data
  • Stay abreast of laws and regulations related to transparency at the federal, state, and local level
  • As necessary, ensure audits are conducted periodically of internal and external sources of spend (e.g., conduct an annual audit of the submission to CMS Open Payments for accuracy and completeness)
  • Provide quarterly reports to Esperion's Compliance Committee.
*additional duties and responsibilities not listed here may be required

Qualifications (Education & Experience):

  • Bachelor's degree or higher is a Minimum Qualification
  • 2 to 4 years of pharmaceutical industry experience focused on transparency requirements (federal, state, local) related to payments and transfers of value.
  • Excellent verbal and written communication skills
  • Working knowledge of the compliance issues facing the biopharmaceutical industry, including the various healthcare, anti-corruption and privacy laws and regulations that govern the research, development, manufacturing, sale and marketing of biopharmaceutical products
  • Ability to work in a fast-paced environment and handle multiple, conflicting priorities while managing a substantial workload.
  • Demonstrated ability to think strategically and pay close attention to detail.
  • Strong ability to work collaboratively, build credibility and communicate effectively with individuals and teams at all levels of the organization and to inspire confidence and support for compliance initiatives.
Travel will be less than 10%. Some overnight travel may be required.

Notice to Agency and Search Firm Representatives: Esperion Therapeutics is not accepting unsolicited assistance from agencies and/or search firms for any job posted on this or a referring site. Please, no phone calls or emails. All resumes submitted by an agency and/or search firm to any employee at Esperion via email, the internet, or in any other form and/or method without a valid written agreement in place will be deemed the sole property of Esperion. No fees will be paid in the event that a candidate is hired by Esperion as a result of an unsolicited agency and/or search firm referral.

All qualified applicants are requested to submit a cover letter and CV via email to hr@esperion.com.


 Apply here
Posted 8/2/2019

SENIOR COMPLIANCE COUNSEL, NEUROLOGY AND IMMUNOLOGY - EMD Serono
Location: Rockland, MA

A career with EMD Serono is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

Your role:
Reporting to the SVP of Compliance for North America, the Senior Compliance Counsel will be empowered to lead the efforts to build the compliance program with focus on governance, risk assessment, policies and procedures, training, monitoring, investigations, and management. This counsel will lead compliance for EMD Serono's Neurology and Immunology franchises in the US.

  • Design and implement the compliance program and strategy for EMD Serono Canada ensuring alignment with a US compliance programs.
  • Develop relationships with key stakeholders throughout the company and promote compliance program.
  • Design, develop, and advance compliance training programs and processes that align to the expected organizational standards and ensure compliance awareness is maintained.
  • Act as a channel of communication to receive and direct global and local compliance information appropriately.
  • Identify business strategies and tactics that present compliance risk and provide input into compliance risk assessment and mitigation remediation strategies.
  • Support compliance investigations through collection of information and facilitation of interviews between investigations team and business stakeholders and support implementation of corrective action measures.
  • Identify promotional practice and related risk areas by assessing the execution of existing compliance programs
  • Communicate with Business Partners on field-level activities to keep abreast of emerging issues at the regional level
  • Identify gaps in sales and marketing team training programs through monitoring activities
  • Stay up to date of changes to laws and regulations with healthcare compliance related to promotional activities

Who you are:

  • Juris Doctorate
  • Minimum of 7 years of work experience in a Legal or Compliance function with a multi-national organization with specialization in Pharmaceutical compliance, law and regulations.
  • Senior level collaborator with ability to influence and gain buy in at the leadership level.
  • Established reputation for excellence in traits such as credibility, integrity, confidentiality, and trust.
  • Collaboratively work across department and geographies and encourage teamwork that respects backgrounds and culture diversity.
  • Innovative approach, creative thinker.
  • Embracing new opportunities that will shape the future.
  • Driving innovative changes t-open to new ideas and working in a decisive.
  • Participate in a feedback culture and take responsibility.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Find more information at https://jobs.vibrantm.com.
 Apply here
Posted 7/13/2019

COMPLIANCE COUNSEL, NORTH AMERICA (US AND CAN) - EMD Serono
Location: Rockland, MA

A career with EMD Serono is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

Your role:
Reporting to the SVP of Compliance for North America, the Compliance Counsel, North America will be empowered to lead the efforts to build the compliance program with focus on governance, risk assessment, policies and procedures, training, monitoring, investigations, and management. This counsel will lead compliance for EMD Serono, Canada and support the Chief Compliance Officer in supporting Fertility and Endocrinology for US.

  • Design and implement the compliance program and strategy for EMD Serono Canada ensuring alignment with the US compliance programs.
  • Develop relationships with key stakeholders throughout the company and promote compliance program.
  • Design, develop, and advance compliance training programs and processes that align to the expected organizational standards and ensure compliance awareness is maintained.
  • Act as a channel of communication to receive and direct global and local compliance information appropriately.
  • Identify business strategies and tactics that present compliance risk and provide input into compliance risk assessment and mitigation remediation strategies.
  • Support compliance investigations through collection of information and facilitation of interviews between investigations team and business stakeholders and support implementation of corrective action measures.
  • Identify promotional practice and related risk areas by assessing the execution of existing compliance programs
  • Communicate with Business Partners on field-level activities to keep abreast of emerging issues at the regional level
  • Identify gaps in sales and marketing team training programs through monitoring activities
  • Stay up to date of changes to laws and regulations with healthcare compliance related to promotional activities

Who you are:

  • Juris Doctorate
  • Minimum of 5 years of work experience in a Legal or Compliance function with a multi-national organization with specialization in Pharmaceutical compliance, law and regulations.
  • Senior level collaborator with ability to influence and gain buy in at the leadership level.
  • Established reputation for excellence in traits such as credibility, integrity, confidentiality, and trust.
  • Collaboratively work across department and geographies and encourage teamwork that respects backgrounds and culture diversity.
  • Innovative approach, creative thinker.
  • Embracing new opportunities that will shape the future.
  • Driving innovative changes t-open to new ideas and working in a decisive.
  • Participate in a feedback culture and take responsibility.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Find more information at https://jobs.vibrantm.com.
 Apply here
Posted 7/13/2019

SENIOR COMPLIANCE COUNSEL, ONCOLOGY - EMD Serono
Location: Rockland, MA

A career with EMD Serono is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

Your role:
Reporting to the SVP of Compliance for North America, the Senior Compliance Counsel will be empowered to lead the efforts to build the compliance program with focus on governance, risk assessment, policies and procedures, training, monitoring, investigations, and management. This counsel will lead compliance for EMD Serono's Oncology franchise in the US.

  • Design and implement the compliance program and strategy for EMD Serono Canada ensuring alignment with the US compliance programs.
  • Develop relationships with key stakeholders throughout the company and promote compliance program.
  • Design, develop, and advance compliance training programs and processes that align to the expected organizational standards and ensure compliance awareness is maintained.
  • Act as a channel of communication to receive and direct global and local compliance information appropriately.
  • Identify business strategies and tactics that present compliance risk and provide input into compliance risk assessment and mitigation remediation strategies.
  • Support compliance investigations through collection of information and facilitation of interviews between investigations team and business stakeholders and support implementation of corrective action measures.
  • Identify promotional practice and related risk areas by assessing the execution of existing compliance programs
  • Communicate with Business Partners on field-level activities to keep abreast of emerging issues at the regional level
  • Identify gaps in sales and marketing team training programs through monitoring activities
  • Stay up to date of changes to laws and regulations with healthcare compliance related to promotional activities

Who you are:

  • Juris Doctorate
  • Minimum of 7 years of work experience in a Legal or Compliance function with a multi-national organization with specialization in Pharmaceutical compliance, law and regulations.
  • Senior level collaborator with ability to influence and gain buy in at the leadership level.
  • Established reputation for excellence in traits such as credibility, integrity, confidentiality, and trust.
  • Collaboratively work across department and geographies and encourage teamwork that respects backgrounds and culture diversity.
  • Innovative approach, creative thinker.
  • Embracing new opportunities that will shape the future.
  • Driving innovative changes t-open to new ideas and working in a decisive.
  • Participate in a feedback culture and take responsibility.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Find more information at https://jobs.vibrantm.com.
 Apply here
Posted 7/13/2019

COMPLIANCE LEAD, BUSINESS INTEGRITY AND ETHICS --- OR --- LEAD, ETHICS & COMPLIANCE AUDITING AND MONITORING - EMD Serono
Location: Rockland, MA

Your role:
The Integrity and Ethics Operations Lead is responsible for executing against the EMD Serono Compliance Department's annual Monitoring & Auditing (M&A) strategic plan. The lead will conduct monitoring activities and audits of various company records, manage the development and implementation of remediation & mitigation processes, assist with investigations related to findings and allegations of non-compliance with Company policy, prepare regular reports and presentations in a form that is consistent with internal and external reporting requirements.

  • Monitor field Commercial, Medical Affairs and Managed Markets transactions, activities, and processes and perform transactional monitoring to assess compliance with Company policies and procedures.
  • Manage and prioritize multiple complex projects; collaborating with multi-functional subject matter experts and stakeholders, as required.
  • Prepare and provide reports, presentations, materials, guidelines, and documents for employees, senior management.
  • Develop and demonstrate knowledge and competency to serve as a compliance and ethics subject matter expert.
  • Support the Chief Compliance Officer and other leaders in Compliance with E&C Monitoring & Auditing in facilitating and raising awareness of the Ethics & Compliance program while fostering accountability for compliance throughout the organization.
  • Maintain understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical compliance and proposes updates to ethics & compliance program, as appropriate.
  • Identify, analyze, and mitigate potential business and ethics risks to the organization.
  • Support the development and manage the implementation of a robust ethics and compliance monitoring and auditing plan.
  • Develop and maintain knowledge and understanding of EMD Serono's disease states and products and industry regulations and guidelines - laws and regulations regarding pharmaceutical advertising and promotion, Federal Anti-Kickback Statute, False Claims Act, as well as EMD Serono policies and procedures, and government reporting requirements as needed.
  • Develop and manage protocols, guidelines and associated internal communication and documentation related to E&C testing and monitoring.
  • Develop and manage the remediation and mitigation process on for the M&A team
  • Review records and systems relating to interactions with healthcare professionals and institutions, conduct field monitoring visits and monitor various company-sponsored activities to ensure adherence with relevant laws, regulations, industry codes, and company policies.
  • Support E&C audits for North America with the potential to gain exposure to global activities in support of annual auditing plan and/or ad hoc audits as requested.
  • Review and follow-up on suspected areas of non-compliance and collaborate with EMD Serono Ethics & Compliance teams as needed.
  • Prepare reports and presentations summarizing monitoring and auditing findings and remediation for management and external government agencies as requested.

Who you are:

  • Extensive working knowledge of US and international fraud and abuse laws and regulations - such as the False Claims Act, the Anti-Kickback Statute, the Foreign Corrupt Practices Act, and the UK Bribery Act - and should have experience working with or for biotechnology/pharmaceutical companies on these issues.
  • Ability to work collaboratively and strategically with colleagues in legal and the business to drive a culture of ethics and integrity across the global organization.
  • Bachelor's degree from an accredited institution required
  • A minimum of 5 years combined pharmaceutical, legal, regulatory, and compliance experience required.
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, Food & Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements, PhRMA code, and other relevant reporting requirements.
  • Compliance monitoring and auditing experience in the Pharmaceutical or life sciences industry is strongly preferred.
  • Experience working under a government agreement (e.g. Corporate Integrity Agreement, Consent Decree, etc.) is required
  • Demonstrates strong interpersonal skills and ability to influence at all levels of the organization.
  • Ability to manage multiple projects concurrently and collaborate across several functional areas, meeting internal and external deliverables with high degree of accuracy.
  • Highest level of ethics and personal integrity

Curious? Find more information at https://jobs.vibrantm.com.
 Apply here
Posted 7/13/2019