- Responsible for establishment and leadership of an effective global healthcare compliance program
- Strategic compliance advisor to the Board of Directors and the management team
- Healthcare law and data privacy legal advisor to the entire company
- Responsible for the compliance program with respect to data privacy/protection, anti-bribery, and corporate compliance.
- Senior member of the Legal & Compliance team, a highly visible representative for the team
- Design, implement and maintain an effective global healthcare compliance program encompassing compliance with healthcare laws and ethical codes
- Engage employees, management and Board with the compliance agenda, its strategic importance to the business and its relationship to our values and goals;
- Design, implement, administer, and continuously improve an effective global healthcare compliance program, including policies and procedures, compliance committees, training, communication, monitor and auditing, enforcement, and investigations
- Design, implement, and maintain system to check for excluded individuals/entities;
- Review and advise on publications, promotional / pre-promotional materials, presentations, and agreements concerning dealings with Healthcare Professionals (HCPs), patients, patient advocacy groups, payors, and reporting.
- Responsible for the compliance program with respect to data privacy/protection, anti-bribery, and corporate compliance in partnership with other subject matter experts and functional leads
- Responsible for implementing and conducting price and transparency reporting
- Responsible for providing legal advice to the organization on pre-commercial and commercial healthcare law issues as well as data privacy issues
- Responsible for managing any external resources that may be required, ensuring company receives high-quality advice on time and on budget
- Stay connected across the business in a monitoring role to identify and proactively address compliance issues
- Support the Head of Legal in compliance and healthcare law matters as well as administrative matters
- Grow and mature the Compliance function and the Healthcare legal function
- JD from accredited law school and license to practice in at least one US jurisdiction; compliance certification preferred
- Minimum of 15 years of experience in healthcare compliance and healthcare law, preferably with experience in a clinical-stage biotechnology company and a top-tier law firm
- Comprehensive knowledge of and experience in all US compliance topics
- Experience with compliance regimes outside of the US in major ex-US markets
- Experience with data privacy (g., GDPR, state privacy laws)
- Experience in an in-house role
- Experience interacting with a management team and/or a Board of Directors
- Experience in the design and implementation of a healthcare compliance program for a growing biotechnology company
- Proven self-starter and multi-tasker in a fast-paced environment
- Excellent communication, writing and computer skills
- Ability to collaborate well with internal and external stakeholders
- Excellent analytical, organizational and information-seeking skills; detail oriented
- Exceptional business judgment, with the ability to think strategically and give practical advice while balancing business needs with legal risks
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VP, Head of Compliance - Waltham, United States - Dyne Therapeutics Inc
Description
Company Overview:
Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).
Role Summary:
In this role, the Head of Compliance will design, implement, and administer a comprehensive compliance program appropriate to the size and stage of Dyne that is scalable as Dyne transitions to a commercial stage company. The Head of Compliance also will act as the primary resource for healthcare law legal counseling across the entire organization. The person in this role will work with our CEO and Board of Directors
This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.
Primary Responsibilities Include:
Education and Skills Requirements:
#LI-Onsite
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
