Associate Director, Medical Review - PPD

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 9 products in the market that are making a real impact on patient outcomes.

Job Summary:

This position will work closely with the Medical Director, Postpartum Depression and will have primary responsibility for medical review in both promotional and medical review committees. This role will perform scientific, technical, and quality checks of materials for scientific accuracy, substantiation, quality, and relevant pharmaceutical regulations and codes, and serve a consultive role with cross functional teams in the appropriate development of materials subject to PRC and MRC review. In addition, the Associate Director will have additional responsibilities supporting Medical Affairs strategies and activities related to alliance partnerships.

Essential Duties & Responsibilities:

• Serve as the lead Medical Reviewer for the Promotional Review Committee (PRC) and Medical Review Committee (MRC).
• Provides medical and scientific input on all promotional, medical, and regulatory materials.
• Review and approve promotional and medical content for accuracy and compliance with FDA regulatory standards. Partners functionally with Commercial, Regulatory, Legal, and business partners to provide strategic input and drive alignment as required.
• Advise on content development and messaging to align with company strategy and therapeutic areas.
• Maintain up-to-date knowledge of advertising regulations from FDA/PhRMA, healthcare landscape, including attending relevant training, and sharing relevant outputs.
• Works with Compliance Teams on audits.
• Provide 'second opinions' where appropriate.
• Escalates issues to medical director where appropriate.
• Manages projects assigned by Medical Affairs, Director/Senior Director.
• Other duties as assigned.

Supervisory Responsibilities:

• Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives.
• Understands Company Policy and procedure to be able to guide direct reports appropriately.

Knowledge & Other Qualifications:

• An advanced science or medical degree (PharmD, PhD, MD, PA, NP, RN) and a minimum of five years of relevant experience is required.
• Previous experience in US promotional/medical review is preferred and be comfortable working independently with minimal oversight.
• Demonstrated ability to critically analyze research design, methods, and outcome measures.
• Pharmacoeconomics experience: a focus on quality patient care and patient-oriented outcomes research.
• Commercial/market experience with product launch, clinical development, and Pharmacoeconomics.
• Advanced knowledge of pharmaceutical and medical device guidelines and regulations.
• Experience with an approval system like Veeva PromoMats.

Other Characteristics:

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability of having an innovative and dynamic approach to work.
• A self-starter, able to work independently, but comfortable working in a team environment.
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers, and others.
• Capable of performing other duties as assigned by Management.
• Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements:

• Sedentary work. Exerting up to 20 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
• The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
• The worker is not substantially exposed to adverse environmental conditions.

Compensation:

At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $160,000 to $190,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience, and organizational needs.

Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs.

Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.