Associate Director, Medical Writing
About the role
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. The company develops innovative products that help treat neurological and psychiatric conditions and currently has 8 products on the market impacting patient outcomes.
The Associate Director of Medical Writing will provide leadership and functional oversight for multiple programs reporting to the Head of Medical Writing. This role will independently plan, lead, provide guidance to matrixed stakeholder teams, and develop content for clinical and regulatory documents in accordance with company guidelines to support regulatory filings.
Responsibilities
- Provide strategic input into program-level plans for document development and authoring, and deliverable-level timelines to meet program goals.
- Provide leadership and guidance at the team level as a subject‑matter expert for document scope and content.
- Contribute strategically and scientifically at the study team level with recommendations for data reviews, collection of specific data, data outputs, and document content.
- Proactively advise study and submission teams regarding regulatory requirements and ICH guidance for clinical documents.
- Align, coordinate, and build consistent information and messages across clinical program(s) for deliverables.
- Independently plan, manage, and author routine and complex documents supporting clinical development and submissions, including clinical synopses and protocols, clinical study reports, investigator brochures, annual safety reports, abstracts and manuscripts, and documents for NDA, BLA, IND, CTA, SOPs, etc.
- Review and provide oversight of documents prepared by outside contractors for content, clarity, accuracy, consistency, and alignment with company position.
- Proactively anticipate risks, provide solutions, and take necessary actions to mitigate risks, managing stakeholder expectations.
- Participate in developing and implementing goals and initiatives for the Medical Writing department.
- Facilitate implementation of new technologies and initiatives at the enterprise level related to preparation of clinical regulatory documents.
- Provide leadership and management consistent with Company Values toward defined Corporate Objectives; understand Company policy and procedure to guide direct reports appropriately.
- Perform other responsibilities and projects as assigned.
Requirements
- Bachelor’s degree in a physical or life science required with a minimum of 8+ years of experience, or a Master’s degree with a minimum of 6+ years of relevant medical writing and project management experience.
- PhD degree is highly desirable with a minimum of 5+ years relevant work experience in pharmaceutical companies or CROs.
- Experience in clinical research or medical/clinical writing in a pharmaceutical or CRO setting is preferred.
- Demonstrated direct clinical regulatory writing experience in a pharmaceutical, biotech, or CRO environment.
- Demonstrated ability to lead, collaborate, and manage people.
- Authorized to legally work in the United States without visa sponsorship.
Skills
- Strong understanding of Microsoft Office.
- Experience with Veeva Vault document management.
- Working knowledge of medical terminology.
- Familiarity with relevant regulatory guidance, especially ICH E6 and E3.
Benefits
- Competitive benefits package including health, dental, vision, paid time off, 401(k) company match, company‑paid life insurance, and health and wellness benefits.
- Stock equity awards, employee stock purchase programs, and participation in the company’s discretionary annual bonus program.
Pay
The expected salary range for fully qualified candidates is $166,000 to $193,000. Salary within the range is based on factors such as education, relevant experience, knowledge, length of industry experience, and organizational needs.