Director, Medical Writing

This is a fully remote position, open to applicants in United States.

📋 Description

• Prepare and/or oversee intricate marketed and developmental medical writing initiatives at the portfolio level.

• Supervise Medical Writing program leads and address Medical Writing challenges alongside internal cross-functional teams and external development partners.

• Contribute to the long-term growth strategy of the department while ensuring adherence to standard procedures.

• Coordinate project prioritization and represent Medical Writing in governance committee, regulatory agency, and external partner meetings.

• Stay informed about changing industry standards and establish best practices in medical writing.

• Create clinical and regulatory documents and packages, including protocols, amendments, CSRs, IBs, INDs/CTAs, and submissions.

• Lead the planning, creation, and delivery of documents in accordance with ICH guidelines, company SOPs, templates, and regulatory requirements.

• Assist in the development and maintenance of SOPs and templates.

• Analyze and synthesize complex scientific information, ensuring document accuracy and consistency.

• Develop and implement messaging and medical writing strategies across various therapeutic areas and disease states.

• Collaborate with SMEs from Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Clinical Operations.

• Engage in planning for regulatory submissions, timelines, and document development.

• Manage or oversee both in-house and contractor/vendor medical writers.

• Mentor junior writers and provide guidance for professional development.

• Act as the Medical Writing liaison for Functional Service Providers when applicable.

• Offer mentoring and career development for direct reports.

• Review statistical analysis plans and clinical data reports included in data-related documents.

• Provide strategic input for TFL outputs.

• Lead departmental initiatives as required.

⛳️ Requirements

• A minimum of a BSc with 12 years of experience in Medical Writing, or an advanced degree with 7 years of experience in Medical Writing.

• Experience in a pharmaceutical, biotechnology, or CRO environment.

• Familiarity with global regulatory submissions, including BLA/NDA and MAA.

• Knowledge of eCTD format and document relationships.

• Understanding of ICH, FDA, and EMA guidelines and regulations.

• Awareness of public disclosure requirements for documents.

• Demonstrated experience in authoring documents and leading teams through the authoring process.

• Strong project management capabilities, with an ability to prioritize and manage multiple projects in a dynamic environment.

• SME-level expertise in MS Word.

• Proficient in document management systems, such as Veeva and SharePoint.

• Exceptional written and verbal communication skills.

• Experience collaborating in a matrix environment with clinical teams.

• Extensive background in regulatory writing.

• Expert knowledge of global clinical regulatory documentation requirements spanning Phases 1–4.

• Proven management, scientific, and customer-focused leadership abilities.

• People management experience is preferred but not mandatory.

• Experience in managing and/or mentoring medical writers or external vendors is preferred.

🏝️ Benefits

• Short-term and long-term incentives, including cash bonuses and equity incentive opportunities.

• Medical, Dental, Vision, & Life insurance options.

• Fitness & Wellness programs, including a fitness reimbursement.

• Short- and Long-Term Disability insurance coverage.

• A minimum of 15 days of paid vacation annually.

• Additional end-of-year shutdown time off (Dec 26-Dec 31).

• Up to 12 company-paid holidays.

• 3 paid days off for Personal Significance.

• 80 hours of sick leave per calendar year.

• Paid Maternity and Parental Leave benefits.

• Participation in a 401(k) program with company-matched contributions.

• Employee stock purchase plan available.

• Tuition reimbursement of up to $10,000 per calendar year.

• Opportunities for participation in Employee Resource Groups.

• Access to learning, growth, and skill expansion opportunities.