Director, Medical Writing

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

📋 Description

• Prepare and/or oversee intricate marketed and development programs at the portfolio level.

• Directly manage Medical Writing program leads and address Medical Writing concerns with internal cross-functional teams and external development partners.

• Contribute to the long-term growth strategy of the department.

• Ensure adherence to standard procedures across various projects.

• Coordinate project prioritization effectively.

• Represent Medical Writing in meetings with governance committees, regulatory agencies, and external development partners.

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

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

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

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

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

• Develop and integrate messaging and medical writing strategies across therapeutic areas and/or disease states.

• Collaborate with subject matter experts from Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Clinical Operations.

• Engage in regulatory submission planning, timelines, and the development of documents.

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

• Mentor junior writers and provide guidance for professional development.

• Serve as the Medical Writing liaison for one or more Functional Service Providers as needed.

• Provide mentoring and career development opportunities to direct reports.

• Review statistical analysis plans and clinical data reports included in CSRs, IBs, and other data-related documents.

• Offer strategic insights on TFL outputs to enhance TFL production.

• 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 (in a pharmaceutical, biotechnology, or CRO setting).

• Experience with global regulatory submissions (e.g., BLA/NDA, MAA).

• Knowledge of eCTD format and the relationships between documents.

• Familiarity with ICH, FDA, and EMA guidelines and regulations, along with public disclosure requirements for documents.

• Proven experience in authoring documents and leading teams throughout the authoring process.

• Strong project management abilities, capable of prioritizing and managing multiple projects in a high-paced environment.

• Subject Matter Expert in MS Word.

• Proficient in document management systems (Veeva, SharePoint).

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

• Outstanding written and communication skills.

• Experience in a matrix environment and collaboration with clinical teams.

• Strong regulatory writing expertise.

• Extensive knowledge of global requirements concerning clinical regulatory documentation for Phase 1-4 clinical development.

• Demonstrated leadership skills focused on management, scientific excellence, and customer orientation.

🏝️ Benefits

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

• Comprehensive Medical, Dental, Vision, & Life insurances.

• Fitness & Wellness programs, including reimbursement for fitness expenses.

• Short- and Long-Term Disability insurance.

• A minimum of 15 days of paid vacation, plus additional time off for an end-of-year shutdown (Dec 26-Dec 31).

• Up to 12 company-paid holidays, along with 3 paid days off for Personal Significance.

• 80 hours of sick leave available each calendar year.

• Paid Maternity and Parental Leave benefits.

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

• Employee stock purchase plan.

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

• Opportunity to participate in Employee Resource Groups.