Director, Medical Writing - WCH

Biogen

1d • $191,000 - $263,000

About The Position

As the Director of Medical Writing for the West Coast Hub (WCH), you are responsible for writing and/or managing complex marketed and development programs at the portfolio level based on Therapeutic Area, disease state, and/or phase of development. You are also responsible for providing direct supervision for the Medical Writing program leads, including response to potential Medical Writing issues with internal cross-functional teams and external development partners. You will contribute to the long-term growth strategy of the department and ensure that standard procedures are followed across and within projects. You will synchronize prioritization of projects and in some cases, he/she represents Medical Writing in meetings with governance committees, regulatory agencies, and external development partners. Performs outreach within pharmaceutical/biotech industry to maintain knowledge of evolving/emerging industry standards and to establish medical writing best practices within company.

Requirements

• Exceptional written and communication skills.
• Successfully worked in a matrix environment where you collaborated with other clinical teams.
• Strong regulatory writing experience.
• Strong teamwork capabilities.
• Expert knowledge of global requirements related to all aspects of clinical regulatory documentation to support all phases of clinical development (Phase 1-4).
• Acts as a medical writing subject matter expert to other departments.
• Demonstrated management, scientific, and customer-focused leadership skills.
• Minimum of BSc + 12 years’ experience in Medical Writing, or Advanced degree + 7 years’ experience in Medical Writing (pharmaceutical, biotechnology, or CRO setting).
• Experience with global regulatory submissions (e.g. BLA/NDA, MAA).
• Familiarity with eCTD format and relationships between documents.
• Familiarity with ICH, FDA, and EMA guidelines and regulations, as well as public disclosure requirements for documents.
• Proven experience authoring documents and leading teams through the authoring process.
• Strong project management skills with the ability to prioritize and manage multiple projects in a fast-paced environment.
• SME in MS Word, and proficiency in document management systems (Veeva, SharePoint).

Nice To Haves

• People management skill is nice to have but not must have.
• Experience in managing and/or mentoring other medical writers or external vendors preferred.

Responsibilities

• Prepare clinical and regulatory documents and packages: protocols and amendments, CSRs, IBs, INDs/CTAs, submissions.
• Lead the planning, development, and delivery of documents according to ICH guidelines, company SOPs, templates, and regulatory requirements.
• Support the development and maintenance of SOPs and templates for document development.
• Critically analyze and synthesize complex scientific information, and ensure scientific accuracy and consistency of documents.
• Develop and integrate messaging and medical writing strategy and ensure consistency through documents in a therapeutic area and/or disease state.
• Collaborate with cross-functional SMEs including (but not limited to), Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, Clinical Operations.
• Participate in regulatory submission planning, timelines, and document development.
• Manage and/or provide oversight of in-house and/or contractor/vendor medical writers, ensuring high-quality deliverables.
• Mentor and provide professional development guidance to junior writers.
• Serve as the MW liaison for one or more Functional Service Providers (FSP).
• Provide mentoring and career development to direct reports to create a high-quality and productive group.
• Review statistical analysis plans and clinical data reports that are incorporated in data-related documents (CSRs, IBs, etc).
• Provide strategic input to TFL outputs to streamline TFL production.
• Lead departmental initiatives as necessary.

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an 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 time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

What This Job Offers

• Job Type: Full-time
• Career Level: Manager