Director, Medical Writing

🔥 17 hours ago

🇺🇸 United States – Remote

💵 $191k - $263k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• Prepare and/or manage complex marketed and development programs at the portfolio level • Directly supervise Medical Writing program leads and respond to Medical Writing issues with internal cross-functional teams and external development partners • Contribute to the department’s long-term growth strategy • Ensure standard procedures are followed across and within projects • Synchronize project prioritization • Represent Medical Writing in meetings with governance committees, regulatory agencies, and external development partners • Maintain knowledge of evolving/emerging industry standards and establish medical writing best practices • Prepare clinical and regulatory documents and packages, including protocols and amendments, CSRs, IBs, INDs/CTAs, and submissions • Lead planning, development, and delivery of documents according to ICH guidelines, company SOPs, templates, and regulatory requirements • Support development and maintenance of SOPs and templates • Analyze and synthesize complex scientific information and ensure document scientific accuracy and consistency • Develop and integrate messaging and medical writing strategy across therapeutic areas and/or disease states • Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Clinical Operations SMEs • Participate in regulatory submission planning, timelines, and document development • Manage and/or oversee in-house and contractor/vendor medical writers • Mentor junior writers and provide professional development guidance • Serve as Medical Writing liaison for one or more Functional Service Providers when needed • Provide mentoring and career development to direct reports • Review statistical analysis plans and clinical data reports incorporated into CSRs, IBs, and other data-related documents • Provide strategic input to TFL outputs to streamline TFL production • Lead departmental initiatives as necessary

🎯 Requirements

• 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 • Proficiency in document management systems (Veeva, SharePoint) • Experience in managing and/or mentoring other medical writers or external vendors preferred • Exceptional written and communication skills • Experience working in a matrix environment and collaborating with clinical teams • Strong regulatory writing experience • Expert knowledge of global requirements related to clinical regulatory documentation supporting Phase 1-4 clinical development • Demonstrated management, scientific, and customer-focused leadership skills

🏖️ Benefits

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