Director, Medical Writing

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $191k - $263k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 medical writing programs at the portfolio level • 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 and ensure standard procedures are followed • Synchronize project prioritization and represent Medical Writing in governance committee, regulatory agency, and external partner meetings • Maintain awareness of evolving industry standards and establish medical writing best practices • Prepare clinical and regulatory documents and packages, including protocols, 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 while ensuring document accuracy and consistency • Develop and integrate messaging and medical writing strategy across therapeutic areas and disease states • Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Clinical Operations SMEs • Participate in regulatory submission planning, timelines, and document development • Manage or oversee in-house and contractor/vendor medical writers • Mentor junior writers and provide professional development guidance • Serve as Medical Writing liaison for Functional Service Providers when applicable • Provide mentoring and career development to direct reports • Review statistical analysis plans and clinical data reports incorporated into data-related documents • Provide strategic input to TFL outputs • Lead departmental initiatives as necessary

🎯 Requirements

• Minimum of BSc plus 12 years’ experience in Medical Writing, or advanced degree plus 7 years’ experience in Medical Writing • Experience in a pharmaceutical, biotechnology, or CRO setting • Experience with global regulatory submissions, such as BLA/NDA and MAA • Familiarity with eCTD format and document relationships • Familiarity with ICH, FDA, and EMA guidelines and regulations • Familiarity with public disclosure requirements for documents • Proven experience authoring documents and leading teams through the authoring process • Strong project management skills and ability to prioritize and manage multiple projects in a fast-paced environment • SME-level knowledge of MS Word • Proficiency in document management systems, including Veeva and SharePoint • Exceptional written and communication skills • Experience working in a matrix environment with clinical teams • Strong regulatory writing experience • Expert knowledge of global clinical regulatory documentation requirements across Phase 1–4 • Demonstrated management, scientific, and customer-focused leadership skills • People management experience preferred, but not required • Experience managing and/or mentoring medical writers or external vendors preferred

🏖️ 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 • 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 • Learning, growth, and expanding skills opportunities