Head of Medical Writing

Job Description

About This Role

The Head of Medical Writing (MW) will be accountable for overseeing the development of high-quality regulatory documents that comply with global regulatory requirements for all Biogen products from FIH through marketed. He/She will oversee a team of medical writers and external resources that will be accountable for collaborating with cross-functional teams to drive strategic document writing and improve overall study efficiency. This role will have visibility and influence to the most senior levels of the organization, partnering to drive overall clinical development success. The Head of MW will report to the SVP, Head of Safety & Regulatory Operations, Medical Writing and Benefit Risk Management.

What You’ll Do

• Oversee development and writing of a wide range of regulatory documents across all Biogen therapeutic areas, including but not limited to protocols, clinical study reports and filing documents
• Collaborate with leaders of cross-functional teams to drive strategic messaging in development of regulatory documents
• Identify and drive implementation of process improvements and innovation to drive implementation of best practices in medical writing
• Effectively resource the function with the appropriate balance of internal staff and full-service providers, updating as needed to accommodate business priorities
• Keep up to date with changes in regulatory guidelines to ensure documents are fit for purpose and team is trained on evolving regulations

Who You Are

You have a strategic mindset and a willingness to drive innovation. You have a strong scientific background and a deep knowledge of drug development. You are motivated to improve efficiency and effectiveness while maintaining quality, and to utilize the medical writing function as a driver for Biogen’s success.

Qualifications

Required Skills

• Education with degree in life or health science discipline, advanced degree preferred
• 15 years experience in Life Science Industry with experience in Medical Writing, Regulatory or Safety
• Significant people manager experience
• Ability to navigate a global and matrixed organization
• Strong written and verbal communication skills

Additional Information

The base compensation range for this role is $214,000 - $357,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.