Principal Medical Writer

Job Description

About This Role:

The Principal Medical Writer functions as a technical leader with good project management skills and customer-focused leadership and provided functional oversight for a smaller less complex program or programs.  You will prepare clinical regulatory documents, including clinical summaries and clinical trial applications (INDs/CTAs) working in close collaboration with clinical teams to ensure timely completion of high-quality documents.  Through analysis of clinical data, you will independently prepares strategic program level documents such as clinical overviews, briefing packages and responses for regulatory agencies.  You may also provide direction to junior medical writers on submission teams. You will work in collaboration with the TA Lead to appropriately adapt TA area messaging and strategy for a program and are responsible for ensuring consistency of strategy and messaging through all documents for a program.  You are someone who possesses proficient knowledge of global requirements related to all aspects of clinical regulatory documentation to support their program(s) and acts as a medical writing subject matter expert to other departments. 

What You’ll Do:

• Provide Medical Writing leadership and authoring expertise for a smaller less complex program(s).
• Acts as a medical writing subject matter expert and works with the clinical team to deliver on medical writing program goals and document needs within the program.
• Manage medical writing deliverables for program(s) within their responsibility. 
• Provide guidance to and oversight of internal and external writers on prioritization, content and timeline development, and process management.
• Contributes to overall department strategies and initiatives. 
• Incorporates process improvements and changes that align with Department needs. 
• Support the development of training programs and processes to help medical writing staff learn and develop program-specific knowledge.
• Contributes to a culture of customer focus and continual process improvement. 

Who You Are:

In addition to having excellent written and communication skills, you successfully worked in a matrix environment where you collaborated with other clinical teams. You have excellent organizational abilities and function well on cross-functional teams.  You are highly proficient and experienced with most clinical document types.  You have a strong understanding of internal and external guidelines and regulations related to document preparation and program support.

Qualifications

Required Skills

• A Bachelor’s Degree in Life Sciences or health discipline required; Advanced degree preferred.
• 7 years’ experience in the biopharmaceutical industry; advanced degree/academic research or other transferrable skills may be considered in lieu of industry experience
• 5 years of medical writing experience.
• Therapeutic area knowledge and expertise on requirements for clinical / regulatory documents.

#LTD-1

Additional Information

The base compensation range for this role is $121,000 to $194,000. 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.