Job Description
Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.
About This Role:
As the Head of Medical Writing (MW) - Nephrology, you are responsible for the functional oversight of complex development programs under Biogen's emerging nephrology / rare autoimmune disease portfolio. You are also responsible for providing direct supervision for the West Coast Hub Medical Writing team, including response to potential Medical Writing requests 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.
What You'll Do:
- Lead strategy-related discussions related to document development
- Develop and integrate messaging and medical writing strategy and ensure consistency through documents in a therapeutic area and/or disease state.
- Further develop the medical writing function for the nephrology business unit, including adherence with standardized policies, procedures, work instructions, timelines, document tools and templates, and best practices
- Direct medical writers in the preparation of clinical regulatory documents, including clinical summaries/overviews for marketing applications (including global markets and emerging markets) and clinical trial applications (INDs/CTAs) as well as documents to support clinical trials.
- Provide vendor oversight and functional leadership for MW deliverables within the portfolio.
- May 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.
- Partner within R&D to ensure timely completion of high-quality clinical regulatory documents.
- Identify area of process improvement within and outside the department and lead the discussions to implement change
- Represent the department on R&D and other process improvement related initiatives
- Review statistical analysis plans and clinical data reports as needed
- Mentor junior writers on departmental processes related to document preparation (e.g., planning document-related meetings, developing document timelines); reviews documents written by junior writers for content and format
- Lead departmental initiatives
Who You Are:
In addition to having exceptional written and communication skills, you successfully worked in a matrix environment where you collaborated with other clinical teams. You have strong regulatory writing experience and strong teamwork capabilities. You have expert knowledge of global requirements related to all aspects of clinical regulatory documentation to support all phases of clinical development (Phase 1-4), and act as a medical writing subject matter expert to other departments. You are a strong people manager and technical leader, with demonstrated management, scientific, and customer-focused leadership skills.
Qualifications
Required Skills
- A Bachelor's Degree in Life Sciences or health discipline required; Advanced degree preferred
- 12+ years' experience in the biopharmaceutical industry; advanced degree/academic research or other transferrable skills may be considered in lieu of industry experience
- 8+ years of direct medical writing experience
- Therapeutic area knowledge and expertise on requirements for clinical / regulatory documents
- Experience with managing a team of writers to produce high quality deliverables
- 3+ years of people management experience, preferred
#LTD-1
Additional Information
The base compensation range for this role is $178,000.00 to $297,000.00. 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.
