About This Role:

As the Director of Medical Writing, you are responsible for the functional oversight for complex marketed and development programs at the portfolio level based on Therapeutic Area, disease state, and/or phase of development. You are also responsible for providing direct supervision for the Medical Writing program leads, including response to potential Medical Writing issues 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. Works with the head of Medical Writing and Labeling, to synchronize prioritization of projects and in some cases, he/she represents Medical Writing in meetings with governance committees, regulatory agencies, and external development partners. Performs outreach within pharmaceutical/biotech industry to maintain knowledge of evolving/emerging industry standards and to establish medical writing best practices within company. May need to provide direct medical writing document development support to a program(s) as needs arise.

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.

·       Direct medical writers and MW program leads 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. 

·       Partners 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 acts 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.

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.

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Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.