About This Role:

As the Associate Director, Medical Writing you provide leadership and functional oversight for one or more clinical program. You function as a strong project manager and technical leader, with demonstrated scientific and customer-focused leadership skills. You will 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). Will also partner with R&D departments to ensure timely completion of high-quality clinical regulatory documents. The AD, Medical Writing is required to 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.

What You’ll Do:

You will provide leadership in the development of Global Medical Writing processes and standards, perform outreach within the pharmaceutical/biotech industry to maintain knowledge of evolving/emerging industry standards and to establish medical writing best practices within company. You will provide mentoring and career development to junior medical writers and as applicable to direct reports.

·       Provide Medical Writing leadership for a clinical program or programs. Acts as a medical writing subject matter expert and works with clinical development team to deliver on medical writing program goals.

·       Responsible for managing medical writing deliverables for clinical programs within their responsibility. Provides guidance to internal and external writers on prioritization, content and timeline development, and process management.

·       Provides leadership and contributes to overall department strategies and initiatives. Plans and allocates resources as appropriate and ensures resource alignment with program needs.

·       Maintains cutting edge knowledge base of current developments in field and related technologies. Incorporates process improvements and changes that align with R&D needs. Develops training programs and processes that ensure medical writing staff learn and develop program-specific knowledge.

·       Contributes to a culture of customer focus and continual process improvement. Manages process re-design(s) that ensure fast-paced program milestones are met and high-quality clinical regulatory documentation is produced. 

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.  Experience in resource planning/allocation and project management experience.

#LTD-1

Required Skills

10 years of experience in the biopharmaceutical industry with 7 years of direct medical writing experience (advanced degree/academic research may be considered in lieu of industry experience).

·       Expert knowledge of standard clinical regulatory document types.

·       Experience working in relevant therapeutic areas.

·       Experienced in resource planning and management experience with virtual teams, employees based in field locations, and functional service providers.

·       Bachelor’s Degree or equivalent (ex. BS, BA); advanced degree in life or health science discipline preferred

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.