Location: Metro Washington DC area
Contact: Jackie Bandish, firstname.lastname@example.org
Senior/Associate Director Strategic Scientific Writer | Leading Global Biopharmaceutical Company
This Senior Strategic Scientific Writer search is being conducted on behalf of our global biopharmaceutical client. Our client seeks an individual who wants to take their medical writing career to the next level. In this role one will focus on the high-level submission documents that summarize and interpret the clinical data for a new drug.
This is an opportunity to be a part of an elite group of 28 global medical writers that focus on submission authoring and big summary documents. The level is dependent on the skills set you bring to the organization. This is a great opportunity for the writer who wants to go beyond individual study-level documents and lead the development of whole submissions. There is also leadership opportunity.
There are three elements that make this a diverse and exciting job. First, one will develop communication strategies and plans, understanding the science behind a new drug, and using that understanding to lead high-level teams in developing a communication strategy that drives regulatory submissions. Second, one will author the most complex and interesting documents, like Clinical Overviews. Third, one will lead a team to author and deliver all the other clinical documents for the submission.
ADDITIONAL INFORMATION ABOUT THIS COMPANY AND ROLE:
Large Global Biotechnology Company with over 2,200 employees.
This job offers autonomy, the opportunity for career development to move across all therapy areas, a supportive manager who coaches and supports and high- profile status interacting with physicians and statisticians as equal partners.
Wonderful opportunity for an individual who wants to move their medical writing career up a level.
This is not a remote role. Our client offers a relocation package.
HIGHLIGHTS OF RESPONSIBILITIES:
Lead development of the clinical submission communication strategy for a new product, liaising with senior project staff.
Prospectively develop a storyboard for the submission and identify how the proposed prescribing information will be supported.
Lead the authoring of clinical documents for the NDA and MAA.
Ensure alignment of clinical submission documents with the proposed prescribing information.
Represent medical writing on the high-level, cross-functional submission team.
DESIRED SKILLS AND QUALIFICATIONS:
Bachelor's degree in the life sciences preferably with an MS or PhD.
Minimum of two years' experience within the pharmaceutical/medical industry/CRO.
Jackie Bandish, Head of Life Sciences Recruiting and Operations
Phone: 267-483-5233 x 104
The Bandish Group, LLC
Life Sciences Executive Search
1432 Easton Road, Suite 2B
Warrington, PA 18976