Associate Principal Medical Communications Scientist
Washington, DC 20001
Location: Greater Washington, DC 20001
Company: Top BioPharma
Compensation: $140K Base + Bonus + LTI + Amazing Benefits
Contact: Ken Kupersmith- [email protected]
**** Must Have At Least 2 Years of Authoring Module 2.5 - 2.7 of the CTD for Clinical Study Reports ****
* Role may not be worked remotely, must reside in the Washington, DC area
As an Associate Principal Medical Communications Scientist (Strategic Regulatory Writer), youll play a pivotal role in channeling our scientific capabilities within GMD (Global Medicines Development) driving late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
This role must provide expert communications leadership to late stage drug projects and drive strategic medical writing, advocating communications excellence in your team. He/She ensures that NDA/BLA/MAA/JNDA/CN/ROW clinical documents align with project strategies, meet regulatory requirements and adopt best communications practices.
To be a Strategic Regulatory Writer, you should want to move on from writing study-level documents to authoring more complex documents and submissions, taking on more strategic responsibilities and leading global authoring teams.
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
Author the most complex and important documents (eg, Clinical Overviews, Briefing documents for regulatory authorities and Advisory Committees)
Lead a team of medical writers (internal and external) to deliver
Ensure alignment of clinical submission documents with the proposed prescribing information
Represent medical writing on the high-level, cross-functional submission team
Bachelor's degree in the life sciences preferably with an MS or PhD.
Minimum of two years' experience within the pharmaceutical/medical industry/CRO.
Willingness to undertake domestic and international travel as required by the project.
Email your resume to: [email protected]