Medical Writer - Permanent Opportunity
Our client is a growing biopharmaceutical company located in Florida. They are seeking a Medical Writer who will serve as lead for all clinical/nonclinical regulatory medical writing. Must be a leader in a fast-paced, collaborative, global biopharma environment.
The successful candidate will be responsible for leading the Company’s NDA in Common Technical Document (CTD) format: Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE), Clinical/Nonclinical Written and Tabulated Summaries and Overviews. This role will work effectively with cross-functional groups. Other clinical/non-clinical writing responsibilities may include Clinical Study Reports, ICFs, INDs, IMPDs, Investigator Brochures, as well as clinical and nonclinical publications (e.g. abstracts, posters, and manuscripts).
The ideal candidate will have:
° BS/BA, MS/MPH/MA, or PhD/PharmD in a scientific or medical discipline with a minimum of 10 years of medical writing/editing experience in the pharmaceutical/biotechnology industry or CRO environment. Advanced degree preferred
° Proven ability to lead medical writing for all clinical/nonclinical regulatory documents- must have strong NDA experience (i.e., ISSs, ISEs, Clinical/Nonclinical Summaries and Overviews.
° Proven ability to understand and summarize clinical/nonclinical data and illustrate scientific and medical data for regulatory submissions and filings
° Must have thorough knowledge of FDA and ICH Guidelines associated with clinical/nonclinical sections of NDAs, INDs, IMPDs and other regulatory documents (CSRs, IBs, and clinical study protocols)
This is a great opportunity to get in on the ground floor of this exciting company. Well compensated with relocation assistance if needed.
My client is highly motivated to fill this position as soon as possible. If you meet the above requirements please send me your résumé today. We will set up a time to discuss your career goals, experience and if this position is the right fit for you.
Keywords: NDA, IND, IMPD, CSR, IB, clinical study protocols, FDA, ICH, ISE, ISS, CTD, medical writer, pharmaceutical, Oncology