Our partner and client is a cutting-edge biotechnology company solving the biggest challenges for oncology patients through antibody therapeutics.  As they grow their team in the US, we are supporting them for a new Senior Manager of Medical Writing to join the Global Medical Writing team to be responsible for driving, developing, and writing clinical documents to support operational, medical, and regulatory activities across the client portfolio.  Our Writing Team is responsible for ensuring that scientifically robust messages and arguments are developed and conveyed consistently across documents.

The Right Talent:

BS Degree in a relevant area

7+ Years of Pharmaceutical or Biotechnology regulatory medical writing experience

Familiarity with all phases of the drug development process, clinical trials, CTA/IND submission, investigator brochures, clinical trial data collection, and results reporting

Experience authoring clinical trial protocols (Phase 1-3) and clinical components in regulatory filings (NDA,BLA,MAA)

Experience drafting and editing documents used to support clinical trial conduct and reporting, including clinical trial protocols, investigator’s brochures, clinical study reports, Health Authority briefing packages/ responses, and clinical CTD submission documents

Must work well in a cross-functional, matrice setting and a growing organization

Remote Opportunity located in the EST or CST zones