Principal Medical Writer

Act as medical writing lead on submission team or early development program. Author and give directions for preparing clinical and regulatory documents, including Investigator’s Brochures, Clinical Study Reports. direct the entire document portfolio required for a project (eg, an NDA submission or an early development program). Participate in planning for medical writing resources and contribute to the development of project timelines. Review work of other writers for accuracy, quality, focus, and adherence to format and stylistic. Facilitate document review meetings and discussions. n collaboration with medical writing and other functions, prepare internal guidelines for document preparation and templates for clinical documents that are consistent with EMA, FDA and ICH guidelines, and with electronic submission guidelines.

According to JobzMall, the average salary range for a Principal Medical Writer in 400 Connell Dr, Watchung, NJ 07069, USA is $115,000 to $145,000 per year. This range is based on the salaries of Principal Medical Writers in the area and is an estimate. The exact salary for any particular position may vary depending on the company, the individual's qualifications and experience, and other factors.

Celgene Corporation is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. Bristol Myers Squibb's $74 billion takeover of Celgene was pharma's defining mega-merger of 2019, and one of the largest in the industry's history.