The Director of Medical Writing will be responsible for develop strategy for the content of documents to support clinical development and applicable sections of submissions to regulatory agencies (e.g., Protocols, Amendments, Investigator' s Brochure, Clinical Study Reports, IND Annual Reports, Briefing Documents, CMC updates, etc). Key responsibilities will include the management of the medical writing team, leading the Medical Writing function and overseeing the writing, preparation and editing of documents, ensuring that methods, results, and conclusions are appropriate.
The ideal candidate will have proven skills in writing and editing documents for regulatory submissions and publications, including interpretation and summarization of complex clinical data across multiple studies and phases. As well as proven management and organizational skills, including ability to understand, organize and supervise staff to work concurrently on several projects. Strong interpersonal skills and computer literacy are a must.
Preferred skill set includes a BS/MS/PhD in a life science discipline; 3-5 years in the pharmaceutical and/or biotechnology industries in regulatory medical writing including prior MAA / NDA. ECTD experience is preferred.
If you have any interest in further information regarding this opportunity, please forward your resume along with contact information to:
Associate Director, Recruitment
Delta Pharma, a Randstad company
Four Parkway North, Suite 120
Deerfield, IL 60015
T 262 302 0352
F 847 317 9543
www.delta-pharma.com or www.delta-pharma/jobs