Proclinical is currently recruiting for a Medical Affairs Project Manager with a pharmaceutical company located in Cambridge, MA.
- Ability to manage all aspects of SRC/FRC meetings: prepare the agenda, distribute meeting materials, manage presenters, raise pertinent questions, draft/distribute meeting minutes.
- Proactively manage IST/IME applications from submission through closeout
- Metrics reporting: prepare and track cycle times and make recommendations for process changes
- Work with Regulatory Affairs to generate cross-reference letters and ensure all regulatory documents for studies are in place
- Work with Legal to generate contracts and Confidentiality Disclosure Agreements
Skills and Requirements:
- Bachelor's Degree in an area of science with 4+ years of pharma/biotech industry experience in medical affairs or clinical trials operations
- Experience in the operational management of ISTs and IME/CME grants
- Understanding of the compliance rigor applied to IST and IME/CME grants
- Track record of successfully managing multiple complex projects from start to completion
If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 267-297-3257.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.