We're looking for a Medical Writing Director, working in the Biotechnology/Medical Devices industry in Redwood City, California, United States.
Works cross-functionally with internal customers and stakeholders to develop, implement and maintain a standardized document development process for clinical and regulatory documents.
Directs, authors, edits and provides input to clinical documents, documents required for regulatory submissions to the health authorities, presentations, posters, publications and regulatory fulfillment.
Authors/edits and/or directs the development of pre-clinical documents.
Manages external resources in support of the Medical Writing requirements.
We are offering Competitive Compensation and Benefits.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Advanced degree (MS, RN, PharmD or doctorate in a scientific or medical field)
At least 10 years in medical writing experience in the pharmaceutical/biotech industry
A minimum of 10 years experience of relevant experience in biotech/pharmaceutical company required, in the medical writing role, including participation in submission to the US FDA (IND, BLA) and EMA (MAA)
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.