This is a permanent position.
Responsibilities:
Writing of documents for submission to global regulatory agencies, including clinical study reports (CSRs), clinical protocols, clinical safety and efficacy summaries (ISSs/ISEs), investigator's brochures (IBs), and manuscripts/posters, as necessary
Cross-functional interactions with Medical Director, Biostatistics, Drug Safety, Regulatory Affairs, and Clinical Operations for key regulatory documents
Distribute drafts, incorporate comments and manage the approval and archiving of final documentation
Create project plans and lead the team responsible for the on-time completion of documents written according to regulatory requirements
Requirements:
Bachelors degree in Science, advanced degree preferred
3+ yrs experience writing regulatory documents for a pharmaceutical or biotechnology company
Oncology experience preferred, a HUGE plus
Hands-on experience of current global regulatory requirements, including e-submission requirements of clinical regulatory documents
Contact:
The jobs listed in the Biotech Ink Insider weekly newsletter come to Susan Caldwell mostly by word-of-mouth and contact with hiring managers and recruiters. 