Proclinical Staffing
Los Angeles, CA, USA
Proclinical is seeking a remote Associate Director, Medical Writing for a global healthcare organization.
The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format.
Must be eligible to work in the US.
Job Responsibilities:
Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians,...