Contract/40 hours per week (6 months +), Montvale, NJ
My client is experience tremendous and continued growth and is looking to hire 5-10 Principal Medical Writers who can work independently writing CSRs, CSPs, IBs, and Clinical Summaries. The ideal candidate would contribute to the document strategy in a therapeutic area, and can lead the Medical Writing effort in a clinical filing. Ensures adherence to regulatory guidelines, and works with senior members of the department to help set department document standards. Helps to coordinate the efforts of the consultant writers and vendors.
Essential Duties and Responsibilities include, but are not limited to the following:
*As the Medical Writing Lead, will provide guidance to the Medical Writers and Study Team for the content, format and organization of clinical filings.
*Working with the clinical team, writes the following documents:
Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports, Investigator brochures, Clinical Summaries and other documents, as needed.
*Review documents related to the CSR, such as SAP, draft TFLs, ensuring that they provide the data necessary for an appropriate CSR.
*Responsible for tracking all documents in a therapeutic area.
*Ensure adherence to regulatory guidelines and works with senior members of the Medical Writing staff to help produce department guidelines, templates, standard timelines and SOP’s.
*Liaise with Study Director and/or Medical Monitors to shape and review content of the documents.
*Resolve issues and escalates problems, as necessary.
REQUIREMENTS – QUALIFICATIONS: Principal Medical Writer
*At minimum, a Bachelor’s degree (BS) from an accredited college or university, and 6 years of medical writing experience (CSR’s, CSP’s, IB, and Clinical Summaries).
*Experience leading NDA/BLA filings and some management experience.
*EMEA filing experience a plus.
*Strong knowledge of the clinical research process and regulations/guidelines required.
*Must have strong organizational, interpersonal, leadership, and communication skills.
*Must be able to communicate effectively in large or small group settings.
*Effective influence and relationship management skills required.
*Working knowledge of one or more EDM systems.
Contact Joan Tannenbaum, email@example.com