ClinForce is currently seeking a Medical Writer for Wilmington, DE.
Successful candidate will provide medical communication expertise in the production of regulatory documentation (including regulatory dossiers, Investigator Brochures, protocols, FDA Briefing documents) across product life cycle to ensure timely registration and to sustain competitive products in the US. Other responsibilities are as follows:
- Prepare regulatory documents (Investigator Brochures, clinical trial reports, NDA sections) according to agreed standards.
- Critically assesses, interprets, and accurately summarizes medical data.
- Contribute to the underlying strategy for achieving the most persuasive and effective presentation of data to the FDA to help ensure the optimal label for a product.
- Promote and exploit global working in the preparation of clinical contributions to regulatory dossiers.
- Provide innovative advice and guidance on planning and resource forecasting for dossier and document production to enable competitive deadlines.
- Interpret and monitor current and emerging communication issues and guidelines.
- Manage contract resources through the effective use of project management skills to ensure the delivery of quality documents.
Experience/Minimum Requirements: At least 2 years experience in the clinical research industry and medical writing experience
Education/Degree: BA/BS Degree
Interested candidates should send resumes to response@clinforce.com or fax to 866-941-1400 with 'CF3019 MON' in the subject line.
