A prominent biotherapeutics and drug development company focused on developing innovative therapies for patients with debilitating diseases is looking for a Medical Writer to work remotely alongside the Thousand Oaks team. This role is responsible for the development of clinical and safety (pharmacovigilance) regulatory content and documents across the bio product pipeline. This position collaborates with a variety of functional areas to prepare, manage, and deliver documents and content covering all phases of clinical development in support of global regulatory filings.
- Prepares and manages the preparation of safety and clinical regulatory submission documents in compliance with global regulatory requirements, including but not limited to investigator's study reports, clinical summaries/overviews, brochures, study protocols, integrated reports, safety update reports, risk management plans, and contributes clinical/safety content to related regulatory documents.
- Initiates and oversees the document development process by gathering materials and developing scientifically rigorous content, and facilitating document review meetings and discussions as well as assuring adherence to standards of electronic submission.
- 2+ years of experience with a Bachelor's Degree in a relevant scientific discipline.
- Experience in regulatory medical writing in a biopharmaceutical environment and/or other scientific/technical writing.
- Experience in writing clinical and safety regulatory documents intended for international use, based on knowledge of international regulations and guidelines governing the documents.
- Working knowledge of AMA Style guide and clinical research terminology.
- Strong written communication skills including the ability to independently interpret and summarize complex results.
- Track record of successfully meeting tight deadlines.
- Proficiency in editing and expertise in Microsoft Office and Acrobat applications.
This is a remote 3+ month contract with possible extensions, and full benefits provided by EPM Scientific.