Location: Fremont CA
Duration: 6 Months+
Education: Bachelors/Masters in a scientific/technical discipline or equivalent; advance degree (M.S., Ph.D.) desired, experience in pharmaceutical, biological, or medical device development
Experience writing regulatory submissions such as NDAs/INDs,BLAs , Strong knowledge of FDA, ICH, ands GCP guidelines, Regulatory/Clinical writing experience
Responsible for Regulatory/Clinical writing assignments, Support the writing of CSRs, Protocols, IBs, Summaries of Safety and Efficacy
Responsible for the preparation of documents across all phases of clinical development, Contribute to clinical studies across several therapeutic areas.
Responsible for the preparation of documents across all phases of clinical development, Contribute to clinical studies across several therapeutic areas, Assist with documentation for pre-submission and submission packages, as required.
Develop, maintain and update templates for clinical documents including protocols, clinical study reports, investigational brochures, Integrated Summaries, literature reviews, and associated documents up to and including regulatory dossier to standardize the development process across disciplines.
Collect data by interviewing technical and process specialists, researching written material, attending training and demonstrations, using products, and observing users.
Independently synthesize and describe complex scientific data, and be well versed in scientific terminology, principles, and publishing standards. Generate documents that meet appropriate quality standard, to support formal verification and validation activities.
Lead and implement changes to improve the collaborative document creation process.