This position is responsible for writing and reviewing a wide range of document types, e.g., guidance documents, SOPs, and successful pivotal clinical trial protocol development, etc. Expert knowledge of device and pharmaceutical research practices, device and pharmaceutical regulatory requirements, Quality Management Systems, and post market surveillance is needed. Must accurately interpret and efficiently convey scientific information in an appropriately formatted manner within deadlines and work in a professional and collaborative manner.
- Leads medical writing activities in preparation of regulatory and clinical documents required to support Innovenn’s client’s device/drug development and registration activities.
- Serves as the primary medical writing representative on assigned project teams and closely collaborates with personnel from clients’ clinical, regulatory and scientific departments, as required.
- Writes, edits, and reviews regulatory and clinical documents which may include standard operating procedures, clinical study reports, study protocols, investigator brochures, informed consent forms, clinical data summaries and other medical/regulatory documents including regulatory summary documents (e.g., IND/NDA documents).
- Develops, implements, and manages templates and documentation formatting required for standardization of regulatory & clinical documentation to support Innovenn’s client’s development and registration activities.
- Coordinates and conducts interdepartmental team reviews and sign-off of document deliverables according to Innovenn’s guidelines/SOPs including distributes drafts, chairs review meetings, incorporates revisions, documents key project events.
- Coordinates and manages documents to produce submission ready content (SRC) for clients.
EDUCATION, SKILLS, AND EXPERIENCE REQUIRED:
BA or BS degree in health-related discipline. Ten (10) years of professional scientific and/or pharma medical writing experience with experience in clinical drug development, diagnostic test development, and device approval process (e.g., multiple 510K application). Advanced understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology required.
Must demonstrate excellent problem-solving skills and attention to detail; proven ability to understand and interpret data/information and its practical application, excellent written and verbal communication skills and must be able to demonstrate excellent scientific writing skills and ability to adapt style and content. Must have excellent technical editing and QC skills with reports, papers, proposals, etc., and efficiently discuss the same with other scientists, engineers, and customers.
Advanced computer skills to include MS Office with ability to search and scan various internal and external databases.