Technical Writing Consultant II
Location: Monroeville, PA
Duration: 12 Months
Generate comprehensive reports (formal evidence dissemination) that demonstrate the safety and performance of medical products which are part of the current or planned Philips Respironics, Sleep and Respiratory Care (SRC) product portfolio:
• Draft documents as required for domestic and international Regulatory submissions
• Assists in the planning, development, and execution of Clinical Evaluation Plans (CEPs) and Reports (CERs)
o Conducts reproducible, thorough, and objective literature searches. Evaluates the contribution of the clinical literature to establish performance and safety of therapeutic and diagnostic medical devices (products).
o Extracts and relevant clinical data and creates tables for data analysis and presentation. Reviews product risk information, device labeling, and product claims in light of device safety and performance information.
• Experience planning and executing internet literature searches using databases such as PubMed and EMBASE.
• Strong knowledge of MEDDEV 2.7.1 Rev. 3 and Rev. 4 and EU MDR
• Experience in updating CERs from MEDDEV 2.7.1 Rev. 3 to Meddev 2.7/1 Rev
• Understanding of research methodology and regulatory requirements
• Understanding of diagnosis and management of the conditions where products are applied
Experience: Minimum 15 years professional experience in the applicable role. Expert and technical lead with proven experience.
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.