Manager, FSP Medical Writing

Job Description: • Manage a team of internal writers serving as Functional Service Providers (FSPs) in a client-placement model, coordinate resources, and develop work plans that align with internal and external goals and timelines • Oversee quality performance of FSPs; ensuring that all clinical regulatory documents: • Comply with international, national, and pertinent local regulations • Adhere to SOPs and guidance documents (internal and/or external) • Are completed according to timelines • Ensure that all FSPs: • Have the qualifications, level of experience and scientific knowledge specified for assigned client projects • Have met all pre-employment reference and background checks • Are current on trainings required by the client and by Synterex and that all trainings are supported by proper documentation • Liaise with Executive Leadership team to report on and optimize staff utilization and other key performance indicators (KPIs); record and utilize metrics to inform KPIs • Support Medical Writing and Business Development leadership in preparation of work orders, budgets, invoicing, and forecasting • Coordinate with Business Operations to answer customer inquiries and enhance time reporting processes • Provide guidance and leadership for document development for regulatory writing deliverables, including organization, content, and resource requirements • Produce clinical protocols and amendments, clinical study reports, summaries of safety/efficacy, other regulatory documents (eg, annual reports, briefing documents), safety reports, patient narratives, and investigator brochures/updates as needed Requirements: • Undergraduate degree in a scientific or health-related field required • Minimum 5 years of clinical research/drug development experience in biotech, pharmaceutical, or contract research organization (oncology experience a plus). • Equivalent experience in a related medical field is acceptable. • Experience managing diverse teams preferred • Team-oriented, self-motivated, assertive, self-confident, and capable of working under minimal supervision • Ability to assess and coordinate resources and work effectively across multi-disciplinary work teams • Exceptional communication and interpersonal skills • Excellent organizational and project management skills to coordinate resourcing across multiple projects • Experience with regulatory documents (Module 2 summaries, IND, MAA, annual reports, ISE & ISS); writing nonclinical reports and tabulated summaries a plus • Proficient with Microsoft Word, Excel, Project, and PowerPoint • Working knowledge of GCP, 21 CFR, CTD, ICH guidelines/regulations, and the drug development process is required Benefits: Apply tot his job Apply To this Job