Synterex

• 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