Manager, FSP Medical Writing

Synterex, Inc. is a global consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval. Synterex is seeking an organized, motivated, and collaborative individual for our medical writing team. The Manager, FSP Medical Writing will report to the Executive Director of Medical Writing and Quality Assurance and will be responsible for the coordination, management, and growth of FSP Medical Writing team members and vendors/contractors, as applicable. The Manager, FSP Medical Writing will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management, in planning, preparing, oversight, and/or review of high-quality clinical and regulatory documents (protocols, study reports, sections of marketing applications in CTD format, etc.).This is a full-time position.Location Fully remote. Essential Duties & Responsibilities 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 timelinesOversee quality performance of FSPs; ensuring that all clinical regulatory documents:Comply with international, national, and pertinent local regulationsAdhere to SOPs and guidance documents (internal and/or external)Are completed according to timelinesEnsure that all FSPs:Have the qualifications, level of experience and scientific knowledge specified for assigned client projectsHave met all pre-employment reference and background checksAre current on trainings required by the client and by Synterex and that all trainings are supported by proper documentationLiaise with Executive Leadership team to report on and optimize staff utilization and other key performance indicators (KPIs); record and utilize metrics to inform KPIsSupport Medical Writing and Business Development leadership in preparation of work orders, budgets, invoicing, and forecastingCoordinate with Business Operations to answer customer inquiries and enhance time reporting processesProvide guidance and leadership for document development for regulatory writing deliverables, including organization, content, and resource requirementsProduce 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 neededRequirements Undergraduate degree in a scientific or health-related field requiredMinimum 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 preferredTeam-oriented, self-motivated, assertive, self-confident, and capable of working under minimal supervisionAbility to assess and coordinate resources and work effectively across multi-disciplinary work teamsExceptional communication and interpersonal skillsExcellent organizational and project management skills to coordinate resourcing across multiple projectsExperience with regulatory documents (Module 2 summaries, IND, MAA, annual reports, ISE & ISS); writing nonclinical reports and tabulated summaries a plusProficient with Microsoft Word, Excel, Project, and PowerPointWorking knowledge of GCP, 21 CFR, CTD, ICH guidelines/regulations, and the drug development process is requiredFor further information or to apply, please reach out to [email protected] provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Created: 2026-04-03