Synterex Inc is hiring: Manager, FSP Medical Writing in Boston

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 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

For further information or to apply, please reach out to careers@synterex.com.

Synterex 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.

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