Manager, Medical Writing
Synterex - Andover, Massachusetts, us, 01810Work at Synterex
Overview
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Overview
Synterex is seeking an organized, motivated, and collaborative individual for our medical writing team.The Manager, 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 Medical Writing team members and vendors/contractors. The Manager, Medical Writing will partner cross-functionallywith client teams inClinical 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: Hybrid; must be able to attend occasional client meetings on site as needed
Essential Duties & ResponsibilitiesManage direct reports, coordinate resources, and develop work plans that align with internal and external goals and timelinesOversee quality output of deliverables delegated to Medical Writing personnel and vendors/contractorsEnsure 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 timelinesLiaise 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 requirementsEnsure quality and consistency of style, format, and content for all documentsMay assist in the planning, writing, and assembly of clinical protocols and amendments, clinical study reports, summaries of safety/efficacy, other regulatory documents (annual reports, briefing documents), safety reports, patient narratives, and investigator brochures/updates as needed
RequirementsUndergraduate degree in a scientific or health-related field requiredMinimum 3 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 required
For further information or to apply, please reach out to careers@synterex.com. If anyone tries to contact you that does not come from a synterex.com email address or our HR system BambooHR, please delete and disregard the message as phishing scams are at an all-time high.
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