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 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 [email protected].

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.