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    Manager Medical Writing

    Synterex
    3+ years
    Not Disclosed
    Boston
    10 July 19, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Manager, Medical Writing

    Company: Synterex, Inc.
    Location: Hybrid; must be able to attend occasional client meetings on site as needed
    Type: Full-time

    About Synterex, Inc.:

    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, focusing on providing clear, concise, accurate, and fully compliant documentation from early drug development through post-approval.

    Position Overview:

    The Manager, Medical Writing will report to the Executive Director of Medical Writing and Quality Assurance. This role is responsible for the coordination, management, and growth of Medical Writing team members and vendors/contractors. The position involves partnering cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to plan, prepare, oversee, and review high-quality clinical and regulatory documents.

    Essential Duties & Responsibilities:

    • Team Management:

      • Manage direct reports, coordinate resources, and develop work plans aligning with internal and external goals and timelines.
      • Oversee quality output of deliverables delegated to Medical Writing personnel and vendors/contractors.

    • Regulatory Compliance:

      • Ensure all clinical regulatory documents comply with international, national, and pertinent local regulations.
      • Adhere to SOPs and guidance documents (internal and/or external).
      • Ensure documents are completed according to timelines.

    • Cross-functional Collaboration:

      • Liaise with Executive Leadership to report on and optimize staff utilization and other key performance indicators (KPIs).
      • Support Medical Writing and Business Development leadership in preparing work orders, budgets, invoicing, and forecasting.
      • Coordinate with Business Operations to answer customer inquiries and enhance time reporting processes.

    • Document Development:

      • Provide guidance and leadership for document development for regulatory writing deliverables, including organization, content, and resource requirements.
      • Ensure quality and consistency of style, format, and content for all documents.

    • Additional Responsibilities:

      • Assist in planning, writing, and assembling 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.

    Requirements:

    • Education:

      • Undergraduate degree in a scientific or health-related field required.

    • Experience:

      • Minimum 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 preferred.

    • Skills:

      • 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.

    Application Process:

    For further information or to apply, please reach out to careers@synterex.com. Please disregard any communication that does not come from a synterex.com email address or our HR system BambooHR as it may be a phishing scam.

    Equal Employment Opportunity:

    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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