Manager, FSP Medical Writing
Job Description:
• 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
Benefits:
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• 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
Benefits:
Apply tot his job
Apply To this Job