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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical researchdrug developmentregulatory writingclinical protocolsclinical study reportssafety reportsnonclinical reportstabulated summariesproject managementresource coordination

Soft Skills

team-orientedself-motivatedassertiveself-confidentcommunication skillsinterpersonal skillsorganizational skillsleadershipability to work under minimal supervisionability to assess resources