Senior Manager, Regulatory and Medical Writing
New
J
JobgetherClinical Research
Fully remote opportunity within the United States.Full-TimeManager
Salary not disclosed
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Job Details
- Experience
- At least 6 years of experience in Regulatory and Medical Writing or a closely related field
- Required Skills
- GCPPeople ManagementMS Office
Requirements
- College degree in a scientific, medical, clinical, or related discipline (Master’s degree or PhD preferred).
- At least 6 years of professional experience in Regulatory and Medical Writing.
- Proven direct experience managing, mentoring, and developing Medical Writing professionals.
- Strong understanding of regulatory requirements including FDA, GCP, and 21 CFR Part 11.
- Hands-on knowledge of clinical trials, pharmaceutical development, and the drug development lifecycle.
- Demonstrated expertise in complex regulatory and clinical document types.
- Proficiency with MS Office and various medical writing and project technologies.
- Strong analytical, organizational, and stakeholder-management skills.
- Familiarity with ISO 9001 and ISO 27001 standards within a life sciences environment.
- Comfortable adopting and supporting emerging technologies, such as AI-assisted authoring tools.
- Previous experience within a CRO is preferred.
Responsibilities
- Serve as a senior subject matter expert in regulatory and medical writing.
- Provide guidance and mentorship to medical writers and managers to support their professional development.
- Supervise assigned team members, including work allocation, progress reviews, and performance management.
- Lead or contribute to departmental initiatives and strategic projects.
- Advise teams on writing styles, document requirements, and quality expectations for complex regulatory deliverables.
- Support colleagues in the use of medical writing tools, quality control processes, and emerging technologies like AI-assisted authoring.
- Manage project lifecycles from initiation to completion while coordinating stakeholders and deliverables.
- Assess and mitigate project risks while maintaining client relationships and clear communication.
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