FREE ACCESS
5,000–10,000 jobs/day
See all jobs on JobTailor
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Medical Writing leadership, regulatory document preparation, and quality control processes, with a strong foundation in clinical trial methodologies and medical terminology. Proven ability to collaborate with cross-functional teams and manage complex projects within the pharmaceutical and CRO industries.
Highest-signal resume keywords
Medical Regulatory WritingClinical Protocol DevelopmentRegulatory Document SubmissionLeadership and ManagementAnalytical Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical WritingRegulatory Document PreparationClinical Trial ProcessAdvanced Word ProcessingAdobe ProDocument Management SystemsMedical TerminologyREMS KnowledgeKAB Regulatory ProgramsData Interpretation
Soft Skills
Leadership SkillsOrganizational SkillsAttention to DetailCommunication SkillsInterpersonal Skills
Certifications & Qualifications
Master's Degree in Biological SciencesDoctorate Degree in Biological Sciences
Industry Keywords
Pharmaceutical IndustryCRO IndustryClinical StudiesPhase 1 to IV StudiesSOPsProject ManagementBusiness DevelopmentRFIsRFPsTherapeutic Areas
About the role
Key responsibilities & impact- Provide leadership and management of Medical Writing group
- Lead programs and prepare Phase 1 through IV and post marketing regulatory documents including: clinical protocols and study reports, study synopses, IND, NDA and MAA submission documents, safety narratives, registry and observational study protocols and reports, risk evaluation and mitigation strategy (REMS) assessment reports, knowledge, attitude, and behavior surveys (KABS) reports, and abstracts/manuscripts for publication
- Ensure peer review and QC of regulatory documents for publishing according to standard operating procedures (SOPs)
- Participate in UBC and client project teams for project planning and development of timelines
- Coordinate/consult with other UBC departments such as SERRM, Data Management, Programming, Biostatistics, Quality Assurance, and Project Management on Medical Writing projects
- Lead preparation and review of departmental standard operating procedures (SOPs) to improve efficiencies and quality of processes
- Participate in requests for information (RFIs) and requests for proposals (RFPs) for business development opportunities
Requirements
What you’ll need- Master's or doctorate degree in biological sciences or equivalent
- 10-15 years of experience with at least 8 years’ experience in medical regulatory writing or equivalent within the pharmaceutical/CRO industry
- Wide breadth of experience in multiple therapeutics areas and phases of clinical studies
- Advanced word processing skills (Microsoft Word) and advanced Adobe Pro skills
- Familiarity with different document management systems
- Knowledge of medical terminology and understanding of the clinical trial process
- Knowledge of REMS and KAB regulatory programs preferred
- Ability to interpret clinical data and strong analytical skills and communicate to cross-functional teams
- Strong leadership and organizational skills
- Attention to detail/high degree of accuracy
- Strong communication and interpersonal skills
Benefits
Comp & perks- Health insurance
- Retirement plans
- Flexible work arrangements
- Paid time off
- Professional development