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Senior Strategic Medical Writer
Lifelancer. Lead and write clinical and regulatory documents for drug and/or device development in support of company objectives .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in writing and managing clinical and regulatory documents in compliance with US and international regulations, while effectively communicating complex scientific information to diverse stakeholders. Proven ability to coordinate cross-functional teams and drive submission objectives within project timelines.
Highest-signal resume keywords
Clinical Document WritingRegulatory Document PreparationKnowledge of ICH GuidelinesProject Management SkillsCommunication 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
Clinical WritingRegulatory WritingData AnalysisMedical TerminologyBiostatisticsDrug Development KnowledgeStudy Design UnderstandingGCP ComplianceEU Device WritingFamiliarity with CONSORT and PRISMA
Soft Skills
Organizational SkillsTime ManagementProblem-Solving SkillsCollaborationCommunication
Industry Keywords
Bio-Pharmaceutical IndustryGlobal PharmaBiotechLife ScienceHealthcare AuthorityTherapeutic AreasSubmission StrategiesQuality ControlInspection-Ready ApproachCross-Functional Teams
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead and write clinical and regulatory documents for drug and/or device development in support of company objectives
- Prepare clinical and regulatory documents needed for AbbVie drug and/or device development
- Draft materials with moderate autonomy and incorporate review by subject matter experts and senior writers
- Develop knowledge and understanding of submission strategies
- Coordinate review, approval, and quality control across functions involved in clinical and regulatory projects
- Arrange and conduct team review meetings
- Produce and maintain high-quality, compliant clinical and regulatory documents within project timelines
- Develop project management knowledge and take greater responsibility for driving submission objectives
- Apply US and international regulations, requirements, and guidelines to regulatory documentation
- Participate in tactical process improvements
- Identify and propose solutions to issues arising during the writing process, resolving or escalating as appropriate
- Work with leadership and R&D Quality Assurance to address inquiries and draft responses in support of an inspection-ready approach
Requirements
What you’ll need- Minimum of 4+ years of bio-pharmaceutical industry experience in global pharma, biotech, life science, or healthcare authority delivering medicines/therapies to a broad market across various therapeutic areas
- Bachelor's Degree or higher required; scientific discipline preferred
- Outstanding written and oral communication skills
- Comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas
- Proficiency in assimilating and analyzing complex data
- Experience writing and editing clinical and regulatory documents following guidelines and regulations, such as ICH guidelines, GCP, and other regulatory requirements
- Familiarity with CONSORT and PRISMA guidelines
- Understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
- EU and US device writing experience is a plus
- Excellent writing skills
- Ability to communicate complex scientific and medical information to various stakeholders
- Ability to oversee multiple projects simultaneously and collaborate with cross-functional teams
- Strong organizational, time management, and problem-solving skills
- Ability to sit continuously for prolonged periods, more than 2 consecutive hours in an 8-hour day
Benefits
Comp & perks- Paid time off, including vacation, holidays, and sick leave
- Medical, dental, and vision insurance
- 401(k)
- Eligibility to participate in long-term incentive programs