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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory writing and document management within the Biotech and Pharmaceutical industries, with a strong focus on leading complex product submissions and mentoring junior writers.
Highest-signal resume keywords
Regulatory WritingClinical Study ReportsBiologics License ApplicationsMedical Writing ExperienceMentoring Junior Writers
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Submission DocumentsClinical Overview AddendaECTD Module 2 Clinical Summary DocumentsPediatric Investigation PlansProtocol AmendmentsInformed Consent FormsResponses to QuestionsDocument TimelinesStandard Operating ProceduresComplex Product Submissions
Soft Skills
LeadershipSupervisionCollaborationMentoringInitiative
Industry Keywords
Regulatory AffairsBiotech IndustryPharmaceutical IndustryEvidence Generation TeamGlobal Regulatory TeamLabel Working Group
About the role
Key responsibilities & impact- Serve as the functional area lead on product teams
- Lead writing activities for complex product submissions
- Author or oversee regulatory submission documents, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
- Conduct formal review and approval of authored documents following applicable standard operating procedures
- Lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
- Serve as functional area lead on Global Regulatory Team, Evidence Generation Team, Global Safety Team, and Label Working Group
- Provide functional area input for Global Regulatory Plan and team goals
- Supervise contract and freelance writers and mentor junior medical writers
- Lead departmental and cross-departmental initiatives
- Generate document timelines
Requirements
What you’ll need- Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience
- Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
- 5+ years of experience in medical writing in the Biotech/Pharmaceutical industry
Benefits
Comp & perks- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
- Career development opportunities
- Work/life balance