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Scientist III, Clinical Regulatory Writing
Cardinal Health. Author, review, and edit clinical regulatory documents, primarily Clinical Study Reports (CSRs), clinical study protocols, protocol amendments, and related clinical development documents .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical regulatory writing, including authoring and reviewing Clinical Study Reports (CSRs) and regulatory submission documents while ensuring compliance with ICH, FDA, and EMA guidelines. Proven ability to manage multiple projects and collaborate effectively with cross-functional teams in the pharmaceutical and biotechnology sectors.
Highest-signal resume keywords
Clinical Regulatory WritingClinical Study Reports (CSRs)ICH GuidelinesRegulatory Submission RequirementsStakeholder Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Regulatory WritingAuthoring Regulatory DocumentsReviewing Clinical Study ProtocolsStatistical Analysis Plans (SAPs)CTD Module 2 SummariesPediatric Investigation PlansSafety UpdatesHealth Authority ResponsesClinical Drug Development ProcessVersion Control
Soft Skills
Strong Communication SkillsCross-Functional CollaborationStakeholder ManagementProject ManagementScientific Content Expertise
Industry Keywords
Pharmaceutical IndustryBiotechnologyCRO IndustryGCPFDAEMAClinical OperationsBiostatisticsData ManagementPharmacovigilance
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Author, review, and edit clinical regulatory documents, primarily Clinical Study Reports (CSRs), clinical study protocols, protocol amendments, and related clinical development documents
- Support development of CTD Module 2 summaries, Clinical Overviews, Investigator Brochures, briefing books, responses to Health Authority questions, safety updates, Pediatric Investigation Plans, and other regulatory submission documents
- Ensure deliverables meet regulatory requirements, internal quality standards, client expectations, and project timelines
- Provide scientific and strategic content expertise and guidance on regulatory requirements to study and submission teams
- Collaborate with Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Medical Affairs, Regulatory Affairs, and other cross-functional stakeholders
- Contribute to planning data analyses and presentation strategies for CSRs, including reviewing Statistical Analysis Plans (SAPs)
- Partner with Documentation Specialists and project teams to produce final documents, manage review cycles, incorporate feedback, maintain version control, and deliver submission-ready documents
- Serve as a subject matter expert in clinical regulatory writing and ensure compliance with ICH, FDA, EMA, and other global regulatory guidelines
Requirements
What you’ll need- Bachelor's, Master's, PharmD, or PhD in Pharmacy, Pharmacology, Life Sciences, Biomedical Sciences, or a related scientific discipline
- 4+ years of clinical regulatory writing experience within the pharmaceutical, biotechnology, or CRO industry
- Significant hands-on experience authoring and reviewing regulatory documents, Clinical Study Reports (CSRs), and protocols
- Strong understanding of the clinical drug development process and regulatory submission requirements
- Experience working in a pharmaceutical environment or a background in pharma, clinical, or scientific areas is strongly preferred
- Proven ability to interpret and communicate complex clinical and scientific information clearly, concisely, and compliantly
- Working knowledge of ICH guidelines, GCP, FDA, EMA, and global regulatory requirements
- Ability to independently manage multiple writing projects and meet demanding timelines
- Strong stakeholder management and cross-functional collaboration skills
- Excellent written and verbal communication skills in English
Benefits
Comp & perks- Permanent role with long-term growth potential
- Inclusive workplace valuing diversity of thought, experience, and background
- Equal Opportunity employer