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Scientist II, 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 protocols, while ensuring compliance with regulatory requirements and quality standards. Proficient in managing project timelines and collaborating effectively with stakeholders.
Highest-signal resume keywords
Clinical Regulatory Writing ExperienceClinical Study Reports (CSRs)Document Management Tools (Veeva, MS Office)Exceptional Writing and Editing SkillsLife Science Degree (Biology, Pharmacology, Biochemistry)
ATS Keywords
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Hard Skills
Clinical Regulatory WritingClinical Study Reports (CSRs)Regulatory Document AuthoringClinical Trial Data UnderstandingEditing and Proofreading
Soft Skills
Interpersonal SkillsAbility to Work IndependentlyTeam CollaborationAbility to Work Under PressureMeeting Deadlines
Tools & Technologies
VeevaMS Office
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryCRO IndustryRegulatory Submission DocumentsClinical Development Documents
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
- Incorporate reviewer feedback and manage version control across multiple stakeholders
- Document timelines and ensure projects are delivered on time and on budget
- Help shape Cardinal Health's first medical writing team in Ireland and establish new ways of working
Requirements
What you’ll need- Bachelor's or Master's degree in life science (e.g., biology, pharmacology, or biochemistry)
- 2-3 years of clinical regulatory writing experience within the pharmaceutical, biotechnology, or CRO industry
- Experience authoring and reviewing regulatory documents, Clinical Study Reports (CSRs), and protocols
- Ability to understand clinical trial data, methodologies, and complex research
- Exceptional writing, editing, and proofreading skills
- Ability to work independently and as part of a team
- Ability to work under pressure and meet challenging deadlines
- Excellent interpersonal skills
- English proficiency required
- Proficiency in document management tools such as Veeva and MS Office
Benefits
Comp & perks- Permanent role with long-term growth potential
- Inclusive workplace that values diversity of thought, experience and background
- Equal Opportunity employer