PHARMAFull-time
PK Medical Writer
By Admin · Medical & Scientific Writing
BANGALORE (IN)REMOTEPOSTED: 9/12/2026
PHARMAFull-time
HIRING ORGANIZATIONICONContract Research Organization (CRO) / Clinical Research / Healthcare Services
ROLE OVERVIEW
Develop and deliver high-quality Clinical Pharmacology & Pharmacometrics documents, including population PK/PD plans and reports, CSRs, protocols, and regulatory clinical documents. The role supports clinical research projects through scientific writing, document coordination, quality control, and cross-functional collaboration.
ROLE DEFINITION & RESPONSIBILITIES
- •Develop clear and concise CSRs, protocols, investigator brochures, summaries, and other scientific documents
- •Prepare Clinical Pharmacology & Pharmacometrics documents including population PK/PD plans and reports
- •Drive document preparation from statistical output review through drafting, distribution, review, and comment resolution
- •Provide scientific and medical writing consultancy to project teams
- •Ensure deliverables comply with client SOPs, WIs, policies, regulatory requirements, and ICH-GCP
- •Maintain inspection-ready documentation and quality standards
- •Coordinate central planning of population PK/PD writing and QC deliverables
Reporting Hierarchy: Reports to the relevant Medical Writing/Clinical Pharmacology & Pharmacometrics project leadership; Collaborates with clinical pharmacology and pharmacometrics leaders, statisticians, project teams, and reviewers
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Advanced degree in Life Sciences, Pharmacy, Medicine, or related field
- Minimum 3-5 years of medical writing experience in pharmaceutical, biotechnology, or CRO industry
- Ability to interpret and summarize clinical trial data, scientific research findings, and statistical analyses
- Excellent scientific writing, editing, and proofreading skills
- Strong understanding of ICH-GCP, FDA, and EMA requirements
- Ability to manage multiple projects and collaborate with cross-functional teams
PREFERRED QUALIFICATIONS
- •Experience with Clinical Pharmacology & Pharmacometrics documentation
- •Experience preparing CSRs for Phase 1 or clinical pharmacology trials
- •Experience with Module 2.7.1 and 2.7.2 documents
- •Experience interacting with regulatory agencies
REQUIRED VERIFIED SKILLS
medical writing
clinical pharmacology
pharmacometrics
population PK/PD
clinical trial data interpretation
scientific writing
CSR writing
protocol writing
ICH-GCP
FDA requirements
EMA requirements
regulatory documentation
proofreading
quality control
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Bonus & Equity: Competitive base salary and performance related incentives
Benefits: Health and wellbeing programmes including medical, dental, and vision coverage where applicable; retirement and pension plans; life assurance and disability coverage; employee assistance programmes; learning and development opportunities
The posting does not disclose a specific salary range. It states that the package includes competitive base salary and performance-related incentives, with benefits varying by role and location.
ORGANIZATION CONTEXT & CULTURE
ICON is a global healthcare intelligence and clinical research organisation focused on helping bring new medicines and treatments to patients faster.
TEAM SIZE: 40,000+ employees
INDUSTRY: Contract Research Organization (CRO) / Clinical Research / Healthcare Services
Culture: ICON emphasizes integrity, collaboration, agility, inclusion, scientific quality, and patient-focused clinical research.
EXPECTED CAREER ROADMAP
The role can progress toward Senior Medical Writer, Principal/Lead Medical Writer, Medical Writing Project Lead, or broader clinical development and regulatory documentation leadership roles within a CRO or pharmaceutical environment.
APPLICATION ADVISORY
Highlight 3-5 years of medical writing experience, advanced Life Science/Pharmacy/Medicine education, CSR and protocol writing, PK/PD knowledge, clinical data interpretation, and familiarity with ICH-GCP/FDA/EMA requirements. Showcase examples of managing review cycles, resolving comments, and delivering inspection-ready documents.
RECOMMENDED TRAINING
1/3
READY TO SUBMIT?
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