PHARMAFull-time
Medical Writer, Clinical Development
By Admin · Medical & Scientific Writing
AHMEDABAD (IN)ONSITEPOSTED: 9/12/2026
PHARMAFull-time
HIRING ORGANIZATIONNOT SPECIFIEDPharmaceuticals
ROLE OVERVIEW
Author, review, and manage high-quality clinical and regulatory documentation that supports global clinical development programs, clinical trial execution, and regulatory submissions.
ROLE DEFINITION & RESPONSIBILITIES
- •Author and compile clinical trial and regulatory documents
- •Ensure scientific accuracy, consistency, and compliance with ICH-GCP, FDA, EMA, and other applicable requirements
- •Collaborate with cross-functional teams to gather, interpret, and present clinical data
- •Manage document review cycles, stakeholder feedback, and version control
- •Support health authority submissions and responses to regulatory queries
- •Develop and maintain document templates, style guides, and writing standards
Reporting Hierarchy: Reporting structure not specified in the provided posting; Collaborates with Clinical Operations, Medical Affairs, Biometrics, Pharmacovigilance, Regulatory Affairs, and external partners
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree in a science field
- 5+ years of experience in Regulatory Affairs, Technical Writing, Pharmaceutical industry, or related field
- Strong understanding of clinical research and drug development
- Knowledge of ICH-GCP and regulatory guidelines
- Excellent scientific writing and communication skills
- Proficiency with Microsoft Office and document management systems
PREFERRED QUALIFICATIONS
- •Advanced degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or related field
- •Master's, PharmD, or MD
- •Direct medical writing experience in pharmaceutical, biotechnology, or CRO industry
- •Strong project management and cross-functional collaboration skills
REQUIRED VERIFIED SKILLS
Medical writing
clinical research
clinical development
ICH-GCP
FDA requirements
EMA requirements
clinical study protocols
Clinical Study Reports
Investigator's Brochures
informed consent documentation
regulatory submissions
safety narratives
document management
version control
scientific writing
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Professional development; cross-functional collaboration; exposure to clinical development and regulatory programs
No salary or bonus/equity information is disclosed in the provided posting, so compensation figures are left blank.
ORGANIZATION CONTEXT & CULTURE
Hiring company is not identified in the provided job description.
TEAM SIZE: Not specified
INDUSTRY: Pharmaceuticals
Culture: The role emphasizes scientific rigor, attention to detail, quality, compliance, cross-functional collaboration, and operational excellence.
EXPECTED CAREER ROADMAP
Potential progression includes Senior Medical Writer, Lead Medical Writer, Principal Medical Writer, or broader Clinical Development and Regulatory Writing leadership positions, subject to organizational structure and performance.
APPLICATION ADVISORY
Highlight 5+ years of relevant pharmaceutical, regulatory affairs, technical writing, or medical writing experience; showcase experience with protocols, CSRs, IBs, regulatory submission documents, and safety narratives; emphasize ICH-GCP knowledge and FDA/EMA regulatory familiarity; demonstrate strong document management and cross-functional communication skills.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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