Senior Medical Writer (Publication Writing) – Gurugram, India (Hybrid) | 3–5 Years Experience Required
Location: Gurugram, India (Hybrid)
Job ID: 25104931
Employment Type: Full-Time
Experience Required: 3–5 years in Medical Writing (Publication & Regulatory Writing)
A leading global biopharmaceutical solutions organization is seeking an experienced Senior Medical Writer – Publication Writing to lead high-quality scientific and regulatory documentation projects. This hybrid opportunity in Gurugram is ideal for professionals with proven expertise in journal manuscript development, regulatory submissions, and clinical study documentation within the biopharmaceutical, medical device, or CRO industry.
This role requires advanced scientific writing capability, regulatory knowledge, cross-functional leadership, and publication compliance expertise aligned with global standards.
Key Responsibilities
Lead the development and timely delivery of publication and regulatory medical writing projects.
Author, review, and finalize:
Journal manuscripts
Abstracts, posters, and scientific presentations
Clinical Study Protocols and Amendments
Clinical Study Reports (CSRs)
Investigator Brochures
Patient Narratives
Plain Language Summaries
Periodic Safety Update Reports (PSURs)
Clinical Development Plans
IND, NDA, and eCTD submissions
Integrated Summary Reports
Informed Consent Forms
Ensure strict compliance with ICH E3 guidelines, FDA regulations, global regulatory requirements, and Good Publication Practices (GPP).
Coordinate quality control and editorial review processes.
Lead resolution of client comments and manage document review cycles.
Review statistical analysis plans (SAPs) and table/figure/listing (TFL) outputs for scientific accuracy, clarity, and consistency.
Conduct systematic literature searches and ensure copyright compliance.
Mentor and guide junior medical writers on complex regulatory and publication projects.
Provide technical consultation and contribute to process improvements and internal capability development.
Manage assigned project budgets, timelines, and deliverables.
Collaborate cross-functionally with Biostatistics, Data Management, Regulatory Affairs, and Medical Affairs teams.
Support regulatory agency interactions through preparation of briefing documents and response packages.
Travel requirement: Less than 25%.
Required Qualifications
3–5 years of relevant experience in medical, scientific, or technical writing.
Prior experience in a biopharmaceutical company, medical device organization, or Contract Research Organization (CRO) is mandatory.
Demonstrated expertise in publication writing and regulatory documentation.
Strong understanding of FDA regulations, ICH guidelines (including ICH E3), and global regulatory frameworks.
Knowledge of Good Publication Practices (GPP).
Strong familiarity with the AMA Manual of Style.
Advanced ability to interpret and analyze statistical outputs.
Excellent command of English grammar and scientific communication.
Proven leadership, mentoring, and stakeholder management skills.
Proficiency in Microsoft Word, Excel, PowerPoint, and literature research databases.
Role Impact and Contribution
The Senior Medical Writer serves as a subject matter expert in publication and regulatory writing, contributing directly to the successful submission, dissemination, and communication of clinical research data. This role may independently manage full-scale projects and guide junior professionals while ensuring regulatory compliance, scientific integrity, and timely delivery.
About the Organization
This global biopharmaceutical solutions provider operates across more than 110 countries with a workforce of approximately 29,000 professionals. Over the past five years, the organization has supported:
94% of Novel FDA-approved drugs
95% of EMA-authorized products
200+ clinical studies
73,000 research sites
675,000+ clinical trial patients
The organization emphasizes career progression, structured training, therapeutic expertise development, and a collaborative global culture focused on accelerating therapy development and commercialization.
Equal Opportunity Statement
The employer is committed to building a diverse, inclusive, and equitable workplace. Candidates with transferable skills and relevant experience are encouraged to apply. Reasonable accommodations are provided in accordance with applicable employment laws and regulations.
Discover verified global opportunities in medical writing, clinical research, pharmacovigilance, regulatory affairs, and pharmaceutical sciences at ThePharmaDaily.com – your trusted global pharma job portal.
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