Senior Medical Writer II – India
Category: Medical Writing & Clinical Development | Location: India (Remote/Hybrid) | Job Type: Full-Time
Experience Required: Minimum 6 years in clinical/regulatory writing within pharmaceutical, biotech, or medical device industries
About ProPharma
For over 20 years, ProPharma Group has empowered pharmaceutical, biotech, and medical device organizations to advance scientific breakthroughs and bring innovative therapies to market. Leveraging deep expertise in regulatory sciences, clinical research solutions, medical writing, pharmacovigilance, and R&D technology, ProPharma provides end-to-end consulting solutions across the full product lifecycle, helping clients minimize risk and accelerate high-profile drug and device programs.
Role Overview
ProPharma is seeking an experienced Senior Medical Writer II to join our growing team in India. In this role, you will author, review, and manage high-quality medical writing deliverables across clinical development, regulatory submissions, and therapeutic areas. You will collaborate with cross-functional teams, mentor junior writers, and ensure deliverables meet regulatory standards, client expectations, and internal quality guidelines.
Key Responsibilities:
Author, edit, and manage clinical, safety, regulatory, medical device, and diagnostics documents across all phases of clinical research, including but not limited to:
Clinical protocols, protocol amendments, study reports, patient narratives, Investigator Brochures (IBs), Informed Consent Forms (ICFs)
DSURs, PBRERs, IND/NDA/BLA/MAA submissions, eCTD-level documents, and plain language summaries
Complex regulatory submissions and device/diagnostic documentation (CEPs/CERs)
Lead quality control (QC) reviews, ensure audit-ready documentation, and maintain consistent documentation practices.
Supervise, train, and mentor junior medical writers to enhance team capabilities.
Collaborate with clinical operations, data management, biostatistics, and regulatory teams to produce high-quality, consistent outputs.
Manage client expectations, timelines, and deliverables, participating in meetings such as project kickoffs, review sessions, and comment resolution.
Review statistical analysis plans, tables, figures, and listings for accuracy, format, and consistency.
Maintain familiarity with industry practices, regulatory requirements, and evolving guidelines relevant to medical writing.
Identify inefficiencies or risks in deliverable management and propose solutions to improve quality and timelines.
Required Skills & Competencies
Advanced knowledge of clinical research principles and ability to interpret and present complex clinical data.
Expertise in FDA, EMA, and other regulatory guidelines (ICH E3/E6(R2), EU MDR/IVDR) and submission standards.
Strong project management, organizational, and time management skills.
Exceptional proficiency in MS Word, including formatting tables, graphs, and figures; familiarity with eCTD document creation is a plus.
Superior written and verbal communication skills with proficiency in English; familiarity with AMA style preferred.
Proven ability to collaborate strategically with internal teams and external clients.
Demonstrated ability to work independently, proactively address challenges, and mentor team members.
Educational & Professional Requirements
Bachelor’s degree or higher in Medical, Life Sciences, or related discipline.
Minimum 6 years of professional experience in medical writing for clinical, regulatory, or safety documents within CROs, pharmaceutical, biotechnology, or medical device organizations.
Experience in writing across multiple therapeutic areas and clinical trial phases is preferred.
Why Join ProPharma
Work with a global client base across biotech, pharmaceutical, and medical device sectors.
Participate in high-impact projects supporting regulatory submissions and clinical development globally.
Opportunity to mentor and lead junior writers and contribute to knowledge-sharing initiatives.
Support a flexible remote/hybrid work model while collaborating with cross-functional teams.
Thrive in an inclusive, diverse, and empowering environment that values innovation, integrity, and career growth.
Application Information
ProPharma reviews all applications personally and does not rely on AI screening tools. Candidates will receive feedback regarding their application status. Remote or hybrid candidates within a reasonable distance from office locations are encouraged to consider flexible in-person collaboration.
Deadline: Open until filled
Note: ProPharma Group does not accept unsolicited resumes from recruiters or third parties. Please do not contact employees directly regarding this posting.
SEO/GEO Optimized Keywords:
Senior Medical Writer India, Regulatory Writing Jobs, Clinical Document Writing, Pharmaceutical Medical Writer Careers, CRO Medical Writing India, Clinical Trial Documentation Jobs, eCTD Submission Writer
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