Senior Medical Writer II
Location: India
Employment Type: Full-Time
Experience Required: Minimum 6–10 Years
Job Requisition ID: JR 7810
Industry: Pharmaceutical | Biotechnology | Medical Devices | Clinical Research
About ProPharma
For more than two decades, ProPharma has supported global biotech, medical device, and pharmaceutical organizations in advancing scientific innovation and delivering new therapies to patients. Operating through an advise–build–operate model, ProPharma provides comprehensive consulting solutions across the entire product lifecycle. With deep expertise in regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients to de-risk development programs and accelerate successful market entry.
Role Overview
The Senior Medical Writer II is a highly experienced contributor responsible for authoring, reviewing, and managing complex medical writing deliverables across multiple therapeutic areas and stages of clinical development. This role requires advanced regulatory knowledge, strong project leadership capabilities, and the ability to collaborate directly with clients and cross-functional teams while ensuring accuracy, compliance, and on-time delivery of high-quality documents.
Key Responsibilities
Author and edit high-quality clinical, regulatory, safety, medical device, diagnostics, and disclosure documents across all phases of clinical research with minimal supervision
Develop complex submission-level documents, including INDs, NDAs, BLAs, MAAs, eCTD modules, PBRERs, DSURs, CEPs/CERs, and plain language summaries
Ensure full compliance with applicable regulatory standards and guidelines, including ICH E3, ICH E6 (R2), EU MDR/IVDR, company SOPs, client standards, and approved templates
Lead and manage document timelines, budgets, and deliverables while proactively managing client expectations
Supervise, mentor, and provide technical guidance to junior and mid-level medical writers as required
Collaborate with subject matter experts in clinical operations, biostatistics, data management, regulatory affairs, and pharmacovigilance
Coordinate and perform quality control reviews, maintain audit trails, and support inspection readiness
Review statistical analysis plans and tables, figures, and listings for accuracy, consistency, and regulatory alignment
Conduct peer reviews of documents authored by other medical writers
Manage multiple projects simultaneously while maintaining high standards of quality and efficiency
Support internal process improvement initiatives, departmental training, and knowledge-sharing activities
Required Skills and Competencies
Advanced understanding of clinical research methodology and regulatory submission processes
Strong knowledge of global regulatory requirements, including FDA, EMA, and other health authorities
Proven ability to interpret, analyze, and clearly present complex clinical and safety data
Expert-level proficiency in Microsoft Word, including advanced document formatting, tables, graphs, and figures
Excellent project management, organizational, and stakeholder communication skills
High attention to detail, strong quality mindset, and ability to work independently
Proficiency in written and spoken English with familiarity in AMA style guidelines
Strong interpersonal skills with demonstrated experience in client-facing roles
Education and Experience Requirements
Bachelor’s degree or higher in a medical, scientific, or life sciences discipline
Minimum of 6 years of professional experience in clinical and/or regulatory medical writing for pharmaceuticals, biologics, medical devices, or diagnostics
Experience within a CRO, pharmaceutical company, biotechnology firm, or medical device organization preferred
Additional relevant education or professional experience may be considered on a case-by-case basis
Work Model
ProPharma supports flexible and remote working arrangements. Candidates located within reasonable commuting distance of a ProPharma office may be encouraged to work in a hybrid model, subject to agreement with the hiring manager.
Diversity, Equity, and Inclusion
ProPharma is an equal opportunity employer committed to fostering a diverse, inclusive, and empowering work environment. Employees are encouraged to bring their authentic selves to work and contribute to a culture of collaboration, innovation, and continuous growth.
Recruitment Notice
All applications are personally reviewed by ProPharma’s recruitment team. ProPharma does not accept unsolicited resumes from third-party recruiters for this role.
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Hajipur | Patna |Kerala :
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Siliguri |Illinois :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
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