Senior Medical Writer II
Location: India
Employment Type: Full-Time
Posted On: 30+ Days Ago
Job Requisition ID: JR 7865
About ProPharma
For over 20 years, ProPharma has been dedicated to improving health and wellness worldwide. We partner with biotech, medical device, and pharmaceutical organizations of all sizes through our advise-build-operate model, offering full lifecycle expertise in:
Regulatory Sciences
Clinical Research Solutions
Quality & Compliance
Pharmacovigilance
Medical Information
R&D Technology
Our goal is to de-risk and accelerate high-profile drug and device programs through customizable consulting solutions.
About the Role
ProPharma is seeking an experienced Senior Medical Writer II to join its team in India. This role involves authoring high-quality clinical, regulatory, and safety documents that meet scientific and regulatory standards. The writer will collaborate with cross-functional teams, manage client interactions, and mentor junior writers while contributing to impactful healthcare solutions.
Essential Functions
Author and edit a wide range of medical writing deliverables (clinical, safety, regulatory, device/diagnostics, disclosures).
Examples: Protocols, amendments, study reports, narratives, IBs, ICFs, CEPs/CERs, DSURs, plain language summaries, PBRERs, INDs, NDAs, BLAs, MAAs, eCTD-level documents.
Supervise, train, and mentor less experienced medical writers.
Adhere to global regulatory standards/guidelines (ICH E3/E6(R2), EU MDR/IVDR, SOPs, client templates).
Ensure timely and budget-compliant completion of deliverables.
Lead client interactions, project meetings (kickoffs, comment reviews), and manage deliverable timelines.
Collaborate with SMEs in clinical operations, data management, biostatistics, regulatory affairs, etc.
Coordinate QC reviews of documents and maintain audit trails.
Review statistical analysis plans and TFL shells for accuracy and consistency.
Perform peer review or QC review of documents when required.
Support project administration (timelines, trackers, meeting facilitation).
Stay updated with evolving industry practices, regulatory requirements, and guidelines.
Monitor project budgets and communicate out-of-scope work.
Handle multiple projects simultaneously with minimal supervision.
Escalate issues or risks with proposed solutions to management.
Participate in departmental initiatives (process improvement, trainings, etc.).
Skills & Requirements
Education:
Bachelor’s degree or higher in a medical or scientific discipline (required).
Experience:
Minimum 6 years’ experience in clinical/regulatory medical writing for drugs, biologics, and/or medical devices/diagnostics (CRO, pharma, or biotech setting).
Proven expertise in diverse medical writing deliverables across clinical, safety, and regulatory domains.
Technical Knowledge:
Strong understanding of clinical research principles, therapeutic areas, and phases.
Advanced knowledge of global regulatory guidelines and submission requirements (ICH, FDA, EMA, EU MDR/IVDR).
Proficiency in SOPs, templates, and compliance standards.
Core Skills:
Exceptional project management, communication, and time management.
High attention to detail, quality, and consistency.
Experience mentoring and guiding junior writers.
Ability to collaborate effectively with cross-functional teams and clients.
Proactive, adaptable, and resourceful, with the ability to work independently.
What We Offer
Opportunity to contribute to global medical writing projects of high regulatory and scientific impact.
Collaborative environment with cross-functional exposure.
Growth through mentorship and client-facing responsibilities.
Inclusive workplace culture emphasizing diversity, equity, and innovation.
Gujarat :
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
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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 :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Lisbon | Oeiras | Portugal |WI :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
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Donegal |Meath :
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Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Mississauga | Renfrew | Richmond Hill | Australia |Canada :
Canada |Quebec :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
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Manila |Croatia :
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Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Kfar Saba | Yavne | Be'Er Sheva | Tel Aviv | Netanya |Remote :
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Ciudad de México | New Mexico |Dubai :
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Khulais | Riyadh | Jeddah | Najran | King Abdullah Economic City | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
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