Senior Medical Writer – Clinical Research (Fully Remote, India)
Job ID: R-01332283
Job Type: Full Time
Category: Clinical Research / Medical Writing
Work Mode: Fully Remote
Location: India
Work Schedule: Monday to Friday (Standard Business Hours)
About the Role
We are seeking an experienced Senior Medical Writer to support global clinical research programs within a leading Contract Research Organization (CRO). This role is critical to the planning, development, review, and delivery of high-quality medical and scientific documents that support clinical development, regulatory submissions, and client communications.
As a Senior Medical Writer, you will serve as a primary author for key clinical documents, collaborate with cross-functional stakeholders, ensure regulatory compliance, and contribute to process excellence across projects. You may also support program management activities and mentor junior writers.
Key Responsibilities
Lead the end-to-end development of medical and scientific documents from planning through final delivery for internal and external clients.
Serve as primary author for routine clinical documents, including Clinical Study Reports (CSRs), study protocols, and related summaries.
Research, write, and edit complex clinical and regulatory documents such as Investigator’s Brochures (IBs), INDs, MAAs, and other program-level deliverables.
Interpret and summarize clinical data accurately and clearly for scientific and regulatory audiences.
Review documents prepared by junior medical writers to ensure quality, consistency, and compliance.
Provide guidance, training, and mentorship to junior writers and support program managers on document development processes and regulatory requirements.
Ensure all assigned documents comply with global, regional, and country-specific regulatory guidelines and internal quality standards.
Contribute to the development and continuous improvement of best practices, templates, and client-specific writing processes.
Support program management activities, including identifying and resolving out-of-scope work, assisting with timelines, budgets, forecasts, and contract modifications.
Represent the medical writing function in project launch meetings, team reviews, and cross-functional discussions.
Education and Experience Requirements
Bachelor’s degree in a scientific discipline (Life Sciences, Pharmacy, Medicine, or related field); an advanced degree is preferred.
Minimum 5+ years of experience in medical writing within the pharmaceutical, biotechnology, or CRO industry.
Demonstrated experience authoring clinical and regulatory documents across multiple study phases.
Prior experience working in a global CRO or regulated clinical research environment is strongly preferred.
Professional certifications in medical writing or regulatory affairs (AMWA, EMWA, RAC) are advantageous.
Equivalent combinations of education, training, and relevant experience may be considered.
Required Knowledge, Skills, and Competencies
Strong medical and scientific writing skills, including data interpretation, editing, and proofreading.
Excellent understanding of global document development standards and regulatory guidelines.
In-depth knowledge in one or more specialty areas such as clinical development, regulatory submissions, therapeutic areas, or scientific communications.
Strong project management and organizational skills with the ability to manage multiple deliverables.
Excellent written and verbal communication skills, including presentation and stakeholder engagement.
Sound judgment, decision-making, and problem-solving abilities.
Proficiency in document authoring tools, client templates, and document management systems.
Strong computer skills, including Microsoft Word, Excel, Outlook, and related applications.
Ability to work independently in a remote environment while collaborating effectively with global teams.
Why Join Us
Work on global clinical development programs that contribute to bringing innovative therapies to market.
Gain exposure to complex regulatory and scientific writing projects across multiple therapeutic areas.
Collaborate with experienced clinical research professionals in a quality-driven, compliant environment.
Benefit from continuous learning, mentorship, and long-term career growth opportunities in medical writing and clinical research.
Enjoy the flexibility of a fully remote role while contributing to high-impact global studies.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
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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Mexico |northeastern :
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Washington |Delaware :
Wilmington |North Rhine Westphalia :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
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Belgrade | Serbia |Hungary :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
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 :
Mississauga | Richmond Hill | Uxbridge | Renfrew | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
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Be'Er Sheva | Tel Aviv | Netanya | Yavne | Kfar Saba |Remote :
Victoria | Manipal | Minnesota | Melbourne | Remote - Europe | Xzagreb | Switzerland | French | Green Way | Ireland | Remote, USA | Tulsa | Lenexa | Remote | Remote - Middle East | Zaragoza | Regulatory Labeling Manager (NA and LATAM Only) | Riga | Nairobi | Texas | Belgium | Castlebar | Hammond | Lousiana | McFarland | Slovakia | Remote - Africa | Hungary | Leinster | Bountiful | Bishop | Blue Bell | Thailand | Springville | Medan | Remote - South America (Latin Americal) | Faridabad |Republic of Colombia :
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Brentwood |Bucharest :
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Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
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Khulais | Najran | Jeddah | Rabigh | King Abdullah Economic City | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |