Medical Writer
Company: Excelya
Location: Bengaluru, Karnataka, India
Department: Medical Affairs
Job Type: Full-Time
Work Mode: Hybrid
Experience: 0–1 Year
JOB OVERVIEW
The Medical Writer is responsible for preparing high-quality regulatory and medical writing documents to support clinical research and regulatory submissions. The role involves drafting clinical study documents, regulatory submissions, investigator brochures, informed consent forms, patient-facing materials, and medical communications while ensuring scientific accuracy, regulatory compliance, and adherence to ICH guidelines and company SOPs. The Medical Writer also supports document redaction activities in accordance with transparency regulations and collaborates with cross-functional teams to deliver high-quality medical writing projects.
KEY RESPONSIBILITIES
Medical Writing
Draft and edit regulatory and medical writing documents.
Prepare clinical study protocols and protocol synopses.
Develop Investigator Brochures (IBs).
Write IND submission documents and supporting materials.
Prepare clinical narratives and medical reports.
Clinical & Regulatory Documentation
Draft informed consent forms (ICFs).
Prepare patient information sheets and questionnaires.
Develop Case Report Forms (CRFs) and observation booklets.
Support authorization request documentation for regulatory authorities.
Ensure document readiness for regulatory submissions.
Document Redaction
Perform redaction of clinical and regulatory documents.
Identify personally identifiable information (PII) and commercially confidential information.
Apply approved redaction strategies.
Ensure compliance with transparency regulations.
Maintain consistency across disclosure packages.
Quality & Compliance
Ensure scientific accuracy and consistency of all documents.
Verify references, tables, figures, and supporting data.
Review Statistical Analysis Plans (SAPs).
Review Tables, Figures, and Listings (TFLs).
Ensure compliance with sponsor SOPs, company procedures, and global regulations.
Cross-Functional Collaboration
Collaborate with Medical Advisors and Medical Monitors.
Work closely with Biostatistics, Statistical Programming, and Data Management teams.
Coordinate with Project Managers for timely document delivery.
Support multidisciplinary project teams.
Participate in review meetings and document discussions.
Regulatory Knowledge
Maintain knowledge of ICH guidelines.
Follow CONSORT, STROBE, and PRISMA reporting guidelines.
Stay updated on international regulatory requirements.
Support regulatory writing activities.
Ensure compliance with applicable legislation.
Documentation Review
Review medical writing deliverables for grammar, formatting, and consistency.
Verify accuracy of scientific content.
Review statistical outputs for reporting quality.
Maintain high-quality writing standards.
Support document finalization and publication readiness.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in Life Sciences
Pharmacy
Biotechnology
Biochemistry
Biomedical Sciences
Medicine
Or an equivalent scientific discipline
Preferred
Postgraduate degree in a related scientific field
EXPERIENCE REQUIREMENTS
Required
Freshers and candidates with up to 1 year of Medical Writing experience can apply.
Preferred
Experience in Medical Writing
Regulatory Writing exposure
Clinical Research knowledge
Medical Affairs experience
Uttar Pradesh :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Birmingham |Virginia :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
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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 :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
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Lake Charles | Shreveport |Nevada :
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Lisbon | Oeiras | Portugal |WI :
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Mexico |northeastern :
New Hampshire |Oklahoma :
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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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Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
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 :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
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Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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 | North York | Renfrew | Richmond Hill | Australia | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |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 :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Be'Er Sheva | Tel Aviv | Kfar Saba | Netanya | Yavne |Remote :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
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Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Singapore |Sofia City :
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Sweden |Taipei :
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Warsaw |
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