Medical Writing Lead
Company: Alvotech
Location: Bangalore Office / India Home Office (Partially Remote)
Job Type: Full-Time
Experience: 7+ Years (with 3+ Years in Leadership)
Qualification: MSc / PhD in Life Sciences, PharmD, MD or related scientific discipline
Approx Salary: ₹25 LPA – ₹40 LPA
Job Overview
Alvotech is seeking an experienced Medical Writing Lead to oversee scientific and regulatory documentation across the entire product lifecycle—from clinical development to regulatory submission and post-marketing activities. The role requires strong expertise in clinical documentation, safety reporting, and scientific communication, along with leadership responsibilities to manage and mentor a team of medical writers.
Key Responsibilities
1. Clinical Development Documentation
Lead preparation of key clinical documents including clinical trial protocols, protocol amendments, investigator brochures, and clinical study reports (CSRs).
Ensure documentation aligns with clinical safety strategies and regulatory guidelines.
Translate complex scientific and clinical data into clear, accurate, and compliant regulatory documents.
2. Regulatory & Safety Documentation
Support preparation of regulatory submission documents and development safety reports.
Ensure compliance with global regulatory requirements and pharmacovigilance standards.
Maintain document accuracy and consistency throughout the product lifecycle.
3. Post-Marketing Scientific Communication
Oversee development of scientific publications and post-marketing safety documentation.
Support pharmacovigilance-related medical writing activities.
Ensure high-quality dissemination of clinical data to regulatory authorities and healthcare professionals.
4. Cross-Functional Collaboration
Collaborate closely with Clinical Development, Biostatistics, Pharmacovigilance, and Regulatory Affairs teams.
Participate in data interpretation, analysis, and presentation for clinical study results.
Coordinate with internal stakeholders to ensure timely document delivery.
5. Leadership & Team Management
Manage and mentor a team of medical writers.
Coordinate writing activities and maintain high quality across documents.
Provide guidance on scientific storytelling and regulatory writing standards.
6. Document Management & Quality
Oversee document lifecycle management and ensure timely submission and regulatory compliance.
Utilize document management systems for version control and document tracking.
Ensure adherence to ICH guidelines, GCP standards, and global regulatory requirements.
Required Skills
Technical Skills
Expertise in clinical and regulatory medical writing
Experience with clinical protocols, CSRs, investigator brochures, safety reports, and submission documents
Strong knowledge of Good Clinical Practice (GCP) and ICH guidelines
Understanding of pharmacovigilance regulations and clinical trial documentation
Experience with document management systems
Soft Skills
Excellent scientific communication and storytelling abilities
Strong analytical and data interpretation skills
Leadership and team management capability
Effective stakeholder collaboration in multicultural teams
High attention to detail and regulatory compliance
Preferred Skills
Experience working on biosimilar clinical trials
Expertise in global regulatory submission processes
Exposure to cross-functional pharmaceutical R&D environments
Role Impact
The Medical Writing Lead plays a critical role in ensuring accurate scientific communication and regulatory compliance throughout the product lifecycle. By leading medical writing activities and guiding the writing team, the role supports successful clinical development, regulatory approvals, and post-marketing safety documentation for biosimilar medicines.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
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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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 :
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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Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
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Boulder | Denver | Westminster |Connecticut :
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Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
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 :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lisbon | Oeiras | Portugal |WI :
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Oklahoma City |Puerto Rico :
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Tuscaloosa |D.C :
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Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
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 :
Beijing |China :
China | Quarry Bay |Liaoning :
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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 :
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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 :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
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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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 :
Bangkok |Israel :
Kfar Saba | Be'Er Sheva | Tel Aviv | Netanya | Yavne |Remote :
Switzerland | Faridabad | Thailand | Minnesota | Lousiana | Remote | Lenexa | Remote - Africa | Springville | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Middle East | Victoria | Manipal | Nairobi | Ireland | Remote - South America (Latin Americal) | French | Texas | Tulsa | Bishop | Green Way | Xzagreb | McFarland | Bountiful | Hungary | Leinster | Zaragoza | Blue Bell | Riga | Castlebar | Belgium | Slovakia | Hammond | Medan | Remote - Europe | Melbourne | Remote, USA |Republic of Colombia :
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Ciudad de México | New Mexico |Dubai :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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