Medical Writer – Clinical & Medical Affairs
Company: Alvotech
Location: Bangalore, India (Partially Remote)
Job Type: Full-Time | Remote
Experience: Typically 5+ Years (Medical Writing / Clinical Development / Pharmacovigilance)
Qualification: MSc / PhD / PharmD / MD or related Life Sciences discipline
Salary Range: Not Specified
Job Overview
Alvotech is seeking a Medical Writer to support scientific and regulatory documentation across the full product lifecycle.
The Medical Writer will be responsible for translating complex clinical, scientific, and safety data into clear, accurate, and compliant documents for regulatory authorities, healthcare professionals, and internal stakeholders. The role has a strong focus on pharmacovigilance-related writing activities.
This position plays a key role in supporting clinical development, regulatory submissions, and post-marketing activities while ensuring alignment with global regulatory standards.
Key Responsibilities
Medical Writing & Documentation
Lead preparation of clinical and regulatory documents across the product lifecycle.
Develop clinical trial protocols, protocol amendments, and clinical study reports (CSRs).
Prepare development safety sections aligned with clinical safety strategy.
Ensure clarity, accuracy, and regulatory compliance in all documents.
Pharmacovigilance Writing
Lead pharmacovigilance-related writing activities.
Prepare safety documents and reports for post-marketing activities.
Support development of safety narratives and aggregate safety documents.
Ensure alignment with global pharmacovigilance standards.
Clinical Development Support
Support documentation during clinical development phases.
Contribute to Investigator Brochures (IBs) and submission documents.
Collaborate on clinical study documentation and reporting.
Ensure consistency across clinical and regulatory documents.
Scientific Publications
Guide development of scientific publications and manuscripts.
Support preparation of abstracts, posters, and journal articles.
Ensure scientific accuracy and clarity in communication.
Data Interpretation & Presentation
Collaborate with cross-functional teams for data interpretation.
Translate complex clinical and statistical data into meaningful insights.
Present data in a clear and structured format for different stakeholders.
Document Management & Compliance
Manage timelines and delivery of writing projects.
Ensure documents meet GCP, PV, and ICH regulatory standards.
Utilize document management systems for version control and compliance.
Cross-Functional Collaboration
Work closely with Clinical Development, Biostatistics, and Pharmacovigilance teams.
Collaborate with global and multicultural teams.
Support alignment across departments for consistent messaging.
Required Skills
Medical Writing Expertise
Strong experience in medical and regulatory writing.
Ability to write across multiple document types (protocols, CSRs, IBs, safety reports).
Excellent scientific storytelling and data interpretation skills.
Pharmacovigilance Knowledge
Experience in pharmacovigilance-related writing.
Understanding of safety reporting and post-marketing documentation.
Knowledge of global PV regulations and safety standards.
Regulatory & Compliance Knowledge
Strong knowledge of GCP and ICH guidelines.
Understanding of global regulatory submission requirements.
Experience ensuring compliance in clinical documentation.
Communication & Collaboration
Excellent written and verbal communication skills.
Ability to work in cross-functional and multicultural teams.
Strong attention to detail and organizational skills.
Preferred Qualifications
Experience in biosimilar clinical development programs.
Experience working in CRO or pharmaceutical environments.
Familiarity with document management systems.
Key Competencies
Medical and regulatory writing across product lifecycle
Pharmacovigilance and safety documentation
Clinical trial documentation and reporting
Scientific data interpretation and communication
Regulatory compliance (GCP, PV, ICH)
Cross-functional collaboration and teamwork
About the Company
Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on the development and manufacturing of high-quality biosimilar medicines.
Within its Integrated Clinical and Medical Research (iCMR) function, the organization supports clinical strategies aligned with global regulatory requirements and biosimilar guidelines, enabling successful clinical trials and post-marketing activities worldwide.
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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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 :
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Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | Uxbridge | Australia | Richmond Hill | Renfrew | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
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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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Austria |Vienna :
Vienna |Catalonia :
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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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 :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Sweden |Taipei :
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