Associate Manager – Scientific Writing (Fresher Eligible)
Location: Karnataka, India
Category: Clinical Research | Regulatory Writing | Medical Affairs
About the Role
The Associate Manager – Scientific Writing supports global clinical and regulatory documentation for international submissions, including CTD Module 2 and Module 5 deliverables. This role involves handling complex medical writing projects, providing content review support, managing cross-functional interactions and guiding junior scientific writers.
Although traditionally a senior-level position, freshers with strong academic credentials, scientific writing aptitude and advanced degrees are eligible to apply, as per the requirement.
Experience Level
Experience Required: Fresher eligible (0 years).
Candidates with academic research exposure, internships or strong scientific writing skills will be considered an added advantage.
Educational Qualifications
Candidates must hold one of the following degrees:
MBBS, PhD, MDS, BDS, MPharm or PharmD
Key Responsibilities
Medical & Regulatory Writing
Independently prepare and review complex regulatory documents including Clinical Study Reports (CSRs), protocols, amendments, Investigator Brochures (IBs), and CTD Module 2 summaries
Apply lean authoring principles and structured content management to ensure consistency and clarity
Coordinate document review cycles, quality control checks and finalization activities within defined timelines
Conduct literature searches and scientific screenings to support content development
Project & Team Leadership
Develop, manage and monitor detailed work plans for multiple documents and teams
Facilitate kick-off meetings, stakeholder discussions and consensus-building sessions
Ensure seamless cross-functional communication across Medical Writing, Clinical, Regulatory and other partner teams
Support onboarding, orientation and mentoring of junior writers
Strategic & Process Excellence
Ensure adherence to sponsor-defined templates, processes and best practices
Maintain alignment with historical messaging and regulatory strategy
Participate in departmental initiatives and implement continuous improvement opportunities
Stay current with evolving global regulatory requirements through research and learning
Required Skills
Scientific & Regulatory Knowledge
Understanding of CTD requirements and global regulatory guidelines (US, EU and relevant regions)
Ability to interpret clinical data and develop scientific arguments logically and accurately
Knowledge of clinical development processes, clinical trial methodology and disease-area fundamentals
Technical Skills
Expert proficiency in Microsoft Word, including templates, styles, formatting and reference tools
Experience with document management systems and workflow tools
Ability to learn and adapt quickly to new scientific writing technologies and platforms
Professional Competencies
Strong communication skills suited for global stakeholders
Effective time management and organizational capabilities
Ability to work independently while maintaining proactive communication
Customer-focused, detail-oriented and capable of supporting multiple therapeutic areas
Additional Capabilities
Capacity to manage document timelines, task distribution and internal/external reviewer inputs
Ability to facilitate review meetings and drive consensus among cross-functional teams
Commitment to quality, compliance and accurate documentation
Strong analytical skills and capability to propose scientifically sound solutions
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Saarbrucken |Switzerland :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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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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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
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Argentina | Peru |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 :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
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