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Associate Manager – Scientific Writing

10-12 years
Not Disclosed
10 Nov. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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