Associate Manager - Scientific Writing

Indegene

10-12 years

Not Disclosed

Bangalore

10 Sept. 16, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Job Title: Associate Manager - Scientific Writing

Date Posted: 23 Aug 2025
Location: Bangalore, KA, India

Education:

MBBS / PhD / MDS / BDS / MPharm / PharmD

Experience:

10–12 years in clinical and regulatory document writing supporting global filings (CTD Module 2 and Module 5)

Role Purpose:

Responsible for managing complex medical writing projects, providing review support for clinical regulatory writing deliverables, and training junior writers.

Key Skills:

Medical & Scientific Expertise:

Author a wide range of clinical documents supporting regulatory filings (Modules 2.4, 2.5, 2.6, 2.7, 5.2), clinical study reports (CSRs), protocols, amendments, ICFs, Investigator Brochures (IBs).
Focused/lean writing and editing following defined processes and templates.
Lead cross-functional teams to draft scientific content addressing data interpretation, product claims, and internal/external questions.
Understanding of clinical development from program planning to submission, including trial design.
Ability to work independently while coordinating with Sponsor’s MW project manager.
Flexibility to work across therapeutic areas to support business continuity.
Develop and oversee work plans for individual and multiple-document deliveries, including timelines, tasks, and assigned responsibilities.
Facilitate review meetings, address feedback, and negotiate solutions.

People Management:

Minimum 2 years of experience in people management.
Ability to manage authoring teams, internal/external contributors, and reviewers efficiently.

Technology Skills:

Expert in MS Word and advanced functionalities.
Experience with document management systems, workflow approvals, and eSignatures.
Experience with Word add-ins for managing fonts, styles, references.
Ability to train writers/authors on templates, guidelines, and tools.

Communication & Interpersonal Skills:

Strong communication, organizational, and time management skills.
Customer-focused and able to work collaboratively in a professional environment.

Knowledge Requirements:

Scientific Knowledge:

Strong knowledge of global regulatory guidelines (FDA, EMA, ICH) and regional standards.
Ability to interpret data and apply scientific knowledge for regulatory documents (IB, protocols, amendments, CSRs, Clinical Summaries).
Build clinical/regulatory arguments in absence of direct data using logic and therapeutic area knowledge.
Understand medical practices, procedures, medications, and treatment strategies.
Ensure messaging consistency aligned with historical data and agreed strategies.
Provide insights and suggestions based on prior experience.

Responsibilities:

Prepare/review CSRs, protocols, IBs, submission documents (Module 2 summaries), and other regulatory documents independently.
Apply lean authoring principles and structured content management libraries.
Coordinate document review, consensus meetings, quality control, and finalization under tight timelines.
Develop and maintain project plans and team work plans.
Lead and manage team members, including orientation and mentoring of junior writers.
Participate as an active member of cross-functional teams representing Medical Writing.
Coordinate and deliver document kick-off meetings with writers and stakeholders.
Ensure adherence to standard content, lean authoring, and messaging consistency.
Conduct literature searches and screening as needed.
Participate in departmental initiatives and share best practices.
Stay updated on regulatory requirements and research industry trends.
Ensure compliance with company training and time reporting requirements.

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Associate Manager - Scientific Writing

Job Description

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