Associate Manager - Scientific Writing

Indegene

10-12 years

Not Disclosed

Bangalore

10 March 25, 2025

Job Description

Job Type: Full Time Education: MBBS/PhD/MDS/BDS/MPharm/PharmD 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
Date: 8 Mar 2025
Location: Bangalore, KA, IN

Education:

MBBS/PhD/MDS/BDS/MPharm/PharmD

Experience:

10 to 12 years’ experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5)

Role Purpose:

This role is responsible for handling complex Medical Writing projects and providing review support for medical writing deliverables that support the clinical regulatory writing portfolio along with training junior writers.

Skills:

Experience in authoring clinical document types supporting regulatory filings, including Module 2.4, 2.5, 2.6, 2.7, 5.2, clinical study reports (CSRs), protocols, amendments, ICFs, and Investigator Brochures (IBs).
Demonstrated excellence in lean writing and editing following defined processes and templates.
Ability to lead cross-functional teams to draft medical/scientific content addressing data interpretation, product claims, and internal/external questions.
Understanding of clinical development processes from program planning to submission, including clinical trial design.
Strong communication skills aligned with a professional working environment.
Effective time management, organizational, and interpersonal skills.
Minimum 2 years of people management experience.
Customer-focused mindset.
Ability to work independently while maintaining communication with the Sponsor’s MW project manager.
Flexibility to move across Therapeutic Areas to support business needs.
Proficiency in developing, coordinating, and overseeing work plans for individual and multi-document delivery.
Ability to manage tasks, roles, and responsibilities efficiently, ensuring milestone completion within specified timelines.
Adherence to processes and Sponsor-defined best practices.
Ability to facilitate review meetings, address feedback, and negotiate solutions.

Knowledge Requirements:

Scientific Knowledge:

Strong knowledge of global and regional regulatory guidelines (EU, US, etc.).
Ability to interpret data and apply scientific knowledge to support regulatory document writing.
Capability to build clinical or regulatory arguments using logic, analogy, and therapeutic area expertise.
Understanding of medical practices for various disease states.
Ability to maintain message consistency with historical information and align with agreed strategy.
Proficiency in providing insight, alternatives, and suggestions based on prior experience.

Technology Skills:

Expert in MS Word with strong knowledge of its functionalities.
Experience with document management systems and managing workflows.
Proficiency in using Word add-ins to manage fonts, styles, and references.
Adaptability to new tools and technologies.
Ability to train authors/writers on templates, guidelines, and tools.

Responsibilities:

Independently prepare/review clinical study reports, protocols, investigator brochures, and submission documents (Module 2 summaries).
Apply lean authoring principles and structured content management text libraries.
Coordinate activities for document review, consensus meetings, quality control, and document finalization under aggressive timelines.
Develop and maintain project plans and work plans for team members.
Provide people management and mentorship to junior team members.
Actively participate in cross-functional teams representing Medical Writing.
Coordinate and deliver document kick-off meetings with writers and cross-functional representatives.
Ensure adherence to standard content, lean authoring, and messaging consistency.
Facilitate open communication and ensure appropriate information dissemination.
Conduct literature searches and screenings as needed.
Participate in Medical Writing department initiatives.
Stay updated on regulatory requirements and share best practices.
Ensure compliance with company training and time reporting.

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Associate Manager - Scientific Writing

Job Description

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