Associate Manager - Regulatory Solutions

10-12 years

Not Disclosed

Bangalore

10 March 10, 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 - Regulatory Solutions
Date: 18 Feb 2025
Location: Bangalore, KA, IN

We are a technology-led healthcare solutions provider driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated global growth opportunities for talent that is bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com.

Education:

MBBS/PhD/MDS/BDS/MPharm/PharmD

Experience:

10 to 12 years of 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, providing review support for medical writing deliverables that support the clinical regulatory writing portfolio, and training junior writers.

Skills:

Experience in authoring a broad set of clinical document types supporting regulatory filings, including Module 2.4, 2.5, 2.6, 2.7, 5.2, CSRs, protocols, amendments, ICFs, and IBs.
Demonstrated excellence in focused/lean writing and editing following defined processes and templates.
Lead cross-functional teams to draft scientific/medical content addressing data interpretation, product claims, and internal/external questions.
Understanding of the clinical development process from program planning to submission, including clinical trial design.
Effective communication, time management, organizational, and interpersonal skills.
Minimum of 2 years of people management experience.
Customer-focused with the ability to work independently while maintaining communication with the Sponsor’s MW project manager.
Ability to manage tasks, roles, responsibilities, and timelines for document development and delivery.
Adherence to defined processes and Sponsor best practices.
Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements.

Knowledge Requirements:

Scientific Knowledge:

Strong knowledge of regulatory guidelines/requirements (EU, US, and other regional regulations).
Ability to interpret data and apply scientific knowledge to regulatory document writing (IB, protocols, amendments, CSR, Clinical summaries).
Ability to construct clinical or regulatory arguments using logic, analogy, and therapeutic area science.
Understanding of medical practices regarding disease states, procedures, and treatments.
Experience writing protocols, amendments, CSR, and CTD summary documents.

Technology Skills:

Expertise in MS Word, including working with Word add-ins and document management systems.
Experience managing workflows, approvals, and eSignatures.
Adaptability to new tools and technologies.
Ability to train writers/authors on templates, guidelines, and tools.

Responsibilities:

Prepare/review clinical study reports, protocols, investigator brochures, submission documents (Module 2 summaries), and other regulatory documents on investigational drugs in various clinical development stages.
Apply lean authoring principles and structured content management text libraries.
Coordinate and initiate activities for document review, consensus meetings, quality control, and document finalization within tight timelines.
Develop and maintain project plans and work plans for team members.
Lead and manage a team of medical writers.
Represent Medical Writing in cross-functional teams.
Conduct document kick-off meetings with writers and cross-functional representatives.
Ensure standard content adherence, lean authoring, and consistency in messaging across teams.
Maintain open communication among team members and disseminate relevant information appropriately.
Coach and mentor junior team members.
Conduct literature searches and screening, as required.
Participate in Medical Writing department initiatives.
Research regulatory requirements to stay updated on evolving guidelines.
Share best practices and lessons learned.
Ensure compliance with company training and time reporting.

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Associate Manager - Regulatory Solutions

Job Description

Education:

Experience:

Role Purpose:

Skills:

Knowledge Requirements:

Responsibilities:

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