Lead - Regulatory Solutions

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

Lead - Regulatory Solutions
Date: 21 Mar 2025
Location: Bangalore, KA, IN

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s 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’ 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 a broad set of different clinical document types that support regulatory filings, with a preference for experience with Module 2.4, 2.5, 2.6, 2.7, 5.2, clinical study reports (CSRs), protocols, amendments, ICFs & amendments, and Investigator Brochures (IBs).
Demonstrated excellence in focused/lean writing and editing following defined processes and templates.
Lead cross-functional teams to draft agreed-upon scientific/medical content that addresses data interpretation, product claims, and internal/external questions.
Understanding of clinical development processes from program planning to submission, including clinical trial design.
Effective time management, organizational, and interpersonal skills.
People management experience for more than 2 years.
Customer focus and ability to follow directions, templates, and structured processes for delivering documents for review and finalization.
Ability to manage tasks, roles, responsibilities, and timelines of the authoring team, internal/external contributors, and reviewers.
Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements.

KNOWLEDGE REQUIREMENTS:
Scientific Knowledge:

Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States.
Ability to interpret data and apply scientific knowledge to support regulatory document writing (e.g., IB, protocols, amendments, CSR, Clinical summaries).
Understanding of medical practices regarding procedures, medications, and treatment for different disease states.
Ability to provide insights, alternatives, and suggestions based on previous experiences.
Experience writing protocols, amendments, CSR, and CTD summary documents.

Technology Skills:

Expert authoring in MS Word with a strong understanding of MS Word functionality.
Experience working in document management systems, managing workflows, and eApproval/signatures.
Experience with Word add-ins that facilitate the management of fonts, styles, and references.
Flexibility in adapting to new tools and technology.
Capable of training writers/authors on the use of 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 stages of clinical development without guidance from senior members.
Apply lean authoring principles as part of document development and, when applicable, structured content management text libraries.
Coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines.
Develop and maintain project plans and work plans for team members.
People management and coaching of junior team members.
Work as an active member of 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 across team members.
Conduct appropriate literature searches and screening, as needed.
Participate in Medical Writing department initiatives, as appropriate.
Research regulatory requirements to remain current in the regulatory landscape.
Share lessons learned and best practices.
Ensure compliance with company training and time reporting.

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