Senior Associate - Scientific Writing

Indegene

4+ years

Not Disclosed

Bangalore

10 Dec. 4, 2024

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

Position Title: Lead Medical Writer
Department: Medical Writing
Location: Bangalore, KA, IN

Job Purpose

The Lead Medical Writer is responsible for the development, review, and submission of medical writing deliverables supporting global regulatory filings, particularly CTD Module 2 and Module 5. The role also includes training and mentoring junior writers and ensuring timely delivery of high-quality clinical and regulatory documents.

Key Responsibilities

Lead the authoring and review of various clinical documents for regulatory filings, including Module 2.3, 2.4, 2.5, 2.7, 5.2, clinical study reports (CSRs), protocols, informed consent forms, amendments, and investigator brochures (IBs).
Ensure adherence to defined writing processes and templates for focused/lean writing and editing.
Lead cross-functional teams to draft scientific and medical content, addressing data interpretation, product claims, and internal/external inquiries.
Oversee document development from clinical trial design to regulatory submission, ensuring alignment with regulatory guidelines and therapeutic area science.
Manage and coordinate document delivery timelines, ensuring efficient and effective progress through milestone tasks and reviews.
Develop and maintain detailed work plans for individual or multiple document deliveries.
Conduct review meetings, address feedback, and negotiate solutions with contributors and reviewers.
Provide guidance and training to junior writers on writing processes, templates, and tools.
Maintain open communication with cross-functional teams, ensuring all team members are informed and documents meet quality standards.
Stay updated on regulatory guidelines, including those from the EU, US, and other regional bodies, ensuring documents comply with current regulatory standards.
Facilitate literature searches, as necessary, and actively participate in departmental initiatives and continuous process improvements.

Skills & Qualifications

Education: MBBS/PhD/MDS/BDS/MPharm/PharmD
Experience: 4-6 years in writing clinical and regulatory documents for global filings, with a strong focus on CTD Modules 2 and 5.
Technical Skills:
- Expert authoring in MS Word, with a solid understanding of functionality and document management systems.
- Experience with Word add-ins and tools for managing fonts, styles, references, etc.
- Flexibility in adapting to new tools and technology.
Knowledge:
- Strong understanding of regulatory guidelines and scientific knowledge to support regulatory document writing.
- Ability to build clinical or regulatory arguments in the absence of direct data.
- Expertise in clinical and regulatory documents like protocols, amendments, CSR, and CTD summaries.
Communication & Organizational Skills:
- Excellent written and verbal communication skills.
- Ability to manage cross-functional communication and ensure alignment with strategy and messaging.
- Strong organizational and time management skills, with the ability to work independently while managing multiple tasks and deadlines.
Leadership: Experience leading cross-functional teams and coaching junior team members.

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Senior Associate - Scientific Writing

Job Description

Job Purpose

Key Responsibilities

Skills & Qualifications

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