Senior Associate - Scientific Writing

Indegene

4-6 years

Not Disclosed

Bangalore

10 Nov. 26, 2024

Job Description

Job Type: Remote 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 Medical Writer

EDUCATION:

MBBS/PhD/MDS/BDS/MPharm/PharmD

EXPERIENCE:

4 to 6 years of experience in writing clinical and regulatory documents supporting global filings (CTD Module 2 and Module 5).

ROLE PURPOSE:
The Lead Medical Writer is responsible for the development and review of medical writing deliverables supporting the clinical regulatory writing portfolio, including training junior writers.

SKILLS:

Experience in authoring a broad set of clinical document types, especially with Module 2.3, 2.4, 2.5, 2.7, 5.2, clinical study reports (CSRs), protocols, Informed Consent Forms, amendments, and Investigator Brochures (IBs).
Excellent writing and editing skills, with the ability to follow defined processes and templates.
Lead cross-functional teams to draft scientific and medical content that addresses data interpretation, product claims, and internal/external questions.
Understanding of the clinical development process, from program planning to submission, including clinical trial design.
Strong communication, time management, organizational, and interpersonal skills.
Ability to manage tasks, responsibilities, and timing for efficient document delivery.
Ability to adapt and work across therapeutic areas to support resource needs and business continuity.
Expertise in MS Word and familiarity with document management systems and tools.
Ability to train junior writers on templates, guidelines, and tools.

KNOWLEDGE REQUIREMENTS:

Scientific Knowledge:

Strong knowledge of regulatory guidelines/requirements, including those from the European Union and the United States.
Ability to interpret data and apply scientific knowledge in regulatory document writing (IB, protocols, amendments, CSR, clinical summaries).
Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy, and therapeutic area science.
Understanding of medical practices related to disease treatments and procedures.
Experience writing protocols, amendments, CSRs, and CTD summary documents.

Technology Skills:

Expertise in MS Word functionality for authoring.
Experience with document management systems and workflow management for eApproval/signatures.
Flexibility in adapting to new tools and technologies.

RESPONSIBILITIES:

Prepare and review clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents for investigational drugs.
Apply lean authoring principles and structured content management in document development.
Coordinate activities for document review, consensus meetings, quality control, and document finalization.
Develop and maintain project plans.
Act as an active member of cross-functional teams, representing medical writing.
Organize and facilitate document kick-off meetings and ensure team alignment on standard content.
Participate in the orientation and coaching of junior team members.
Conduct literature searches and ensure documents meet regulatory requirements.
Research regulatory requirements and remain current in the regulatory landscape.
Share lessons learned, best practices, and ensure compliance with company training and reporting.

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Senior Associate - Scientific Writing

Job Description

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