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Associate/Senior Associate/Lead - Regulatory Writing

0-2 years
Not Disclosed
10 June 4, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Job Title: Associate / Senior Associate / Lead - Regulatory Writing
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full-Time, Regular
Job ID: R-87544

Company Overview:

Eli Lilly and Company (Lilly) is a global healthcare leader committed to improving lives through innovation, research, and compassionate care. Headquartered in Indianapolis, Indiana, Lilly aims to discover and deliver life-changing medicines.


Role Purpose:

The Scientific Communications Associate - Regulatory will contribute to the creation of accurate, objective, and balanced documents for regulatory audiences, supporting clinical development and product registration. This role involves collaboration with cross-functional teams and focuses on producing high-quality scientific regulatory documents.


Primary Responsibilities

1. Content Strategy and Execution

  • Author, edit, and finalize clinical regulatory documents (e.g., protocols, amendments, informed consent forms).

  • Lead initiation meetings and integrate feedback from cross-functional teams.

  • Ensure consistency and scientific rationale across all content.

  • Manage document quality checks and version control.

  • May collaborate with external vendors or alliance partners.

2. Project and Stakeholder Management

  • Use project management skills to meet writing deadlines.

  • Mitigate project risks and escalate as needed.

  • Communicate timelines and project status to stakeholders.

3. Knowledge and Skills Development

  • Maintain expertise in assigned therapeutic areas.

  • Stay updated on regulatory and scientific communication standards.

  • Support strategic planning efforts (e.g., clinical or submission strategies).

4. Knowledge Sharing

  • Coach and support team members by sharing expertise.

  • Contribute to process improvement and tool usage.

  • Promote best practices across teams and regions.


Qualifications

  • Bachelor’s degree in a scientific, healthcare, communications, or technology-related field.

  • Demonstrated experience in technical or regulatory scientific writing.

  • Strong communication and interpersonal skills.

  • Successful completion of a writing exercise (mandatory for evaluation).


Inclusivity Statement

Lilly is an equal opportunity employer committed to diversity, inclusion, and providing accommodations to applicants with disabilities.