Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

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.