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Gsc Scientific Communications Associate - Regulatory

0-2 years
Not Disclosed
10 Feb. 18, 2025
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

Job Title: GSC Scientific Communications Associate - Regulatory

Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full-Time, Regular
Job ID: R-70873


About Eli Lilly and Company:

At Eli Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader based in Indianapolis, Indiana, with employees working across the globe to discover and deliver life-changing medicines, improve disease management, and give back to communities through philanthropy and volunteerism. We seek individuals who are determined to help make life better for people everywhere.


Job Purpose:

The Scientific Communications Associate - Regulatory is responsible for the development of documents intended for regulatory audiences, supporting clinical development and product registration. This involves working with cross-functional teams to lead the creation of key regulatory documents, such as protocols, amendments, and informed consent forms (ICFs).


Primary Responsibilities:

Content Strategy and Execution:

  • Collect and evaluate data from multiple sources to develop a cohesive strategy for writing projects.

  • Plan, write, edit, review, and finalize regulatory documents, ensuring data is presented clearly and accurately.

  • Coordinate expert reviews, collate feedback, and adjust document content based on internal/external input.

  • Collaborate with internal and external experts, ensuring quality checks are performed for accuracy.

Project and Stakeholder Management:

  • Lead the writing process, ensuring timely completion of high-quality regulatory documents.

  • Anticipate risks and ensure smooth development of documents, escalating issues as necessary.

  • Communicate project status and ensure stakeholders are aligned on timelines and progress.

Knowledge and Skills Development:

  • Maintain and enhance knowledge of therapeutic areas and compounds for assigned projects.

  • Stay updated on regulatory guidelines and industry best practices.

  • Develop expertise in scientific communication skills, aligning with audience needs and technological advancements.

Knowledge Sharing:

  • Provide coaching to others and share technical information and best practices.

  • Network across functions to share best practices and contribute to process improvements.


Minimum Qualifications:

  • Bachelor's degree in a scientific, health, communications, or related field.

  • Demonstrated experience in technical or regulatory scientific writing.

  • Strong communication and interpersonal skills.

  • Successful completion of a writing exercise (required as part of the evaluation process).


Other Information:

  • Workplace Accommodation: Lilly is committed to ensuring equal opportunities for individuals with disabilities. If you need accommodation during the application process, please visit Workplace Accommodation.

  • Equal Opportunity Employer: Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.


How to Apply:

Interested candidates can apply directly through Lilly's career portal.