Instagram
youtube
Facebook

Senior Associate Manager - Regulatory Writing

2+ years
Not Disclosed
10 Oct. 23, 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

Scientific Communications Associate - Regulatory

Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader based in Indianapolis, Indiana, our mission is to develop life-changing medicines, enhance disease understanding, and give back to our communities. We prioritize our people and seek individuals committed to making a positive impact.

Job Description

Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, healthcare professionals, payers, and patients is fundamental to our mission throughout the drug development lifecycle.

Role Purpose
The Scientific Communications Associate - Regulatory will collaborate with cross-functional teams to lead the development of documents intended for regulatory audiences, including clinical study reports, briefing documents, regulatory responses, Investigational New Drug Applications (INDs), and marketing authorization applications.

Minimum Qualification Requirements

  • Bachelor’s degree in a scientific, health, communications, or technology-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).

Lilly is committed to fostering an inclusive workplace. If you require assistance submitting your application due to a disability, please fill out the accommodation request form here.

Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

#WeAreLilly