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Senior Associate Manager - Regulatory Writing

2+ years
Not Disclosed
10 Nov. 19, 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

At Lilly, we combine caring with discovery to improve lives globally. We are a leading global healthcare company headquartered in Indianapolis, Indiana. Our employees work passionately to discover and deliver life-changing medicines, improve disease understanding and management, and contribute to communities worldwide through philanthropy and volunteerism. We are committed to giving our best effort, and we prioritize people first. We are looking for individuals who are determined to make life better for people around the world.

Scientific data and information are essential to Lilly’s mission. Providing balanced, objective, and accurate information to regulators, the scientific community, healthcare professionals, payers, and patients in a consistent and timely manner is central to our work throughout the entire drug development lifecycle.

The Scientific Communications Associate - Regulatory will collaborate with cross-functional, multidisciplinary teams to lead the development of regulatory documents. These documents include clinical study reports, briefing documents, regulatory responses, Investigational New Drug (IND) Applications, and marketing authorization applications.

Minimum Qualification Requirements:

  • Bachelor’s degree in a scientific, health, communications, or technology-related field.
  • Proven experience in technical/regulatory scientific writing.
  • Strong communication and interpersonal skills.
  • Successful completion of a writing exercise (required as part of the candidate evaluation process).

Lilly is committed to providing equal employment opportunities for individuals with disabilities. If you require accommodation during the application process, please complete the accommodation request form for assistance. Please note that this form is only for accommodation requests, and any other correspondence will not receive a response.

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

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