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Medical Affairs – Medical Writing

2+ years
Not Disclosed
10 Oct. 16, 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 unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, our employees are dedicated to discovering and delivering life-changing medicines, enhancing disease understanding, and giving back through community philanthropy and volunteerism. We prioritize putting people first and are seeking individuals committed to making a positive impact globally.

Position Title: Medical Writing Specialist
Department: Medical Affairs

Purpose:

At Lilly, scientific data and information are invaluable assets. Our goal is to provide balanced, objective, and accurate information to regulators, healthcare professionals, payers, and patients throughout the drug development lifecycle. In a complex healthcare landscape, our Medical Affairs team stands out by delivering clear, credible answers that differentiate us from competitors.

Medical Affairs aims to be the preferred partner in the healthcare community, leveraging medical expertise to drive patient-centric solutions. This includes providing customized clinical and real-world evidence and supporting patients with educational resources and access to our medicines.

Primary Responsibilities:

Document Management and Content Development:

  • Collect and evaluate data from various sources to create a cohesive content strategy.
  • Plan, write, edit, and finalize regulatory documents supporting clinical development and product registration.
  • Conduct document initiation meetings to align the authoring team.
  • Present data clearly and accurately, ensuring consistency across related documents.
  • Coordinate expert reviews, incorporate feedback, and prepare final versions.
  • Ensure quality checks for accuracy and clarity.
  • Flexibly navigate the development of multiple document types.

Project and Stakeholder Management:

  • Lead the writing process with effective project management skills to meet deadlines.
  • Communicate project timelines and anticipate risks to ensure timely delivery.
  • Collaborate with teams and stakeholders for smooth document development, escalating issues as necessary.

Knowledge and Skills Development:

  • Maintain and enhance knowledge of therapeutic areas and regulatory guidelines.
  • Stay informed about the competitive landscape and evolving scientific communications.

Knowledge Sharing:

  • Coach others by sharing expertise and best practices.
  • Contribute to process improvements and database/tool expertise.

Minimum Qualifications:

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

Preferred Qualifications:

  • Graduate degree with research experience in life sciences.
  • Advanced proficiency in medical, scientific, or technical writing.
  • Expertise in specific therapeutic areas (e.g., oncology, neuroscience).
  • Experience in writing regulatory documents and Medical Affairs communications.
  • Proven project and time management skills.
  • High-level computer skills (e.g., word processing, spreadsheets, presentations).

Lilly is committed to fostering an inclusive work environment. If you require accommodations to apply, please contact Lilly Human Resources at Lilly_Recruiting_Compliance@lists.lilly.com. This email is solely for accommodation requests related to the application process; other inquiries will not receive a response.

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.

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