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Alliance Diabetes & Obesity Crp

5+ years
Not Disclosed
10 Jan. 16, 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: Medical Affairs Specialist
Location: [Insert Location]

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, we are dedicated to discovering and delivering life-changing medicines, improving the management of diseases, and supporting our communities through philanthropy and volunteer efforts. We are seeking passionate individuals who are determined to improve lives worldwide.

Key Responsibilities:

Business/Customer Support:

  • Understand and anticipate the scientific information needs of local and regional customers (including payers, patients, and healthcare providers), addressing questions promptly by leading data analysis and clinical/health outcomes research efforts.
  • Contribute to medical strategies that support brand commercialization activities, collaborating closely with global Medical Affairs, brand teams, Global Patient Outcomes/Real World Evidence, global PRA, and other cross-functional teams in the development of local business plans.

Scientific Data Dissemination/Exchange:

  • Ensure compliance with local laws, regulations, and global policies regarding data dissemination and interactions with healthcare professionals.
  • Address unsolicited scientific information needs from external healthcare professionals, in accordance with compliance guidelines.
  • Support the preparation and review of medical information materials and letters in collaboration with medical information associates.
  • Establish and maintain collaborations with external scientific experts, thought leaders, and the broader medical community, both locally and internationally.

Clinical Planning, Research, and Trial Execution:

  • Represent clinical needs within the country/region in collaboration with business unit medical leadership for clinical strategies and development plans.
  • Review and approve local informed consent documents and risk profiles, ensuring clear communication of risks to study participants.
  • Collaborate with clinical research staff in the design, execution, and reporting of local clinical trials, including sample size determination, patient commitment, timelines, grants, and governance review.

Regulatory Support:

  • Contribute to the development and review of local labeling and labeling modifications in partnership with global Development, brand teams, regulatory, and legal teams.
  • Provide medical expertise to regulatory scientists and participate in advisory committees.

Scientific Technical Expertise:

  • Stay updated on current trends in clinical practice and access within the relevant therapeutic areas, both short-term (1-2 years) and long-term (3-5 years).
  • Critically evaluate medical literature and competitive products; stay informed about medical and scientific developments relevant to the product.
  • Serve as a scientific consultant and protocol expert to clinical study team members and other medical colleagues.

Qualifications & Experience Required:

  • Medical Doctor (MD) or Doctor of Osteopathy (DO). Must be board eligible or certified in the relevant specialty/subspecialty, or have completed comparable post-medical school clinical training relevant to the country of hiring.
  • Completed education at a medical school accredited by the Liaison Committee on Medical Education.
  • Fluent in English, both verbal and written.
  • Knowledge of the drug development process relevant to the country or region is preferred.
  • Strong communication, organizational, and negotiation skills.
  • Demonstrated ability to influence others and create a positive, collaborative working environment.

Additional Information:

Lilly is committed to fostering a diverse and inclusive workforce. We are dedicated to providing equal opportunities for individuals with disabilities to engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form on our website.

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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