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Medical Writing - Medical Affairs

5+ years
Not Disclosed
10 Jan. 28, 2025
Job Description
Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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 Writing - Medical Affairs
Location: Bangalore, Karnataka, India
Job Type: Full-Time, Regular
Job Id: R-77901

About Lilly
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and deliver life-changing medicines, enhance the understanding and management of diseases, and give back to communities through volunteerism and philanthropy. We strive to make the world a better place by putting people first. We are looking for determined individuals to join our team and help us continue making a global impact.

Position Overview
The Medical Writing role within Medical Affairs involves creating and reviewing scientific content that supports regulatory submissions, clinical development, product registrations, and medical communications across the entire lifecycle of drug development. The role focuses on delivering clear, accurate, and balanced scientific content for various stakeholders including regulators, the scientific community, healthcare professionals, payers, and patients. The medical writer will be responsible for document preparation, content strategy execution, and managing project timelines to ensure high-quality, timely delivery.

Key Responsibilities

  • Content Strategy & Execution:

    • Collect and evaluate data from multiple sources, functions, and regions to develop a cohesive content strategy.
    • Prepare, write, edit, and finalize regulatory documents, supporting clinical development and product registration.
    • Build scientific rationale to support complex and strategic documents.
    • Ensure accuracy, consistency, and clarity of key data, statements, and conclusions across related documents.
    • Coordinate expert and scientific reviews, incorporate feedback, and prepare final versions of documents.
    • Maintain flexibility to move across different types of documents and therapeutic areas.
  • Project & Stakeholder Management:

    • Lead the writing process, applying effective project management skills to ensure timely completion of regulatory documents.
    • Create and communicate project timelines, ensuring alignment with internal and external teams.
    • Anticipate and mitigate risks, escalating issues to ensure smooth project completion.
    • Maintain regular communication with stakeholders on project status and updates.
  • Knowledge & Skills Development:

    • Stay current with therapeutic area knowledge, regulatory guidelines, and scientific communication techniques.
    • Demonstrate knowledge of the compound and therapeutic area, participating effectively in clinical planning and regulatory responses.
    • Maintain awareness of external environments, including competitors, to inform communication strategies.
    • Enhance scientific communication skills to adapt to changes in technology and platforms.
  • Knowledge Sharing:

    • Provide coaching and guidance to colleagues and team members.
    • Share technical expertise and best practices with cross-functional teams.
    • Contribute to process improvements and the optimization of document management systems.

Qualifications & Experience

  • Required:

    • Bachelor’s degree in a scientific, health, communications, or technology-related field.
    • Demonstrated experience in technical or regulatory scientific writing.
    • Strong written and verbal communication skills in English.
    • Successful completion of a writing exercise as part of the candidate evaluation process.
  • Preferred:

    • Graduate degree with a formal research component or in life sciences.
    • Expertise in a specific therapeutic area (e.g., oncology, immunology, cardiovascular, neuroscience, etc.).
    • Experience writing regulatory clinical trial documents, publications, and Medical Affairs communications (e.g., slide decks, patient or HCP materials).
    • Familiarity with clinical development, clinical trial processes, and regulatory activities.
    • Strong project management and time management skills.
    • Proficient in computer software (e.g., word processing, spreadsheets, presentations, graphics, and tables).

Additional Information
Lilly is committed to supporting individuals with disabilities in the workforce and ensuring equal opportunities during the hiring process. If you require accommodation to submit your resume or during the application process, please complete the accommodation request form on our careers page.

Lilly is an equal opportunity employer and 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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