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Gsc Scientific Communications Associate - Regulatory

0-2 years
Not Disclosed
10 Feb. 6, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

GSC Scientific Communications Associate - Regulatory

📍 Location: Bangalore, Karnataka, India
🗓️ Job Type: Full Time, Regular
🆔 Job ID: R-70873

About Lilly:

At Lilly, we unite caring with discovery to improve lives worldwide. We focus on discovering and delivering life-changing medicines while contributing to global health improvements. Lilly's commitment to employees includes professional growth, development opportunities, and a supportive, inclusive work environment.

Purpose:

The Scientific Communications Associate in Regulatory will support the development of essential documents intended for regulatory audiences. This role is crucial in creating balanced, accurate, and clear documents that are integral to the drug development process, ensuring proper communication across various stakeholders.

Primary Responsibilities:

  1. Content Strategy & Execution:

    • Collect and evaluate data to develop a cohesive content strategy for writing projects.
    • Author, edit, and finalize regulatory documents such as protocols, amendments, and informed consent forms (ICFs).
    • Lead the writing process and ensure documents are scientifically sound, accurate, and aligned with data.
    • Coordinate expert reviews, incorporate feedback, and finalize documents.
  2. Project & Stakeholder Management:

    • Lead the writing and ensure timely completion of high-quality regulatory documents.
    • Communicate timelines, anticipate risks, and ensure smooth development with stakeholders.
    • Address and escalate issues as necessary to meet deadlines.
  3. Knowledge & Skills Development:

    • Maintain and enhance knowledge in therapeutic areas, diseases, compounds, and regulatory guidelines.
    • Stay updated on the latest industry developments, publication guidelines, and submission strategies.
  4. Knowledge Sharing:

    • Coach others, share technical knowledge, and contribute to process improvements.
    • Share best practices and provide guidance in document development.

Minimum Qualification Requirements:

  • Education: Bachelor’s degree in a scientific, health, communications, or technology health-related field.
  • Experience: Proven experience in technical or regulatory scientific writing.
  • Skills: Strong communication, interpersonal, and organizational skills.
  • Writing Exercise: Successful completion of a writing exercise is part of the evaluation process.

Why Choose Lilly?

  • Inclusive Workplace: Lilly is committed to creating an inclusive environment where all individuals have equal opportunities.
  • Growth & Development: Opportunities for career progression, learning, and skills development.

How to Apply:

Interested candidates are encouraged to apply for the position on the Lilly careers site.