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Manager - Gra Global Labeling

4+ years
Not Disclosed
10 Nov. 19, 2024
Job Description
Job Type: Full Time Remote 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 are committed to making life better for people around the world. We are a global leader in healthcare, headquartered in Indianapolis, Indiana. Our dedicated team works tirelessly to discover and deliver life-changing medicines, improve disease understanding and management, and contribute to communities worldwide through philanthropy and volunteerism. We are driven by our purpose and seek individuals who are passionate about making a difference.

Purpose of the Role: As the Manager/Sr Manager, Global Regulatory Affairs (GRA) Global Labeling, you will provide leadership and technical expertise to guide labeling development and maintenance for Lilly’s products. This role requires strategic thinking, critical analysis, and cross-functional collaboration to drive results and ensure success in regulatory labeling activities. You will be responsible for the resourcing, staff development, and performance management of the labeling team while overseeing the completion of key projects and implementing process improvements.

Key Responsibilities:

  • Personnel Management and Leadership:

    • Lead and support the team by providing guidance on departmental policies, regulatory knowledge, and company objectives.
    • Coach, mentor, and empower staff to make informed decisions, resolve issues, and execute tasks efficiently.
    • Ensure staff receive appropriate training and recognition to foster growth and performance.
  • Strategic Planning and Implementation:

    • Align labeling strategies with corporate goals and affiliate priorities (U.S. and Canada).
    • Collaborate with internal stakeholders to evaluate and prioritize needs, driving continuous improvements in labeling processes.
    • Participate in business planning efforts and strategic initiatives.
  • Staffing and Resource Management:

    • Allocate resources effectively to support key projects and meet current and future needs.
    • Recruit, onboard, and integrate new team members to enhance organizational capabilities.
    • Foster cross-functional relationships to ensure coordinated support across departments.
  • Facilitate Labeling Processes:

    • Lead the labeling process by removing barriers to ensure activities are completed on time and in compliance with regulatory requirements.
    • Monitor changes in regulations and external environments to ensure adherence to current standards.
    • Share regulatory expertise with the team and stakeholders to maintain high standards in labeling practices.
  • Leadership and Collaboration:

    • Exemplify Lilly’s core values: Include, Innovate, Accelerate, and Deliver, both internally and externally.
    • Encourage open communication and collaboration across Global Regulatory Affairs and other Lilly teams.
    • Influence business decisions and foster discussions that lead to innovative solutions.

Minimum Qualifications:

  • Bachelor's or Master's degree in a scientific field (e.g., pharmacy, chemistry, or a related discipline).
  • 12+ years of experience in the pharmaceutical industry or regulatory affairs, including at least 4 years in team management.
  • In-depth knowledge of U.S. FDA/Health Canada and EMA regulatory procedures and practices.
  • Expertise in the drug development process and global regulatory guidelines.
  • Proven ability to work in a global matrix environment and communicate effectively with diverse teams.

Additional Preferences:

  • Project management experience with the ability to manage multiple projects simultaneously.
  • Strong negotiation and leadership skills.
  • Ability to work across multiple time zones to accommodate global teams (U.S./EU/Asia).
  • Supervisory experience and the ability to inspire and influence teams.

Why Lilly? At Lilly, we are deeply 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.

Lilly is an equal opportunity employer, and we do not discriminate based on 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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