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    Associate Director - Clinical Regulatory Scientist (Cmh/Neuro)

    Eli Lily
    5+ years
    Not Disclosed
    Cork
    10 Jan. 29, 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: Associate Director - Clinical Regulatory Scientist (CMH/Neuro)
    Location: Cork, Ireland
    Category: Research & Development
    Job Type: Full-time, Regular
    Job Id: R-76052

    About Eli Lilly:

    At Eli 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 team of over 45,000 employees is dedicated to discovering and bringing life-changing medicines to those who need them, improving the understanding and management of diseases, and giving back to our communities through philanthropy and volunteerism. At Eli Lilly Cork, we bring together a diverse group of employees who contribute to innovative solutions across a variety of business functions, including Finance, Information Technology, Medical, Clinical Trials, and more.

    Eli Lilly Cork offers a premium workspace across our Little Island campus, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies, and on-site parking. Our holistic benefits include People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives to enhance the career experience for our colleagues.

    We are committed to fostering diversity, equity, and inclusion (DEI) and ensuring an inclusive environment for employees of all backgrounds, including those with visible and invisible disabilities.

    Job Summary:

    The Associate Director - Clinical Regulatory Scientist will lead and provide direction for the regulatory and scientific support for Lilly products at the Cork GBS site. This position involves strategic input, leadership, and collaboration across cross-functional teams to ensure timely, high-quality regulatory submissions and activities. The role is also responsible for managing staff, overseeing regulatory processes, and identifying process improvements while aligning with the company's goals.

    Key Responsibilities:

    1. People Management:

    • Recruit, develop, and retain a high-performing, diverse workforce.
    • Ensure completion of required training for direct reports and support staff development through mentorship and coaching.
    • Promote a culture of innovation, inclusivity, and team collaboration.
    • Empower staff to make informed decisions, resolve issues, and execute tasks efficiently.
    • Align resources based on portfolio prioritization and geographical needs.

    2. Regulatory Delivery:

    • Align regulatory and labeling strategy with priorities set by molecule teams.
    • Support the evaluation of regulatory and submission strategies, ensuring alignment with internal and external customer needs.
    • Lead cross-functional communication, issue escalation, and delivery of regulatory support.
    • Leverage regulatory expertise to drive decision-making and collaborate with upstream work units to share best practices.
    • Monitor external regulations and stay updated on evolving requirements.

    3. Facilitation of Regulatory Processes:

    • Oversee the completion of regulatory activities in compliance with regulatory and quality system requirements.
    • Provide guidance on regulatory process questions and share expertise with the team.
    • Partner with quality teams to implement process improvements and resolve deviations.
    • Facilitate proactive staff development in regulatory and labeling activities.

    4. Effective Management:

    • Model leadership behaviors aligned with regulatory excellence and innovation.
    • Foster an environment for open discussions to address issues and achieve robust business decisions.
    • Ensure compliance and maintain a state of inspection readiness across the regulatory team.
    • Participate as a member of the site leadership team, contributing to overall strategic direction.

    Minimum Qualifications:

    • Education: Bachelor’s Degree in a scientific or health-related field (Master’s or PhD preferred).

    • Experience:

      • At least 5 years of experience in a leadership role in the pharmaceutical industry, preferably within regulatory affairs.
      • Strong understanding of regulatory processes and experience coordinating cross-functional teams.
      • Proven ability to manage and prioritize multiple projects, including people management and team development.
      • Ability to anticipate systemic problems, diagnose root causes, and take corrective actions.
      • Experience in coaching, mentoring, and empowering teams.

    • Skills:

      • Strong leadership and negotiation skills with the ability to influence teams and stakeholders.
      • Excellent communication skills (verbal and written).
      • Demonstrated ability to embrace diversity and inspire innovation.
      • Ability to manage conflict and resolve issues constructively.
      • Strong organizational and problem-solving skills with a focus on process optimization.

    Additional Preferences:

    • Experience managing global regulatory teams and collaborating across geographies.
    • Knowledge of US and Canadian regulations and regulatory submission requirements.
    • Ability to manage multiple projects and work in a dynamic, fast-paced environment.
    • Flexibility to adapt to changing priorities and business needs.
    • Willingness to travel as required for the role.

    Other Information:

    • Location: Cork, Ireland (with hybrid working options).
    • Travel: Domestic and international travel may be required.

    Eli Lilly is an equal opportunity employer:

    Eli Lilly is dedicated to fostering a diverse and inclusive workforce. We are committed to creating an environment that provides equal opportunities to all individuals, regardless of age, race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status. If you require accommodation to submit your application, please use the accommodation request form.

    #WeAreLilly 

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