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    Associate Director, Gra Precision Medicine & Digital Health

    Gsk Plc
    8+ years
    Not Disclosed
    Collegeville London Massachusetts
    10 Jan. 21, 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, GRA Precision Medicine & Digital Health

    Location Options:

    • Waltham, Massachusetts
    • Rockville, Maryland
    • London, United Kingdom
    • Collegeville, Pennsylvania
    • Wavre, Belgium

    Category: Regulatory
    Posted Date: November 20, 2024

    Company Overview

    GSK is a global biopharmaceutical company committed to uniting science, technology, and talent to get ahead of disease together. With a focus on vaccines, specialty medicines, and general treatments, GSK aims to positively impact the health of billions of people worldwide. The company operates in four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology.

    Role Overview

    The Associate Director, GRA Precision Medicine & Digital Health is responsible for developing and executing the regulatory strategy for precision medicine and digital health assets across GSK's therapeutic portfolio. This role requires working closely with cross-functional teams, including Regulatory Operations, Precision Medicine, and Digital Health, to ensure compliance with regulatory requirements and successful product life cycle management.

    Key Responsibilities

    1. Global Regulatory Strategy Development

      • Accountable to the Global Regulatory Leader (GRL) and Global Regulatory Science Precision Medicine Head for developing and delivering the Precision Medicine and Digital Health regulatory strategy across assigned assets.
      • Ensure timely execution of strategies, while working collaboratively within GSK, engaging with partners and regulatory agencies.
      • Lead regulatory interactions and review processes for precision medicine and digital health assets across the GSK portfolio.

    2. Regulatory Compliance and Lifecycle Management

      • Ensure compliance with regulatory requirements at every stage of the product life cycle, from C2MD to post-market.
      • Support global development, submission, and approval activities for in vitro diagnostics, companion diagnostics, and Software as a Medical Device (SaMD) products.
      • Conduct assessments of Precision Medicine and Digital Health components, particularly in the context of in-licensing opportunities.

    3. Collaboration and Stakeholder Engagement

      • Serve as a key point of contact for regulatory operations and work closely with internal teams and regional regulatory authorities.
      • Lead or participate in local/regional regulatory authority interactions, providing expert guidance and fostering strong partnerships.

    4. Leadership and Performance Management

      • Drive high-performance by setting clear, challenging goals for the team, focusing on continuous improvement and performance excellence.
      • Advocate for regulatory approaches to senior leaders within GSK and Health Authorities.

    Qualifications

    Basic Qualifications

    To be considered for this role, candidates should have:

    • Bachelor’s degree in biological science, healthcare science, or engineering
    • Minimum of 1 year of experience in the regulation of in vitro diagnostics, companion diagnostics, and/or SaMD within a pharmaceutical company in at least one major market
    • Minimum of 1 year experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in at least one major market

    Preferred Qualifications

    Candidates with the following qualifications will be given priority:

    • Master’s or PhD in biological science, healthcare science, or engineering
    • Experience leading global development, submissions, and approvals for precision medicine and digital health products
    • Proven communication skills, both written and verbal, with the ability to engage senior leaders and health authorities effectively
    • Ability to lead cross-functional teams, foster collaboration, and manage change in a dynamic environment
    • Strong problem-solving skills, capable of finding creative regulatory solutions while balancing the expectations of Agencies and ensuring compliance with regional regulations

    Why GSK?

    At GSK, we unite science, technology, and talent to advance public health. We offer:

    • Competitive salary and annual bonus based on company performance
    • Comprehensive healthcare and well-being programs
    • Pension plans and shares and savings programs
    • A flexible hybrid working model, offering both remote and in-office opportunities
    • A collaborative, inclusive work culture that values diversity and supports continuous growth

    Equal Opportunity Employer

    GSK is an Equal Opportunity Employer. We embrace diversity and are committed to providing equal employment opportunities regardless of race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, or veteran status.

    Application Instructions

    Interested candidates should submit a CV and cover letter that highlights how their experience aligns with the role's responsibilities and qualifications.

    Important Notice to Employment Agencies

    GSK does not accept referrals from employment agencies or third-party recruiters. All agencies must obtain prior written consent from GSK's HR or Procurement Department before submitting candidates.

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    Kuala Lumpur |

    Mexico :

    Ciudad de México |

    New Zealand :

    New Zealand |

    North Island :

    Auckland |

    Lima Region :

    Lima |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Mazovia :

    Warsaw |

    Remote :

    Faridabad | Castlebar | Springville | Lenexa | Zaragoza | Ireland | Nairobi | Remote - Middle East | Medan | Manipal | Riga | Remote | Tulsa | Remote, USA | Victoria | McFarland | Hungary | Switzerland | Bishop | Bountiful | Blue Bell | Remote - South America (Latin Americal) | Minnesota | Lousiana | Leinster | Slovakia | Remote - Europe | Melbourne | Remote - Africa | Thailand | Xzagreb | Texas | Belgium | Green Way | Hammond | French |

    Bucharest :

    Bucharest |

    Makkah :

    Riyadh | Najran | Rabigh | Khulais | King Abdullah Economic City | Jeddah |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |