Location: Rockville,MD, USA
Site Name: USA - Massachusetts - Waltham, Rockville Vaccines, UK - London - New Oxford Street, Upper Providence, Wavre
Posted Date: Nov 20 2024
Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. This goal must be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process and policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data.
Responsibilities and Accountabilities (include expected deliverables, managerial and leadership responsibilities and performance standards):
Accountable to GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery. In this role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with Precision Medicine/Digital Health partners and regulatory agencies.
In addition, this role will serve to build and maintain the team's book of work, consisting of
This role works closely with members of the Regulatory Operations, Precision Medicine, and Unit Digital Health teams. Lead or participate in interactions with local / regional regulatory authorities.
In performing the role, the job holder will be responsible for:
* Ensure the development of appropriate global Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. Leading regulatory interactions and the review processes for GSK.
* Ensuring compliance with regulatory requirements at all stages of product life from C2MD.
* Ideally able to advocate persuasively approaches to senior leaders in GSK and in Health Authorities.
* Capable of providing assessment of Precision Medicine and Digital Health components leveraged for potential in-license molecules.
Competencies and Capabilities (include key high-performance behaviors). Challenges and questions ways of working to seek improved process.
Establishes team goals and uses to seek to improve performance, with ability to set challenging but realistic targets.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
* BS in biological science, healthcare science, or engineering.
* Minimum of 1 year experience in 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 at least one major market.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
* MS or PhD in a biological science, healthcare science or engineering.
* Led global development, submission, and approval activities. Organized and executed milestone meetings with Health Authorities
* Excellent communication skills, ideally in writing and verbally. Proven ability to deliver key communication with clarity, impact and passion. Commands attention and interest through use of appropriate communication techniques. Proven ability to foster strong matrix working. Capable of facilitating groups of individuals to work together on creating solutions. Ability to lead change and communicate difficult messages. Able to implement plans and hold self and team accountable for delivery of short and medium term goals.
* Ability to proactively recognize and resolve conflict and arbitrate as necessary, seeking help as necessary to ensure successful outcome. Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Will seek information from a broad range of sources, within and outside the normal range of enquiry to understand wider context.
* Proven ability to take sound decisions, often without complete information, or in situations where consultation with others is not possible due to situation or time constraints. In doing so, the job holder will use all available sources of information and weight benefits and risks before making important decisions.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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