Data Standards and Governance Manager
il y a 1 semaine
Site Name:
USA - Pennsylvania - Upper Providence, Belgium-Wavre, UK - Hertfordshire - Stevenage
Posted Date:
Mar 9 2023
LOCATION:
Upper Providence, PA USA - Stevenage, UK - Belgium - Hybrid
Are you energized by the challenge of shaping and accelerating the digital strategy in the CMC space? Do you enjoy working with matrixed teams to deliver regulatory compliance? If so, the
Data Standards and Governance Manager:
IDMP could be an exciting role to consider.
Job Purpose
This role provides expert support ensuring the development, implementation and timely availability of consistent, high quality scientific data standards and governance deliverables supporting the acquisition, analysis and reporting of scientific data.
The primary focus of this role will be aligned to IDMP (Identification of Medicinal Product) implementation in the CMC space working closely with a global matrixed team.
Details
(_Your Responsibilities_
):
- This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following _
- Lead and contribute to scientific data standards and governance definition, implementation and support including the development and maintenance of associated metadata, documents, business rules and guidelines including IDMP implementation
- In collaboration with representatives across disciplines in R&D, Tech, and PSC, ensure the accurate translation of scientific requirements into efficient, compliant standards spanning the full asset lifecycle
- Partner closely with data generators, scientific experts, data managers, data scientists, Tech and other business stakeholders to make sure our data is timely, robust, trustworthy and compliant.
- Act as an expert consultant providing data standards and governance input to all relevant IDMP areas including; business systems, regulatory, clinical, substance&ingredients, supply chain, and comms and change
- Lead efforts for IDMP implementation within CMC which will include creating and executing roadmaps, project plans, and ensuring maturity models are reflective of the work being completed
- May represent GSK within industry wide associations and working groups; contributing to regulatory guidelines, industry practices and professional standards development organizations such as Allotrope and Pistoia
- Establish and set up global policies, frameworks, methodologies and platforms for access and security, data sharing, integrity and quality along the endtoend data flows and lifecycle, from generation/acquisition to use and reuse
- Accountable for developing required documentation to ensure CMC is IDMP compliant
_ Why you?_
Basic Qualifications:
- We are looking for professionals with these required skills to achieve our goals:_
- Minimum 5 years in a pharmaceutical or related industry space
- Minimum 1 year lab experience
- Bachelor of Science degree
- Experience with the Chemistry Manufacturing and Controls (CMC)data landscape ie development through to New Product Introduction (NPI)
Preferred Qualifications:
- If you have the following characteristics, it would be a plus:_
- Uptodate experience and expertise in data and information management, quality and governance with a strong focus on strategy and delivery.
- A proven leader with experience leading data and digital initiatives in complex, diverse, matrix environments and a track record of change management
- Superb communicator, networker and influencer who can challenge and shape how things are done. Ideally, you have a good understanding of scientific R&D processes, along with data security and privacy considerations
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.
Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.
We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orient-
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