Senior Regulatory Data Analyst

Location: High Wycombe

Duration: 6 month contract (opportunity for contract extension)

Hours: 37.5 hours per week

Pay rate range: Competitive hourly rate (PAYE and Umbrella options available)

Working mode: Hybrid (1 day per week on-site in High Wycombe)

type of position:

Establish effective working relationships with GRA teams at global, regional, and local levels. Engage with key business partners and third parties as required, including suppliers, support teams, and Regulatory Authorities. Responsible for analysing and recommending improvements to business processes, regulatory information, data definitions, and technology with input from business domain experts. Scope includes alignment planning for business processes and tool/technology deployments.

impacts & outcomes:

Makes informed decisions that impact strategies for global regulatory operations. Influences and makes inputs to global decisions related to process improvements for standards, processes, technologies, and resource prioritisation. Provide innovative approaches and applies expert knowledge to ensure a structured and proactive approach to delivery of regulatory information management activities.

responsibilities:

Responsible for identifying and understanding complex problems; making recommendations and proposing appropriate scalable, sustainable solutions within a global organization. Works independently and contributes effectively to the PLcR team when making recommendations and decisions. This position may also lead others in making recommendations and solutions.

knowledge & skills:

• Expert level Data Analysis skills

• Demonstrable experience of Business Analytics

• Experience of Data Management

• Effective interpersonal, teamworking, and communication skills.

• In-depth knowledge of project management, database-driven information systems, and web/internet technologies.

• In-depth knowledge of regulatory information systems, regulatory planning, and publishing/submission tools.

• In-depth knowledge of global/regional regulatory and safety processes.

• General awareness of the drug development process and regulatory lifecycle.

• Comfortable working in a matrix environment; experienced at partnering with and influencing key stakeholders.

• Demonstrable skills for problem solving, troubleshooting, and adaptability.

• Knowledge of software development methodology, user acceptance testing practices, and related toolsets.

responsibilities:

• Reports to the Director.

• Works independently.

• Responsible for managing their workload and deliverables within time and quality constraints.

illustrative responsibilities:

• Enables the efficient operation and maintenance of key GRA business processes, including planning and tracking of regulatory submissions, and lifecycle and data management. Ensures timely and accurate updates for critical regulatory data items. Works with 3rd party suppliers and internal IT partners to deliver product registration improvement initiatives and business support materials. 

• Drives compliance with the relevant procedural documents, training requirements, and regulations. Assures the creation and delivery of these materials to meet changing business needs, applying change management procedures.

• Lead on the effective use of the regulatory data held in the various RIM systems to support business processes and to respond to requests. Works with owners and consumers to ensure correct interpretation of the users’ request for information.

• Input to design and development of RIM and PLcR business capabilities to meet the needs of the evolving regulatory environment. 

• Aligns and standardises regulatory data and processes taken from different sources, ensuring definition of ownership of the data and process, consistent use of terminology, and strong alignment between the owners’ and the consumers’ expectations.

• Works with all stakeholders involved in a process to ensure strong alignment of expectations, consistency of process and of roles, with a focus on quality of regulatory data.

• Undertakes validation activities for RIM-supported tools.

benefits

This role offers a very competitive hourly rate. This contract will run for 6 months and has a strong chance of extension. 

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE & Umbrella options are available. 

questions

If you would like some additional information about the role please contact: sara.marsalo@randstadsourceright.co.uk (please note that we do not accept applications via email).

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.