Director Medical & Regulatory Excellence

Johnson & Johnson; High Wycombe; On-site; GBP 80,000 - 120,000; Full time

Job summary

A leading company in healthcare innovation is seeking a Director of Medical & Regulatory Excellence in High Wycombe, UK. The role involves providing leadership across Regulatory Affairs and Medical Operations, ensuring strategic direction and operational efficiency. Candidates should possess significant experience in regulatory affairs and demonstrate strong leadership skills.

Qualifications

• Minimum 5-7 years of regulatory or medical affairs experience.
• Strong background in regulatory affairs.
• At least 4 years of line leadership experience.

Responsibilities

• Lead Regulatory Affairs, Medical Excellence, and Medical Operations.
• Define Medical Operational Benchmarks and oversee Quality System Management Review.
• Prepare annual business plan predicting future resource needs.

Skills

Regulatory Affairs

Project Management

Leadership

Cross-functional Team Leadership

Education

Degree in bioscience, pharmacy or medicine

Formal scientific training with MBA or PhD

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs

Job Category:

People Leader

All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

Job Description:

J&J is recruiting for a Director of Medical & Regulatory Excellence, located in High Wycombe, UK.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world!

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal-opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.

This role will provide leadership of Regulatory Affairs, Medical Excellence and Medical Operations for Johnson & Johnson Innovative Medicines UK, comprised of the following teams: Regulatory Affairs, Evidence Generation, Early Products, Medical Information and Medical Compliance.

The successful candidate will be primarily responsible for setting the strategic direction, tactical management and functional alignment of these departments, strive to improve the customer and business experience of Johnson & Johnson Innovative Medicine Medical teams through core process improvements.

This role is a core member of the Medical Leadership team (MLT) and takes a lead role in the implementation and execution of core business priorities.

Key Responsibilities:

• To improve connectivity and best practice sharing across Medical Affairs Therapy Areas and assist in the prioritisation and implementation of Regional and Global initiatives across these teams.

• Guide reporting teams to achieve efficient cross-functional working together well as with all other relevant departments to achieve/exceed company objectives.

• Define and have oversight of Medical Operational Benchmarks, and the bi-annual Quality System Management Review (QSMR), in line with EMEA MAF, CIE & Compliance requirements, to resolve Key Performance Indicators and measure operational efficiency and productivity of the department.

• Prepare annual business plan predicting future resource needs for the Medical Department. Assume accountability for the Medical Excellence budget.

• Ensure training and competency enhancement processes are developed and executed for the Medical Affairs function

• Be a present and strong leader during audits and inspections to ensure the strongest outcome for the company.

• To attract, develop and manage core regulatory talent, and build medical affairs operations skills to help create a diverse, high performing team.

• Play an active leadership role in relevant business meetings as agreed with Medical Director.

Qualifications

Education:

• Degree in bioscience, pharmacy or medicine or equivalent experience.

• Experience and Skills:

  Required:

• Minimum of 5-7 yrs. of regulatory or medical affairs proven experience in relevant roles.

• Strong background in regulatory affairs

• Several years of project management expertise; formal training and certification is a plus.

• At least 4 yrs. of line leadership experience.

• Excellent record in leading across-functional teams in a highly complex organization.

• Formal pharmaceutical (pharmacist) or medical education (physician, nurse) are a plus.

• Formal scientific training with MBA or PhD qualifications would also be beneficial.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.