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: R&D Operations
Job Sub Function: Clinical Trial Project Management
Job Category:Professional
All Job Posting Locations:High Wycombe, Buckinghamshire, United Kingdom
Job Description:Job Description:About Johnson & JohnsonAt 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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
Johnson & Johnson's Innovative Health Engagement and Advocacy (IHE&A) organization has been created to drive substantial impact to participant health and wellbeing by reinventing the clinical trial experience. The Innovative Health Engagement & Advocacy organization connects teams across development to novel capabilities and solutions, igniting the potential of innovation to drive broader access to innovative medicines, and enrich the healthcare experience for all!
Position Summary:IHEA organization is seeking to hire a solution oriented, innovative and engaging member in their Patient Engagement Strategy team who will be responsible for integration and enhancing the compliance review process across Innovative Health Engagement and Advocacy (IHEA) including creating SOP and facilitating the successful implementation of the Compliance Review Committee (CRC). This role works reports to the Director, Patient Engagement Strategy and works closely with the Engagement Compliance, Patient & Site Engagement team, Advocacy, Clinical Research Equity, Study teams, and other applicable teams involved in patient or healthcare professional recruitment/retention and site support for our portfolio of studies. Additionally, this role works closely with compliance partners in RAP, HCC, Legal and Privacy. The primary focus of this role is to expand the forum to integrate all activities launched by IHEA, understand and support teams in the process of ensuring all materials, tactics, and content created for patient recruitment and retention purposes/site facing support tactics and materials are compliant and undergo the vital compliance review process.
Principal Relationships:- Contacts inside the company may include Regulatory Advertising and Promotion, Privacy, Health Care Compliance, Global Legal Organization, PDO, GCSO, and IT
- Contacts outside the company may include Patient Recruitment and Retention Vendors
Key Responsibilities:Manage and ensure all submissions meet compliance requirements and follow the appropriate workflow processes. Assign materials to appropriate reviewers in alignment with critical timelines. Track submission progress and outcomes and escalate issues to prevent process delays.
- Provide guidance and advice on process as it relates to the review and approval of tactics, applicable guardrails, new concepts, as well as resolving issues/requests from CRC partners.
- Provide daily compliance support to RAP, Legal, HCC, Privacy, PSE, and study teams, troubleshoot workflow issues based on user feedback and business needs and act as a key contact for users navigating the compliance review process
- Contribute to enhancing process functionality and implement optimizations in collaboration with end users and J&J Compliance partners (RAP, Privacy, Legal, HCC) and stakeholders.
- Facilitate weekly CRC meetings, including all new concepts and other topic identification and agenda preparation, scheduling with cross-functional teams (Legal, RAP, HCC, Privacy, PSE and Study Teams), documentation of decisions and action items via annotated PDFs.
- Actively support activities surrounding strategic and process related input into policies, procedures, and training related to compliance
- Maintain CRC SP site including forms, trackers, tools for end users and partners including ongoing communications related to updates, improvements or other needs. Support process for providing appropriate KPIs, Metrics and Dashboard for analysis, trending and resource needs.
QualificationsEducation:- Bachelor's degree is required, preferably in a scientific or health related field
Experience and Skills:Required:- Minimum of 3 years relevant experience in clinical trial related activities at a trial institution or with a pharmaceutical company and/or CRO and experience in compliance operations, workflow systems and platforms
- General knowledge of clinical trial operations, ICH GCP and regulatory environment
- Demonstrated ability to identify and implement process efficiencies/improvement
- Working knowledge of compliance driven Standard Operating Procedures (SOP) and drafting Work Instructions (WI)
- Ability to manage high volumes of data and workflows with precision and efficiency
- Demonstrated proficiency with Microsoft, Excel, Veeva Vault VTMF, Domino and system platforms
- Excellent communication and negotiation skills, with a demonstrated ability to communicate with and train stakeholders across matrix organizations
- Excellent written and verbal communication and presentation skills
Preferred:- Experience with Generative AI is highly preferred
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
Required Skills: Preferred Skills:Analytical Reasoning, Budgeting, Clinical Trial Management Systems (CTMS), Clinical Trials, Compliance Management, Contract Management, Execution Focus, Fact-Based Decision Making, Laboratory Operations, Mentorship, Process Improvements, Project Integration Management, Research and Development, Research Ethics, Standard Operating Procedure (SOP), Technical Credibility
