Manager, Clinical Data Transparency (Plain Language Summary)
Location: United Kingdom (High Wycombe) or India (Mumbai/Bangalore)
Company: Johnson & Johnson (J&J)
About Johnson & Johnson
At Johnson & Johnson, we aim to profoundly impact health for humanity through innovative healthcare solutions. By leveraging expertise in Innovative Medicine and MedTech, we deliver smarter, less invasive, and personalized treatments to tackle complex diseases. Join us in building a healthier future.
Role Overview
The Manager, Clinical Data Transparency will play a critical role in ensuring clinical trial results are summarized in plain language, enabling accessibility and comprehension for lay readers. The position focuses on maintaining scientific integrity while complying with regulatory standards and J&J's internal policies.
Key Responsibilities
Plain Language Summary (PLS) Expertise:
Interpret regulatory guidance (e.g., EU Clinical Trial Regulations) to produce accurate, non-promotional PLSs.
Summarize clinical study results using source documents such as protocols, Clinical Study Reports, and informed consent forms.
Ensure PLS aligns with study rationale, objectives, and outcomes, and is scientifically accurate yet easily understood by non-technical audiences.
Process Management:
Establish a robust and scalable PLS production process, including vendor quality monitoring and improvement.
Oversee the development, implementation, and adherence to compliance documents (e.g., PLS templates, job aids).
Collaborate with clinical teams, therapeutic area experts, and vendors to ensure the timely delivery of PLSs.
Regulatory Compliance & Stakeholder Engagement:
Apply regional and local regulatory requirements to PLS content.
Facilitate meetings with cross-functional teams to address and resolve content issues.
Ensure adherence to J&J's PLS policies, including addressing commercial confidentiality and participant privacy concerns.
Leadership & Oversight:
Provide oversight for vendors, ensuring high-quality PLS drafts.
Organize and lead team discussions, including operational and governance meetings.
Update procedural documents and templates as needed to reflect evolving practices and standards.
Training & Metrics:
Train teams on PLS production, compliance, and health literacy principles.
Define and track program metrics to evaluate process efficiency, identify risks, and highlight areas for improvement.
Qualifications & Experience
Required:
Bachelor’s degree in a scientific, technical, or healthcare field (or equivalent experience).
Minimum of 5 years of experience in pharmaceutical/scientific domains, particularly medical or PLS writing.
Strong understanding of regulatory clinical trial disclosure and translation of scientific content for lay audiences.
Demonstrated expertise in written and verbal communication.
Proficient in written and spoken English.
Preferred:
Leadership experience in cross-functional projects and strategic decision-making.
Ability to build and maintain relationships with internal and external stakeholders.
Benefits
Competitive salary and extensive benefits package.
Career development opportunities within an inclusive and supportive environment.
Health and well-being initiatives for employees and their families.
Equal Opportunity Employment
Johnson & Johnson is committed to creating an inclusive workplace. All qualified applicants will receive equal consideration regardless of race, religion, gender, sexual orientation, age, disability, or veteran status.
Accommodations: Reasonable accommodations for candidates with disabilities are available during the application or interview process.
How to Apply
For more information and to apply, visit Johnson & Johnson's careers website.
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