Manager, Clinical Data Transparency

Johnson & Johnson

Manager Clinical Data Transparency ensuring clinical study integrity aligned with regulatory standards at Johnson & Johnson. Interacting with cross-functional teams and leading PLS production processes.

Posted 7/30/2026full-timeMumbai • 🇮🇳 IndiaMid-LevelSenior💰 €68,600 - €119,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in maintaining scientific integrity of clinical study results while ensuring compliance with regulatory standards. Possesses strong communication skills to effectively translate complex scientific content for lay audiences and lead cross-functional discussions.

Highest-signal resume keywords

Regulatory Clinical Trial Disclosure RequirementsMedical WritingPLS WritingLeadership on Cross-Functional ProjectsCustomer Focus and Solution-Oriented Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Results AnalysisVendor Quality MonitoringStatistical Analysis PresentationSOP ComplianceProject Metrics Identification

Soft Skills

Strong Oral/Written CommunicationInterpersonal SkillsOrganizational SkillsLeadership SkillsProblem Solving

Tools & Technologies

PLS TemplateJob AidsTranslation Systems

Industry Keywords

Pharmaceutical ExperienceHealthcare Subject AreaClinical TrialsHealth Literacy PrinciplesIntellectual Property Concerns

About the role

Key responsibilities & impact

maintaining the scientific integrity of clinical study results, aligned with J&J's compliance framework and regulatory standards, and deliver a summary that is understandable to lay readers in a fair, balanced, and non-promotional manner.
Ensuring PLS production process is robust and scalable.
Monitoring vendor quality to identify weak points and develop solutions
Interacting effectively with multiple functions, clinical teams across all Therapeutic Areas and external vendors to communicate document requirements and to provide high quality results
Ensuring compliance with departmental SOPs, Job Aids, policies and regulatory guidance documents
Leading discussions by proposing solutions on guidelines, standards, processes
Possessing sound organisational and leadership skills, and the ability to balance multiple responsibilities and work under tight time constraints
Vendor oversight, reviewing all draft PLSs, ensuring adherence to PLS compliance documents (i.e., PLS Template and Job Aid) and health literacy principles
Leading discussions with cross-functional teams to address and resolve content issues
Completing understanding of J&J's PLS policy and regulatory mandates.
Communicating effectively with team members to confirm studies qualify under internal policy and mandatory criteria (i.e., national and regional requirements including EU Clinical Trial Regulation [EU CTR])
Assessing impact of and applying, as appropriate, regional and/or local PLS content-related requirements and evaluates the impact with key stakeholders
Ensuring that results presentation is appropriate to the statistical analysis, and relevant for nonscientific readers, and includes sufficient context
Understanding the concerns around commercially confidential information, intellectual property and participant privacy issues in clinical trials
Collaborating with teams who publish clinical trial results for alignment
Preparing material and facilitating meetings with PLS production extended team members (i.e., PLS and ad-hoc Subject Matter Experts)
Facilitating the timely hand-off of PLS for translation to begin
Attending and actively participating in vendor(s) operational and governance meetings, raising issues to PLS Lead
Assisting in the updates of procedural documents, including the template, standard terms and definitions and Job Aids
Identifying relevant program metrics to qualify/quantify project benefit, identifying risks and areas of improvement
Possessing strong oral/written communication and presentation skills
Mastering the use of systems, tools, and processes

Requirements

What you’ll need

A Bachelor’s degree in a scientific, technical or healthcare subject area, or equivalent experience is required.
At least 5 years in relevant pharmaceutical/scientific experience in a related field; e.g. medical writing, PLS writing
Excellent understanding of at least one of the following: regulatory clinical trial disclosure requirements, translation of scientific content for a lay audience
Demonstrated written and verbal communications skills is required
Demonstrated customer focus and solution-oriented experience required
Proficient English written and spoken
Demonstrated interpersonal skills to build relationships with internal and external business partners
Demonstrated leadership on cross-functional projects.
Demonstrated leadership in strategic decision making and problem solving

Benefits

Comp & perks

an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
vacation days
parental leave for a minimum of 12 weeks
bereavement leave
caregiver leave
volunteer leave
well-being reimbursement
programs for financial, physical and mental health
service anniversary and recognition awards
employees - and in some locations eligible dependents - can participate in several insurance plans