Job Description

At Johnson & Johnson Innovative Medicine, we are recruiting a Manager, Real World Evidence Generation Operations for a 18 month contract to provide technical, scientific and program management expertise in the development and implementation of the Real-World Evidence (RWE) programs in the context of the Integrated Evidence Generation Planning (IEGP) process. This dynamic leader will technically lead the team of Evidence Generation Program Leads (EPLs) and supervise their day-to-day tasks, with a strong focus on sharing experience, standard procedures and build areas of technical expertise between the EPLs team. Building and maintaining the internal and external evidence generation/RWE network of Subject Matter Experts (SMEs) to support the setup and execution of EG programs will be under the remit of this Manager. Through collaboration with relevant partners, execution excellence of EG programs according to quality, budgetary and timeline specifications is a core responsibility for this role.
Key Responsibilities:

• Collaborate closely with Medical Science, Market Access and Regulatory leads providing operational planning, risk management and resource planning expertise at evidence generation program level (defined as portfolio of projects the support specific TA, disease, or indication).
• Provide technical leadership of the team of Evidence Generation Program Leads (EPLs) and supervise their day-to-day tasks, with a strong focus on sharing experience, standard procedures and build areas of technical expertise between the RWE EPLs.
• Ensure risk mitigation, contingency plans are developed for key activities, checked against available budget, and implemented as appropriate by EPLs.
• Support the EPL Team in establishing links and communication channels with all relevant partners involved in clinical research related activities.
• Share technical knowledge and provide input into core documents and respond to program- related questions. Continuously explore and give input to EG operational gaps, business solutions and technologies (e.g., programs, tools, systems, and applications) and collaborate with evidence generation strategy and execution lead to drive efficiencies and effectiveness across teams.
• Ensure publication plans are properly developed and implemented by the EPLs in collaboration with activity owners within timelines & budget.
• Ensure HCC, pharmacovigilance and legal requirements are fully understood, appropriately handled, and followed when planning projects, developing materials, implementing projects, and contracting vendors.
• Collaborate with finance to run budget planning, tracking, and reporting in accordance with finance reporting cycles. Coordinate evidence generation budget reviews with activity owners, functional leads and finance partners following each budget update cycle.

Education:

• BA/BS degree in Life Sciences or related scientific field (biology, medicine, pharmacy, etc.,) required.
• Advanced degree preferred (MSc, PhD, etc.).

Experience and Skills:

• Proven leadership skills and ability to lead diversified team and stakeholders.
• Scientific and technical thought leadership with knowledge or learning agility to rapidly acquire understanding of health care compliance, study execution, pharmacovigilance, clinical/medical drug development, benefit risk management and regulatory affairs.
• Excellent interpersonal skills with a heightened ability to collaborate and work with a team to be successful.
• Highly innovative with the ability to drive multiple projects within a sophisticated and changing environment, and efficiently handle and resolve issues within the project management team.
• Highly motivated individual with demonstrated analytical, communication and interpersonal skills.
• A keen data science curiosity and strong leadership skills are required in our ambitious, fast-paced work environment.
• Ability to work effectively with multi-cultural and virtual teams.
• Highly adept in utilization of project management tools and reporting systems (including project CRMs, financial reporting system)

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.

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