Job Description

Main responsibilities CLINICAL RESEARCH (STRATEGY)

• Works closely with cross-functional project teams to identify clinical development plans in support of assigned innovation projects for Selfcare.

• Lead integrated evidence generation across RWE, Phase IIIb/IV, HEOR for Selfcare
• Insight generation to build NPD pipeline for Selfcare and drive evidence generation.
• Responsible for the Clinical Evidence Generation strategy to advance TA and Product science.
• Build and execute the Publication plan (clinical data generated from clinical trials, review articles, posters, expert opinion, consensus recommendation, guidelines)
• To act as a medical and clinical expert including innovative product and claims development.
• Contributes to claims generation, development of Brand Medical strategies and NPD Launch Strategies.
• Provide strategic oversight to the Investigator Initiated Studies (IIS)

CLINICAL RESEARCH (OPERATIONS)

• Responsible for successful execution and delivery of clinical studies in assigned clinical projects.
• Provides clinical guidance and strategic input in the choice and design of clinical study methods.
• Plans and directs clinical studies to ensure delivery of key study milestones
• If medically qualified, provides medical oversight on assigned clinical studies.
• Monitors and reports findings to senior management and facilitates understanding of clinical trial results.
• To lead discussions and implement plans for clinical development programs
• To independently initiate and manage operational aspects of company sponsored clinical trials in accordance with Johnson & Johnson global standards/guidelines and international regulations (GCP/ICH), including oversight, budget and timelines and act as liaison with study sites and external service providers as needed.
• To ensure all clinical activities are conducted in accordance with high ethical/quality standards and all applicable GCP/ICH regulations and company procedures
• To plan, develop, manage, review and update expert reports (i.e. common technical documents CTDs and clinical evaluations) and expert statements as required in the development of new products and during product life-cycle maintenance/product care.
• To co-author clinical protocols as required in the development of new products.
• Building understanding of latest thinking and trends in the field, build and execute clinical trial with novel trial designs and endpoints.
• Generate insights and identify areas for evidence generation through HCP interaction/ scientific advisory board meetings.
• Awareness of new developments in RWE analytics, data, and technology which may be applied to the design and execution of observational research.
• Manage specific ISS and support facilitation of ISS.
• Provide medical and scientific expertise to support product launches, key scientific meetings, relationship management with leading research physicians and critical evaluation of current literature.
• Has significant knowledge in the statistical and clinical interpretation of study results and broad knowledge of regulatory requirements for drug development.
• To assist Regulatory Affairs in submission activities within assigned projects and contribute to the preparation of submission documents to regulatory agencies, be the point of contact for Health Authority communication.

MEDICAL AFFAIRS

• Oversees high scientific quality communication with Leading Specialists, KOLs, Surgeons, Regulatory Agencies and medical Societies to communicate value of J&J Selfcare products, host formal discussions and understand key needs, key value drivers, practical treatment patterns, scientific activities.
• Oversees response to unsolicited scientific queries of customers for approved products and products/indications in development based on Medical Affairs and Medical Information documents
• Acts as an internal medical consultant to provide expert medical support to commercial and HCC partners
• Contributes to developing vision and executes initiatives for analyzing treatment paradigms, discussing J&J products, supporting regulatory approval/ clearance, health technology assessment, monitoring patients’ treatment trends as well as studies in therapeutic areas and engagement of Leading Specialists (Physicians, Pharmacists, medical societies ) and stakeholders
• Initiates, develops and executes Selfcare Medical Affairs projects
• Develops, plans and oversees execution of Medical Education programs and activities
• Organizes and participates in Advisory Boards
• Provide medical training and scientific support to stakeholders
• Provide medical and scientific expertise to support product launches, key scientific meetings, relationship management with leading research physicians and critical evaluation of current literature
• Checks scientific data provided locally to HCPs/ Authorities/ Regulators for compliance to regulations
• Reviews and approves medical, promotional, market access and other informational material for country consumption
• Contributes to claims development strategies and implementation for new and marketed products
• Has significant knowledge in the statistical and clinical interpretation of study results and broad knowledge of regulatory requirements for drug development
• Collaborates in developing responses to Health Authority queries and requests for information.

Stakeholder Engagement

• Engage with external stakeholders such as opinion leaders, research organizations and database owners
• Identify a range of suitably qualified and experienced vendors and suitable data sources to meet the different real-world evidence (RWE) generation requirements
• Drive collaboration amongst multiple stakeholders (Global / Region) and markets to efficiently generate impactful evidence and successfully achieve strategic objectives.

Work Assignments

• Assist in proactive local key opinion leader management.
• Ensures all activities are conducted in accordance with high ethical/quality standards and all applicable policies and procedures.
• Manages clinical programs in order to successfully achieve strategic objectives.
• Contributes to development and implementation of local medical strategies and claims support, copy and label reviews, review/approve communications for consumers and healthcare professionals, as well as the operational execution of complex programs and initiatives.

Qualifications
Required Competency and Skills:

• An advanced degree (e.g., PhD or PharmD or MD) is required. An MD or equivalent is preferred
• At least 3 to 5 years clinical research and medical affairs experience is preferred
• Solid professional knowledge of medicine and of scientific methods applied to clinical research
• Strong commitment to compliance with relevant rules and procedures, and to scientific quality and integrity
• Strong collaboration and interpersonal skills
• Results oriented and able to independently create and deliver
• Strong communication and presentation skills
• Strong leadership skills
• Knowledge in relevant local and international standards for the conduct of clinical studies
• Decision making and Problem Solving Skills
• Excellent verbal and written communication
• Ability to translate strategy into tactics
• Ability to work in a matrix environment with local, regional, and global cross-functional teams is essential
• May require up to 10% annual travel

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements, and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of a new entity within New Consumer Health.

Primary Location
Singapore-Singapore-Singapore-
Organization
Johnson & Johnson Pte. Ltd. (8435)
Job Function
R&D
Requisition ID
2206066677W