Associate Insurance & Sponsorship - Global Clinical Operations

Description

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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Beerse - Belgium, Leiden - the Netherlands - Requisition Number: R-063361

High Wycombe, United Kingdom - Requisition Number: R-063940

Spring House - Pennsylvania, USA - Pennsylvania, USA - Requisition Number: R-063943

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Johnson & Johnson is currently seeking an Associate Insurance & Sponsorship to join our team.

This position is accountable for the success and execution of assigned/delegated tasks to support Insurance, Delegation of Authority & Sponsorship Compliance (IDSC) activities in management of global clinical trials within agreed timelines and expected level of quality, in alignment with all the applicable SOPs and regulatory requirements, with support and oversight. Alignment of goals with organizational objectives as defined within Global Development organization.

Principal Responsibilities:

• Performs the day-to-day IDSC activities, with oversight and guidance from senior level staff in accordance with internal standard operating procedures, global health authority regulations and good clinical practices.
• Performs assessments of clinical study protocols against insurance policy exclusions to ensure there are no potential conflicts with the insurance policies.
• Process requests for clinical trial insurance and collaborate with broker/insurer to provide finalized insurance documentation for EC/HA submissions.
• Draft and finalize delegation documentation based on approved general, country specific, or CRO templates, as applicable, based on the structure of the trial.
• Review and approve documentation related to JCI /JBV sponsorship of clinical trials, according to GCO SOPs.
• Respond to questions from stakeholders relating to specific requests & IDSC processes and requirements.
• Contributes to Ethical Committee (EC) and HA responses and queries for assigned area of responsibility.
• Assists in the gathering and maintenance of intelligence information and document templates in support of IDSC activities.
• Manage insurance premium payments by creating and updating vendors in the system, processing premium invoices, ensuring completion of required Anti‑Money Laundering (AML) documentation, and addressing payment‑related questions
• Captures data, as applicable, to track day-to-day activities.
• In collaboration with senior level staff, supports development of training and awareness sessions to internal and external partners and stakeholders.
• Contributes to process improvement initiatives.
• Contributes information required for Health Authority (HA) inspections and internal Quality Assurance (QA) audits.
• This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.

Education and Experience Requirements:

• Bachelor’s degree or equivalent preferred (preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy)) or business experience.
• Minimum of 2 years clinical trial management experience in the pharmaceutical industry or CRO, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
• Working knowledge of the clinical development process is preferred.
• Excellent communication skills (both oral and written) required.
• Ability to work effectively in cross-functional teams, participating on global teams in a virtual environment.
• Strong organizational skills, ability to prioritize and accomplish a large volume of work required.
• Ability to contribute to the productivity and cohesiveness of the team required.
• Fluent in English

Principal Relationships:

Contacts inside the company may include: central and local study teams, Clinical, Legal, Risk Management, JCI/JBV Board Members, Finance, Global Regulatory Affairs, Contract Specialists, Procurement, NCC Office, IT, eBIS, across all Therapeutic Areas within the Research and Development/Operating Company.

Contacts outside the company may include: Global Insurer, Insurance Broker, Clinical Research Organizations, Vendors

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Preferred Skills: