Associate, Sponsorship Oversight

at  Johnson Johnson

This position is accountable for the support of Sponsor oversight activities for Janssen-Cilag International NV within agreed timelines and expected level of quality, in alignment with all the applicable SOPs and regulatory requirements.
Alignment of goals with organizational objectives as defined in the GCO cascades.

EDUCATION AND EXPERIENCE REQUIREMENTS:

• achelor’s degree or equivalent preferred (preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy)) or relevant business experience as determined by the hiring manager.
• Minimum of 2-4 years’ experience in the pharmaceutical industry, CRO, HA/EC, study site, (or equivalent required.
• Working knowledge of the clinical development process is preferred.
• Ability to work effectively in cross-functional teams and to participate on global teams in a virtual environment.
• Strong organizational skills, ability to prioritize and accomplish a large volume of work required.
• Excellent communication skills (both oral and written) required.
• Fluency in English is required.
  About Johnson & Johnson
  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 https://www.jnj.com/.
  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.
  For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
  We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation

• Organize and facilitate the JCI Board Meetings, including scheduling and other logistical activities. Responsible for drafting agenda and capturing meeting minutes and following up with Board and attendees on action items through to resolution.
• Serve as primary point of contact for JCI Board related matters.
• Manage JCI related correspondence including but not limited to the following areas: correspondence from health authorities, invoices, importation, patient letters, etc. Consult with appropriate stakeholders for resolution, where needed.
• Prepare study and product related documentation, including securing signatures and legalization, where required. (i.e. Delegation of Authority Letters, Insurance certificates, Clinical Trial Agreements, Price Certificates).
• File and archive appliable study and product related documentation, both electronically and hard copy, in accordance with local records management requirements.
• Manage JCI Board SharePoint and document warehouse.
• Perform periodic review of documents related to JCI Governance, including Principles of Collaboration, JCI General Information, etc.
• Process New Marketing Authorization Requests for EMEA Emerging Markets.
• Support preparation and execution of internal and external audits/inspections.
• Training and oversight of Compliance Hub staff.
• May support other Insurance, Delegation of Authority & Sponsorship Compliance (IDSC) tasks, as assigned.
  Principal Relationships:
  Contacts inside the company may include: JCI Board of Directors, Legal, Global Regulatory Affairs, IDSC, Global Delivery Leaders, Global Delivery Managers, Global Clinical Trial Assistants, R&D Quality,
  External contacts may include Government Officials in and outside of EMEA for legalization of study documentation and Marketing Authorization application correspondence.