Johnson & Johnson Careers

Associate Director, Safety Reporting

Horsham, Pennsylvania; High Wycombe, United Kingdom
Clinical Trial Administration


Job Description

Requisition ID: 3461190828

Janssen Research & Development LLC., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Safety Reporting.  This position can be located in Horsham, PA or High Wycombe, United Kingdom.

 

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. 

 

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com for more information.

 

The Associate Director, Safety Reporting will lead a global function charged with providing critical operational services for outbound safety reporting to Investigators, Ethics Committees/Institutional Review Boards (IRBs) worldwide in support of over 300 clinical trials in over 30+countries that span across the R&D portfolio, including in-house and outsourced trials as appropriate.  This position will report to the Director, Safety Reporting.

 

This role will include oversight of a team that is accountable for the timely distribution of safety reports to all investigators and Ethics Committees/IRBs worldwide for Janssen Pharmaceuticals. Reports distributed include SUSARs, SUSAR Line Listings and Development Safety Update Reports (DSURs).  The Safety Reporting Team will provide outbound safety reporting services related to in-house as well as fully outsourced clinical trials for Janssen.

 

Principal Responsibilities:

  • Provide strategic, technical and operational leadership over the Safety Reporting team to ensure focus on delivery of safety reporting services and projects within timelines, within budget and with high quality.

  • Business Owner for operational safety process and system.
  • Establish strong cross-functional partnership with Global Clinical Development Operations (GCDO), Global Medical Safety Operations, compliance and clinical teams to ensure an integrated process that is efficient, effective with built in quality.

  • Establish strong partnership with technology teams to ensure necessary integration of data through technology solutions to drive single source of data and automation, where possible.

  • Lead the Safety Unit so that execution is done according to protocol, International Guidelines for Good Clinical Practice (GCP).

  • Ensure that the department Standard Operating Procedures (SOPs) are maintained and are following Global and local regulations.

  • Maintain a high performing team through on-going development, performance management and coaching.

  • Take ownership for ensuring strong pipeline of leaders within the organization through succession planning process and foster colleague empowerment, engagement, inclusion and CREDO behaviors.

  • Set up strategic and operational objectives for the Safety Reporting Unit ensuring alignment of these with the overall targets and objectives of the bigger organization.

  • Promote a quality culture, ensuring audit readiness within the team.


Qualifications
  • A minimum of a Bachelor’s or equivalent University degree is required, preferably in a Scientific or Engineering discipline.  An advanced degree (Masters, MBA) is preferred.

  • A minimum 10 years of healthcare industry experience in operations or service organizations is required.

  • A minimum of 3 years of people leadership experience is required.
  • Experience mentoring, coaching and/or developing team members is required.

  • Experience managing global and remote employees preferred.
  • Experience in safety, pharmacovigilance and/or clinical operations preferred.

  • Knowledge of the clinical trials process is required.
  • Working knowledge of Clinical Trials Safety Reporting requirements with respect to Investigators and Ethics Committee/ Institutional Review Board (IRB) is preferred.

  • Experience in process improvement and/or project management is preferred.

  • Must have excellent oral and written communications skills.

  • Must have effective leadership skills and proven ability to foster team productivity and cohesiveness.

  • Must have strong negotiation and problem-solving skills.

  • The ability to analyze and structure problems, evaluate options and quickly define a path forward for self and teams is required.

  • The ability to assess risk and apply risk-based approaches is required.
  • The ability to challenge the status quo to continuously improve current processes in support of lean, effective, customer focused processes is required. 

  • The ability to collaborate with all levels of management and influence decision-making in a global, matrix environment is required.

  • This position will require up to 10% domestic and international travel.

 

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.


Primary Location
United States-Pennsylvania-Horsham-
Other Locations
Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization
Janssen Research & Development, LLC (6084)
Job Function
Clinical Trial Administration
Requisition ID
3461190828