Associate Director, Therapeutic Area Lead - Infectious Diseases and Vaccines (IVD)-00000RQ8
Description
Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director, Therapeutic Area Lead, Infectious Diseases and Vaccines (IVD) in Horsham PA, High Wycombe UK, or Morris Plains NJ.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Associate Director, Therapeutic Area Lead, Infectious Diseases and Vaccines (IVD) will be responsible for a group of Scientist working to support Safety Management Teams (SMT). The incumbent will oversee compliance, quality, procedures, regulations, timeliness, and consistency of all deliverables which include; Scheduled Reports, Ad Hoc Reports and SMT support. In addition this role will be responsible for all Mergers and Acquisitions and Transition of work into the Business and Liaise with Regulatory regarding Policy/Regulations/Legislation. This is accomplished through employee recruitment, development and evaluation; cross-functional communication; and application of in-depth regulatory/safety knowledge. Partner with the Therapeutic Area Safety Head (TASH) for Infectious Diseases and Vaccines to manage the strategic messaging and safety profile of our products provided in all deliverables. Lead complex projects. Ensure Accurate and timely analyses and assessments of safety data for all deliverables
The Associate Director, Therapeutic Area Lead, Infectious Diseases and Vaccines (IVD) will manage (direct, train, motivate, evaluate) the scientific personnel in the Infectious Diseases and Vaccines TA to produce deliverables in compliance with current employment guidelines and policies. This includes guiding employees to use more effective program methodologies and grow in technological and procedural efficiency. S/he will manage resource needs and resource allocation based on workload to ensure appropriate compliance with report submissions, grow and develop resources, identify key talent in the Group, provide leadership and direction to the Infectious Diseases and Vaccines Group while assuring that all company procedures and global regulations for quality and timeliness are met, and establish credibility and working partnership with the TASH for Infectious Diseases and Vaccines to ensure that an AR processing voice is heard in interactions with GMSP. S/he will manage staff activities and be responsible for compliance with SOPs, global regulations/guidelines and corporate policies by scientific personnel. S/he will build and manage interrelationships with international and domestic regulatory groups as well as Local Safety Officers regarding the timely preparation and submission of deliverables to health authorities. S/he will lead all transition work required post any Merger or Acquisition and partner with Regulatory to review and comment on updated Regulations/Legislation.
Qualifications
A minimum of a Graduate Degree in Health or Biomedical Science (e.g.: MS, PharmD, MD, MPH or PhD) AND at least 7 years in drug-development OR a Bachelors Degree in Health or Biomedical Science with at least 10 years in drug-development OR an RN with at least 13 years in drug-development is required.
Working understanding of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements is desired.
Good Collaborative and communication skills are required.
Attention to detail along with strong scientific, analytical and conceptual skills is required.
Ability to understand complex medical-scientific data from a broad range of disciplines is required.
Understand aspects and methods for data analysis, interpretation and presentation is required.
Possess good working skills in MS Word, Excel and PowerPoint including statistics is required.
Medical Writing experience is desired.
IDV experience is desired.
There will be less than 10% travel.
This position will be located in Horsham PA, High Wycombe UK, or Morris Plains NJ.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Morris Plains
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Drug & Product Safety Science
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