Johnson & Johnson Careers
Manager, BRQC Licensing & Acquisition
Requisition ID: 00001DK5
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Manager, BRQC Licensing & Acquisition. This position can be based in any U.S Janssen location or international Janssen sites in Belgium and the Netherlands.
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.janssen.com for more information.
The Manager, BRQC Licensing & Acquisition will lead and coordinate with key business partners the process for quality review and input during due diligence, post-signing assessment and integration activities for the discovery research, GLP, GCP and medical safety compliance aspects of cross-pharma L&A, mergers and acquisition (M&A), and out licensing opportunities.
In this role, you will lead the development of clinical quality agreements between Janssen R&D and key external development partners.
Responsibilities include but are not limited to:
- Proactively monitor L&A environment to continuously adapt and deliver L&A quality support strategies that improve quality input to business partners to assure the best possible assets and companies are being acquired by Johnson & Johnson.
- Function as a member of cross-functional due diligence teams led by Janssen Business Development (JBD) of the Innovation Centers (IC) to lead and coordinate discovery research and pre-clinical assessment activities with business partners & collaborate with JBD/Scientific Licensing project leads to report potential quality risks for consideration during L&A or M&A.
- Review and provide BRQC Janssen input for L&A, M&A, and out-licensing contract negotiations as part of the JBD/IC team to assure quality language is included to allow for appropriate mitigation activities post signing.
- Manage a BRQC Janssen library of quality language to be suggested for master service agreements during the L&A contracting process.
- Lead the discussion, development and approval of clinical quality agreements between counterparts from co-development organizations (e.g. Pharmaceutical companies, Cooperative Groups, Governmental Agencies) and key internal stakeholders (e.g. BRQC Janssen, Therapeutic Areas, Global Clinical Development Organization etc.) to establish a quality oversight framework for assets jointly developed between Janssen R&D and external organizations.
- Manage/participate on cross-functional teams of key Pharma Segment R&D business partners to drive the BRQC Janssen post-signing assessment process including planning, execution and tracking of key quality risks for newly acquired products/companies.
- Support/Manage the coordination of and participate in (as applicable) Johnson & Johnson Enterprise sponsored post-acquisition assessment (PAA) activities in compliance with corporate quality policies.
- Coordinate with BRQC Janssen leaders to provide resource estimates for support of L&A, M&A, and/or out-licensing mitigation and base business activities post deal signing as necessary.
- Develop and maintain the appropriate relationships between internal and external scientific teams within the framework of an alliance.
- Lead/facilitate the training of BRQC Janssen staff and external business partners related to the conduct of pre-clinical or clinical due diligence, L&A and M&A quality assessment and mitigation as necessary.
- Lead cross-GxP initiatives to enhance the overall Pharma L&A support strategy as assigned by the Head of Licensing & Acquisition.
- Provide mentoring, coaching and development to individuals on the BRQC Janssen L&A Quality Support team.
- A Bachelor’s degree (Science or Business preferred) or equivalent is required. Graduate degree/studies in related discipline/ MBA a plus.
- A minimum of 8 years’ experience in the healthcare industry is required.
- Operational quality and/or quality assurance or equivalent time and experience in a related R&D area is required.
- Requires knowledge of multidisciplinary areas of preclinical and clinical development
- Knowledge of GLP compliance regulations is required.
- Experience pharmacovigilance reporting, regulatory operations, contract development, clinical trial portfolio planning etc. is preferred.
- Experience managing multiple projects simultaneously is required
- Experience making decisions independently and ensuring confidentiality of business-critical activities is required
- Strong knowledge of the drug development process, worldwide GCP compliance regulations, clinical trial medical safety requirements, quality evaluation techniques and scientific and quality terminology is preferred.
- Strong conflict management/negotiation skills preferred
- Strong networking and relationship building skills is a must.
- Experience working with multidisciplinary and cross functional leaders (director level and above) is preferred
- Familiarity with legal and financial good business practices is preferred
- This position may include up to 20% domestic and international travel as business demands.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are
equal opportunity employers, and all qualified applicants will receive
consideration for employment without regard to race, color, religion, sex,
sexual orientation, gender identity, genetic information, national origin,
protected veteran status, disability status, or any other characteristic
protected by law.
United States-Pennsylvania-Spring House
Europe/Middle East/Africa-Netherlands, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Malvern, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-California-La Jolla
Janssen Research & Development, LLC. (6084)