Associate Director, Licensing & Acquisition (BioResearch Quality & Compliance)
Location:
Spring House , Pennsylvania
Posted:
January 12, 2017
Reference:
3222161208/2-en-us

Janssen Pharmaceutical Companies of Johnson & Johnson is currently recruiting for an Associate Director, Licensing & Acquisition that can be based remotely anywhere in the US or onsite at any Johnson & Johnson site in the US. The position will also require travel up to 25%.

 

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. 

 

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

 
The Associate Director, Licensing & Acquisition will:
 
  • Be a member of the Quality Planning & Strategy (QP&S) Licensing & Acquisition (L&A) group in BioResearch Quality & Compliance (BRQC) Janssen.
  • 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 GxP aspects of cross-pharma L&A, mergers and acquisition (M&A), and out licensing opportunities.
  • Proactively monitor L&A environment to continuously adapt and deliver L&A quality support strategies that maximize 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) to lead and coordinate GLP, GCP and medical safety compliance assessment activities with business partners & interface with JBD/Scientific Licensing project leads to report potential quality risks for consideration during L&A or M&A.
  • Lead cross-GxP initiatives to enhance the overall Pharma L&A support strategy as assigned by the Head of Licensing & Acquisition in support of L&A End to End strategy.
  • Manage the coordination of and participate in (as applicable) Johnson & Johnson Enterprise sponsored post-acquisition assessment (PAA) activities in compliance with corporate quality policies.
  • Review and provide BRQC Janssen input for L&A, M&A, and out-licensing contract negotiations as part of the Janssen Business Development 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 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
  • 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. 


Qualifications
  • A minimum of a Bachelor’s degree (Science, Engineering or Business preferred) or equivalent is required
  • A graduate degree (M.B.A., M.S., etc.) is desired.
  • A minimum of 8 years’ experience in a highly matrixed, FDA regulated environment is required
  • Knowledge of multidisciplinary areas of clinical development is highly preferred, including but not limited to: clinical operations, pharmacovigilance reporting, regulatory operations, contract development, clinical trial portfolio planning etc.
  • Experience managing multiple projects simultaneously is required.
  • Experience making decisions independently and ensuring confidentiality of business critical activities is preferred.
  • Strong knowledge of the drug development process, worldwide/applicable GCP compliance regulations, and quality evaluation techniques are preferred
  • Knowledge of clinical trial medical safety requirements is preferred
  • Strong knowledge of the drug development process, worldwide GCP compliance regulations, GxP quality systems, and data integrity is highly preferred
  • Familiarity with legal and financial good business practices is preferred
  • Previous experience focusing on Licensing, Mergers and Acquisitions (L&A/M&A) in the pharmaceutical industry is a plus.
  • This position can be based remotely anywhere in the US or onsite at any Johnson & Johnson site in the US. The position will also require up to 25% travel. 


Primary Location
United States-Pennsylvania-Spring House
Other Locations
North America-United States
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D

A little about us:
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