Currently I have an opening for a Regulatory Affairs & Clinical Safety Project Manager located in Rahway, NJ or West Point, PA (Hybrid schedule with occasional travel between sites). Details for the position are as follows:

Job Description:

• Under the minimal guidance of the Senior Director, Business Development Execution, the incumbent manages and is responsible for the business process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution.
• The primary function includes coordinating various GRACS functional areas, to ensure implementation and maintenance of regulatory activities associated with assigned Company Business Development (Client) Agreements. These agreements include but are not limited to divestitures, mergers/acquisitions, in-licensing, out-licensing, collaborations, public private partnerships, distribution, co-marketing, and authorized generic agreements. Facilitates the processes, communications, and governance to ensure GRACS contractual obligations and commitments are met while maintaining regulatory compliance.
• Work closely with the Corporate Business Development, MRL Global Alliance Management (MGAM), Integration Management Office (IMO) and GRACS Business Development to understand the partner agreements and the goals of those agreements throughout the lifecycle post signing.
• Responsible for establishing the GRACS Integration or Transition Team (comprised of functional Subject Matter Expert (SME)) through the recruiting and onboarding integration team members upon completion of the due diligence and understanding of the contract execution requirements for the deal.
• Following the GRACS Business Development Operating Model, performs all responsibilities of the GRACS Business Development Execution Lead (or Integration Lead for Acquisitions/Mergers/Collaboration or Transition Lead for divestitures) including facilitation of discussions with GRACS SME execution team to identify gaps and risks, track progress and coordinate ongoing updates of progress to ensure GRACS Leadership is informed as needed.
• Responsible for understanding contracts and working closely with the Corporate Business Development and MRL Alliance Management Teams
• Assess GRACS Integration related problem situations to identify causes, gather and process relevant information, generate possible solutions, make recommendations, and/or resolve the problem and direct the resolution of complex business problems.
• Ensure adherence to the established common network framework for GRACS functional areas to understand/evaluate business partner operations, establish guidelines for working together and leverage differences to create value, share best practices and deliver activities to drive knowledge transfer between GRACS team members.
• Provide training as necessary on successful partner relationship skills including process, collaboration, communication, and tools.
• Develop the functional alliance relationship to support effective business deal execution, engage partners and GRACS applicable personnel to explore the potential challenges of working together, examine differences, develop shared protocols for managing those differences, and establish mechanisms for their day-to-day work.
• Bachelor’s degree required. At least 12 years in the pharmaceutical industry with at least 5 years in Regulatory/Pharmacovigilance Function or Alliance or Business Development.
• Proven and demonstrated skills in project management and leadership, strategic, proactive, and a creative problem-solver that generates options and drive results in a deadline driven environment.
• Strong proficiency with generating content using all MS Office tools including but not limited to Word, Excel, Power-Point and SharePoint.

Technical Information:

• 12-month contract with potential for extension/conversion
• Pay: $70-78 hourly, depending on experience level
• Hybrid position, with travel between Rahway, NJ and West Point, PA