Johnson & Johnson Careers

Manager PV Alliance Contracting

High Wycombe, United Kingdom
Business Development


Job Description

Requisition ID: 1805651104W


Janssen Research & Development, a part of the Johnson & Johnson family of companies, is recruiting for a Manager, Pharmacovigilance Alliance Contracting, Alliance and External Affairs, Strategy and Partner Oversight, Global Medical Organization located in the United States or 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.

We are Janssen.

Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Job Description

Provides support and oversight for GMO and OCMS in the negotiation, contractual management, and operational maintenance of 3rd Party Pharmaceutical Pharmacovigilance Agreements (PVAs) at the local level:

• In collaboration with PVA COE and other GMO/OCMS functional lines, drive relevant planning, execution, and governance of local PVAs.
• Provide overall standardization and centralization activities for local PVA deliverables and priorities.
• Contributes to local PVA process improvement initiatives.

PRINCIPAL RESPONSIBILITIES:

PVA development – lead and support the entire lifecycle in the end-to-end process of development, negotiation, execution, maintenance, and termination (when applicable) of local PVAs and associated deliverables in partnership with Local Safety Offices (LSOs):

• drafting the PVA utilizing the template as a guide
• lead reviewer/organize local PV review by internal/external stakeholders and collation of comments
• arrange meetings for conclusions and finalization on terms
• track local PVA workflow throughout the lifecycle within PVA COE tracking tool/system
• lead/assist in local PVA signatures and post agreement execution activities
• communication of PVA execution to all stakeholders including contact list updates
• extract local PVA information onto summary tables based upon PVA obligations
• answer local PVA queries and triage as appropriate
• lead/assist in local PVA revisions as per biennial review cycles
• contribute to PSMF quarterly review of local PVAs/commercial agreements
• participate in joint operations and tactical meetings on local PVAs and oversight parameters
• perform gap analyses for local PVAs as needed, with guidance, for audit and inspection remediation activities
• Contributes to tactical approaches and drive more effective operational plans for local PVA negotiation and execution.
• Participates and supports the implementation of process/ technology improvements that increase efficiencies and effectiveness to support local PVAs

PVA development – lead and support the entire lifecycle in the end-to-end process of development, negotiation, execution, maintenance, and termination (when applicable) of local PVAs and associated deliverables in partnership with Local Safety Offices (LSOs):
o drafting the PVA utilizing the template as a guide
o lead reviewer/organize local PV review by internal/external stakeholders and collation of comments
o arrange meetings for conclusions and finalization on terms
o track local PVA workflow throughout the lifecycle within PVA COE tracking tool/system
o lead/assist in local PVA signatures and post agreement execution activities
o communication of PVA execution to all stakeholders including contact list updates
o extract local PVA information onto summary tables based upon PVA obligations
o answer local PVA queries and triage as appropriate
o lead/assist in local PVA revisions as per biennial review cycles
o contribute to PSMF quarterly review of local PVAs/commercial agreements
o participate in joint operations and tactical meetings on local PVAs and oversight parameters
o perform gap analyses for local PVAs as needed, with guidance, for audit and inspection remediation activities
• Contributes to tactical approaches and drive more effective operational plans for local PVA negotiation and execution.
Participates and supports the implementation of process/ technology improvements that increase efficiencies and effectiveness to support local PVAs.

Qualifications

• A minimum of a Bachelor’s degree is required (graduate level highly preferred) in a relevant discipline; Medical, or additional Business or Legal qualification is of interest

• At least 5 years of experience in a regulated or drug safety department or equivalent pharmaceutical regulatory environment is desirable

• Experience in Pharmacovigilance Agreement concepts and practices are preferred

• Proven experience in group facilitation - ability to lead and drive teams to make decisions & achieve deliverables within agreed parameters & timelines

• Demonstrated problem solving ability

• Strong organizational and coordination skills. Demonstrated experience in program management, preferably in pharmaceutical business environment.

• Requires proficiency with contract language and standard legal terms and conditions for commercial contracts.

• Excellent presentation, writing communication and computer skills. Excellent negotiation and networking skills.

• Applied knowledge of applicable Law and Regulations governing Pharmacovigilance on global level (e.g., HIPAA, EU PV Legislation, Code of Federal Regulations) is desirable.

• Project management, process excellence, and/or experience improving processes in a complex, global environment is preferred

• Ability to work across cultures, and establish successful working relationships at all levels within the organization




 


Primary Location
United Kingdom-England-High Wycombe
Organization
Janssen Cilag Ltd. (7360)
Job Function
Business Development
Requisition ID
1805651104W