Project Manager - MRL
Apply NowCompany: AA2IT
Location: Rahway, NJ 07065
Description:
Title: Project Manager - MRL
Rate: $75 / HR on W2
Regulatory Affairs (MRL, GRACS)
Education:
Minimum BS Degree preferably in technical, business or science.
Required Experience:
At least 12 years in the pharmaceutical industry with at least 5 years in Regulatory/Pharmacovigilance Function or Alliance or Business
Development.
Ability to influence and effectively operate in an ambiguous/rapidly changing environment while being quality and compliance oriented.
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 virtual and in person collaboration
Demonstrated facilitation and leadership skills.
Clear communicator and goal oriented.
Comfort and experience building and presenting effective slide presentations with audiences at all levels of the organization.
Independent thinker and worker.
Highly organized, motivated, and detail-oriented while still able to keep overall "big picture" view of projects and strategies.
Demonstrated analytical and data management skills. Experience pulling together abstract milestones and data into centralized management
report.
Demonstrated ability to lead cross functional teams and facilitate cross functional meeting to achieve a purpose.
Strong, demonstrated project management capabilities and skills.
Ability to collaborate and manage multiple projects at various stages of the process simultaneously.
Ability to communicate messages in a clear and concise manner both verbally and in writing.
Experience with change management concepts and execution.
Strong proficiency with generating content using all MS Office tools including but not limited to Word, Excel, Power-Point and SharePoint.
Some experience creating and modifying MS Teams and MS Project or related tools to manage project timelines and collaboration.
Brief Description of Position
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.
Work closely with the Mature Deals and Operations team to define, establish, and drive continuous improvement of the Business Process for the
pre and post execution phases of Business Development Agreements with focus on how the different GRACS functions and business partners
collaborate.
Specific to opportunities where an ongoing relationship is maintained with the business partner, the incumbent will be responsible for serving as
the point of contact for all alliance management issues related to ongoing GRACS activities.
If Interested, kindly share your CV with answers:
Q1-How many years of pharmaceutical industry exp and how many years of Regulatory/Pharmacovigilance Function or Alliance or Business
Development.
2-how many years of exp in GRACS implementation and maintenance of
regulatory activities associated with assigned Company Business Development (Client) Agreements
Q3: How many years of exp in establishing the GRACS Integration or Transition Team
Q4: This is in person position and the person can work from any locaiton ie Rahway NJ or West Point PA, Which location you want to work and how far you live from there
Q5: how soon you are ready to start and what is your best phone number to speak.
Rate: $75 / HR on W2
Regulatory Affairs (MRL, GRACS)
Education:
Minimum BS Degree preferably in technical, business or science.
Required Experience:
At least 12 years in the pharmaceutical industry with at least 5 years in Regulatory/Pharmacovigilance Function or Alliance or Business
Development.
Ability to influence and effectively operate in an ambiguous/rapidly changing environment while being quality and compliance oriented.
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 virtual and in person collaboration
Demonstrated facilitation and leadership skills.
Clear communicator and goal oriented.
Comfort and experience building and presenting effective slide presentations with audiences at all levels of the organization.
Independent thinker and worker.
Highly organized, motivated, and detail-oriented while still able to keep overall "big picture" view of projects and strategies.
Demonstrated analytical and data management skills. Experience pulling together abstract milestones and data into centralized management
report.
Demonstrated ability to lead cross functional teams and facilitate cross functional meeting to achieve a purpose.
Strong, demonstrated project management capabilities and skills.
Ability to collaborate and manage multiple projects at various stages of the process simultaneously.
Ability to communicate messages in a clear and concise manner both verbally and in writing.
Experience with change management concepts and execution.
Strong proficiency with generating content using all MS Office tools including but not limited to Word, Excel, Power-Point and SharePoint.
Some experience creating and modifying MS Teams and MS Project or related tools to manage project timelines and collaboration.
Brief Description of Position
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.
Work closely with the Mature Deals and Operations team to define, establish, and drive continuous improvement of the Business Process for the
pre and post execution phases of Business Development Agreements with focus on how the different GRACS functions and business partners
collaborate.
Specific to opportunities where an ongoing relationship is maintained with the business partner, the incumbent will be responsible for serving as
the point of contact for all alliance management issues related to ongoing GRACS activities.
If Interested, kindly share your CV with answers:
Q1-How many years of pharmaceutical industry exp and how many years of Regulatory/Pharmacovigilance Function or Alliance or Business
Development.
2-how many years of exp in GRACS implementation and maintenance of
regulatory activities associated with assigned Company Business Development (Client) Agreements
Q3: How many years of exp in establishing the GRACS Integration or Transition Team
Q4: This is in person position and the person can work from any locaiton ie Rahway NJ or West Point PA, Which location you want to work and how far you live from there
Q5: how soon you are ready to start and what is your best phone number to speak.