Regulatory Scientist

Job Description

Job 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 (BD) 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.

Company Description

At AA2IT, we deliver solutions that align with your business goals, built on innovation, backed by a team of experts, and guided by measurable outcomes.

Company Description

At AA2IT, we deliver solutions that align with your business goals, built on innovation, backed by a team of experts, and guided by measurable outcomes.

Salary : $75