Associate Specialist, Portfolio & Program Management - Hybrid

Job Description

The Associate Specialist of Regulatory Planning & Publishing works closely with various stakeholders of regulatory and safety submissions to assist in activities related to planning, execution, and management of delivery of high quality and timely regulatory submissions.  

The responsibilities of the incumbent may include the following:

• Maintain accountability for use of established planning and tracking practices and systems.  

• Participate in pilots for new tools and processes.

• Collaborate with colleagues inside and outside of the department, as appropriate Participate in training courses to increase job role skills and regulatory knowledge

Program:

• Support in the creation of FDA cover letters and forms, creation of submission plans, assist in tracking deliverable timelines of components, and archiving in systems

Shared Services: (Associate Specialist)

• Provide regulatory submission/systems support. Manage regulatory documents, assisting in tracking timelines/deliverables and/or components and promptly responding to updates

Education Minimum Requirement:

• High School Diploma or equivalent (no relative experience)

• Ability to communicate effectively, both verbally and written with others across cultures and organizational levels Demonstrates the ability to independently solve problems that arise within job responsibilities and expectations of this role Familiar with computer systems. Highly organized individual with keen attention to detail

• MS Office necessary

• Advanced Excel and Word skills preferred

Desired Experience, Education & Skills:

• Demonstrated leadership, initiative, and ownership of deliverables

MSJR 

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is loc