Assoc. Spclst. Regulatory Affairs

Job Description

Department
Regulatory Planning and Publishing (RPP)

Brief Description of Position

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.

This position is based at the Rahway NJ Office on a hybrid bases- 3 days in office; The incumbents will be required to commute to the Rahway NJ Office for these 3 days.

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: (Regulatory Submission 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

Required Qualifications Skills & 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 (MS Office necessary; Advanced Excel and Word skills preferred)

• Highly organized individual with keen attention to detail

Desired Experience & Skills:

• Demonstrated leadership

• Takes initiative

• Ownership of deliverables

#MSJR

Required Skills:

Preferred Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Job Posting End Date:

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