Job Description
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-
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Current Contingent Workers apply HERE
US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
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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 located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
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
Search Firm Representatives Please Read Carefully- 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: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Hybrid
Shift: 1st - Day
Valid Driving License: No
Hazardous Material(s): N/A
Job Posting End Date: 02/12/2025
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R333407
Job Tags
Full time, Local area, Remote job, Relocation, Visa sponsorship, Flexible hours, Shift work, 3 days per week,