Associate Specialist - Regulatory Affairs (Hybrid)

Merck & Co.; Philadelphia (Philadelphia County); Ibrido; USD 72.000 - 113.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Dental insurance

Vision insurance

Retirement benefits (401(k))

Paid holidays

Vacation

Sick days

Descrizione del lavoro

Merck & Co. seeks an Associate Specialist in Regulatory Planning & Publishing to assist in planning, execution, and management of timely regulatory submissions. The role is based at the Philadelphia, PA WeWork Office in a hybrid schedule requiring 3 days in the office.

You will support FDA cover letters, submission plans, and document archiving, while coordinating with regulatory teams. The position emphasizes process improvement, document control, and timely deliverables, with a strong focus on

Competenze

• Ability to communicate effectively, both verbally and written with others across cultures and organizational levels.
• Demonstrates the ability to independently solve problems.
• Familiar with MS Office; Advanced Excel and Word skills preferred.
• Highly organized with keen attention to detail.

Mansioni

• 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.
• Participate in training courses to increase job role skills and regulatory knowledge.

Conoscenze

Accountability

Communication

Computer literacy

Customer satisfaction

Deliverables management

Document control systems

Independent thinking

Microsoft Word

Taking ownership

Working independently

Project Management

Formazione

High School Diploma or equivalent

Descrizione del lavoro

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.

Location and Schedule

This position is based at the Philadelphia, PA, WeWork Office, on a hybrid bases- 3 days in office; The incumbents will be required to commute to the Philadelphia, PA, WeWork 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

• 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.

Required Skills

Accountability, Communication, Computer Literacy, Customer Satisfaction, Deliverables Management, Document Control Systems, Independent Thinking, Microsoft Word, Taking Ownership, Working Independently

Preferred Skills

Project Management

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.

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

Salary Range

The salary range for this role is $71,900.00 - $113,200.00

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 https://jobs.merck.com/us/en/compensation-and-benefits .

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a