Job Description
Description
The candidate will be part of our company's Global Regulatory & CMC organization supporting the Americas Site CMC team located at the Wilson site. Site CMC is a key component of our strategy to build effective linkage between the CMC organization and our Manufacturing Division.
Reporting to the Sr. Director, Americas Site CMC, this role will support the conformance of our products with the approved Marketing Authorizations and will support change control and regulatory submission activities associated with the Wilson site.
Primary responsibilities include but are not limited to:
- Correctly identifies and assesses change controls for potential regulatory impact and requirements.
- Collaborates with CMC functional teams to progress regulatory post-approval changes efficiently through to market approval and implementation.
- Ensures information included in CMC filings aligns to site information and practices to support on-going and future dossier compliance and maintenance.
- Confirms that regulatory information is correctly maintained, updated, and interpreted, using our regulatory business processes, systems, and tools.
- Provides CMC guidance and direction to site Quality, Technical, and Supply Chain functions to ensure that product is released in accordance with the established Global Marketing Authorizations.
- Connects site and product strategy through engagement in CMC product and site-based project teams including new product/new market launch teams.
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Other activities include:
- Coordinates submission component authoring for post-approval CMC changes, new applications, and responses to Health Authority (HA) questions with site SMEs and CMC product leads.
- Participates on CMC product teams, to provide site strategy, source documents, and data requirements for CMC submissions.
- Participates in product / project teams with significant regulatory impact, e.g., product transfer, facility upgrades.
- Support HA notifiable events, investigations, and deviations with potential regulatory impact.
- Serve as CMC point contact for site GMP HA inspections
Education Minimum Requirement:
- Bachelor's degree in a science, engineering, or a related field (advanced degree preferred)
Required Experience and Skills:
- Required at least five (5) years of relevant experience in the Bio/Pharmaceutical industry
- The candidate must have a good understanding of and experience working with internal commercial manufacturing organization and/or contract manufacturing organizations. He / she must be able to effectively manage the competing demands of site and corporate stakeholders.
- Must have a proven ability to communicate effectively in both a written and verbal format.
- Ability to influence and work both independently and collaboratively in a team structure, including 'virtual teams.
- He/she will demonstrate effective problem solving, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks.
- Proven ability to work well under pressure.
Preferred Experience and Skills:
- Knowledge of global regulatory requirements and understanding of regulatory strategies is highly desired.
- Knowledge of commercial packaging activities including change control and product lifecycle management.
- Preferred at least 3 years of CMC-related experience. Candidates without direct CMC experience will be considered where they possess a technical and scientific background and have prior experience of engagement with Regulatory CMC projects and Regulatory Agencies.
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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:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
11/4/2024
*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:R318621