Job Description
Academic Training / Experience / Knowledge / Foreign Language:
Bachelor's degree in supply chain, pharmaceutical sciences, business administration, regulatory affairs, or a related field.
1 to 3 years of experience in the pharmaceutical industry, with exposure to new product introduction, SKU change management, project management, regulatory affairs, or related roles.
Basic understanding of pharmaceutical product development processes, regulatory requirements, and commercialization strategies.
Strong organizational and task management skills, with the ability to prioritize and meet deadlines.
Proficiency in data analysis tools and techniques.
Effective communication and interpersonal skills, with the ability to work collaboratively with team members and stakeholders.
Proficiency in Microsoft Office Suite and other relevant software.
Proficient in the use of business software (including MS Excel, MS PowerPoint, MS Project).
Business-level English
Role Description
The Specialist - Product Change Management & Implementation is part of the Product Portfolio Management, reporting to the Product Change Management & Implementation Lead. This role involves providing support to ensure compliance with network and source changes, as well as regulatory-driven artwork changes, for the international (ex-US) allocated customer business line. The specialist will collaborate with various departments, including Human Health, Supply Planning, Demand Management, SC Fulfillment, Market Planning, internal/external manufacturing sites, Regulatory Affairs, Global Artwork, Serialization, Master Data, Finance, Global Logistics, and Quality. Attention to detail, strong organizational skills, and the ability to work effectively in a collaborative environment are required.
Primary activities include, but are not limited to:
Leading cross functional teams, managing complex information flow, coordinating, and integrating the functional/ tactical project management activities for Network Changes and Regulatory driven changes with Artwork impact, in close collaboration with Value Chain Management, Product Source management and partner with E2E Planners, other Supply Chain functions, and stakeholders across divisions. Coordinate activities to mitigate risks related to the different milestones across the SKU change management and implementation stages including, but not limited to: Code Creation, Initial RCT update, Forecast Positioning, Artwork Readiness, First Packaging/ Pack-by Readiness, in line with the Regulatory Implementation Definition, last packaging to guarantee successful post approval change by ensuring system readiness to allow execution. Responsible for and providing end to end visibility for all projects within assigned product portfolio to all stakeholders throughout all divisions of the company. Coordinate activities to mitigate risks related to Artwork Readiness. Liaise with Regulatory Affairs, Artwork Centers, and Quality for timely execution Drive process improvement initiatives when needed Track and report KPls mitigating risks to minimize impact to business; participate and provide input to the IBP process (Demand Reviews, Site Supply Reviews) Understand & translate the packaging lead times, capacity issues, process reliability issues, sourcing flows, market specific requirements (e.g., TOI, shelf-life requirements, etc.) and regulatory issues impacting supply into appropriate risk mitigation actions
Current Employees apply HERE
Current Contingent Workers apply HERE
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:
Temporary (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
01/6/2025*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:R326353