Job Description
EU Labeling Lead Associate Director
Job Description
General Summary
The purpose of Global Labeling is to drive labeling strategy and ensure high quality and compliant labeling documents which ensures the safe and effective use of products for patients and healthcare providers, globally. As part of Global Labeling, and under the supervision of the EU Labeling Group Lead, the EU Labeling Lead Associate Director is responsible for managing the labeling of developmental and marketed products registered under EU procedures (MRP/DCP/CP). This includes collaboration with the cross-functional labeling team to develop and maintain the EU Product Information (including all its Annexes as defined by EU legislation). Responsibilities of the EU Labeling Lead Associate Director may include, but are not limited to: Manage the updates of the English EU PI (SmPC, Annex II, labeling, package leaflet and other applicable annexes) in collaboration with the Regulatory Affairs Europe team. Ensure that the EU PI adheres to regulatory template/format of EU PI and provides subject matter expertise on associated guidelines and guidance documents including Quality Review of Documents (QRD), in line with industry best practices. Oversee change control for EU labeling documents. Oversee the labeling activities of a team of EU Labeling Lead Senior Specialists. Oversee the monitoring for competitor labeling updates. Ensure the appropriate review and analyses of labeling guidelines and regulations to ensure conformance with EU regulations. Oversee, understand, and interpret complex scientific issues as it relates to regulatory requirements and labeling strategy. Proactively identify labeling issues. Offer creative solutions and strategies, including risk mitigation strategies. Participate in continuous improvement projects for EU labeling activities and business objectives. Initiate and/or implement procedures, processes, or programs to align with corporate strategies and processes. Ensure adequate support in compliance initiatives. Skills Highly experienced knowledge and understanding of the scientific principles of the drug development process. Specialized knowledge of regulations pertaining to drug product labeling. Experience in Oncology. Good oral and written communication and presentation skills. Process improvement or compliance/quality experience. Good negotiation skills. Ability to develop relationships and work well with others even in demanding situations with a positive attitude. Ability to interact with a cross-functional team remotely located. Detail oriented, well organized. High project management skills. Experience in Word, Excel, PowerPoint, and document management tools. Education Bachelor’s degree in a scientific or medically related discipline required. Master’s degree preferred. Extensive pharmaceutical or relevant experience with a focus on EU regulatory product labeling requirements for marketed and developmental products. 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Closing date for applications: 16/02/2025 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:
Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements:
Remote Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date:
02/17/2025 *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.
#J-18808-Ljbffr
Job Description
General Summary
The purpose of Global Labeling is to drive labeling strategy and ensure high quality and compliant labeling documents which ensures the safe and effective use of products for patients and healthcare providers, globally. As part of Global Labeling, and under the supervision of the EU Labeling Group Lead, the EU Labeling Lead Associate Director is responsible for managing the labeling of developmental and marketed products registered under EU procedures (MRP/DCP/CP). This includes collaboration with the cross-functional labeling team to develop and maintain the EU Product Information (including all its Annexes as defined by EU legislation). Responsibilities of the EU Labeling Lead Associate Director may include, but are not limited to: Manage the updates of the English EU PI (SmPC, Annex II, labeling, package leaflet and other applicable annexes) in collaboration with the Regulatory Affairs Europe team. Ensure that the EU PI adheres to regulatory template/format of EU PI and provides subject matter expertise on associated guidelines and guidance documents including Quality Review of Documents (QRD), in line with industry best practices. Oversee change control for EU labeling documents. Oversee the labeling activities of a team of EU Labeling Lead Senior Specialists. Oversee the monitoring for competitor labeling updates. Ensure the appropriate review and analyses of labeling guidelines and regulations to ensure conformance with EU regulations. Oversee, understand, and interpret complex scientific issues as it relates to regulatory requirements and labeling strategy. Proactively identify labeling issues. Offer creative solutions and strategies, including risk mitigation strategies. Participate in continuous improvement projects for EU labeling activities and business objectives. Initiate and/or implement procedures, processes, or programs to align with corporate strategies and processes. Ensure adequate support in compliance initiatives. Skills Highly experienced knowledge and understanding of the scientific principles of the drug development process. Specialized knowledge of regulations pertaining to drug product labeling. Experience in Oncology. Good oral and written communication and presentation skills. Process improvement or compliance/quality experience. Good negotiation skills. Ability to develop relationships and work well with others even in demanding situations with a positive attitude. Ability to interact with a cross-functional team remotely located. Detail oriented, well organized. High project management skills. Experience in Word, Excel, PowerPoint, and document management tools. Education Bachelor’s degree in a scientific or medically related discipline required. Master’s degree preferred. Extensive pharmaceutical or relevant experience with a focus on EU regulatory product labeling requirements for marketed and developmental products. 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Closing date for applications: 16/02/2025 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:
Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements:
Remote Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date:
02/17/2025 *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.
#J-18808-Ljbffr
