Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
The purpose of the Global Labeling Therapeutic Areas group is to drive labeling strategy and ensure high quality and compliant labeling documents which ensure the safe and effective use of products for patients and healthcare providers, globally. The Global Labeling Therapeutic Areas group is accountable for developing and maintaining the target product labeling for developmental products, the core labeling documents (CCDS) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU and most of world labeling.
As part of Global Labeling Therapeutic Areas, and under the supervision of the Manager, Global Labeling, the Global Labeling Lead (GLL) is responsible for managing labeling of assigned products for developmental and marketed products, globally. This includes collaboration with the cross-functional labeling team to develop and maintain the CCDS and US labeling, including associated patient labeling documents, and the target product labeling. The GLL is also responsible for supporting local country affiliates on the development and maintenance of the EU and most of world labeling.
- Overall accountability for the initial creation and updates to labeling documents for assigned products including development and maintenance of CCDS, US labeling, and their associated patient labeling documents, and target product labels. Includes the responsibility to work cross-functionally and lead meetings to develop, review and approve labeling documents.
- Operates as the primary point of contact on assigned products for all internal and external stakeholders to ensure timely regulatory submissions , quality and compliant labeling documents, and to support business objectives. Includes support required for audits/inspections related to assigned products.
- Provides project management throughout the entire process, from the request to update a CCDS/US labeling through notification to stakeholders, in order to ensure documents are produced in a timely manner according to internal operating procedures and external regulatory requirements. Includes the responsibility to manage communication plans, distribution of labeling documents, updates to labeling tracking reports and databases, and providing status updates to Global Labeling management.
- Knowledgeable about key labeling requirements worldwide and ensures that country labeling documents are aligned with the CCDS or reference labeling documents.
- Provides regulatory expertise and guidance for the development and submission of US labeling components. Controls the consistency of US labeling content through alignment with the CCDS, across product families where necessary, and with all applicable best practices.
- Assists with creation/update of local product labeling (EU and most of world) for assigned products and interfaces with Regional Labeling Lead and local country affiliate colleagues to support timely and quality regulatory submissions and approvals globally.
- Supports the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.
Minimum Education Requirement
- Bachelor’s degree in a scientific or medically-related discipline required.
Required Experience and Skills
- Minimum of 6 years of pharmaceutical or relevant experience with a focus on product labeling inclusive of regulatory product labeling (CCDS, US and EU labeling) requirements for marketed products.
- Ability to develop relationships and work well with others in demanding situations with a positive attitude.
- Detail oriented, well organized, high project management skills
- Proven ability to lead effective, well-integrated, collaborative teams and drive teams to consensus and results.
- Excellent leadership, communication (verbal and writing) and collaboration skills.
- Proven ability in medical writing.
- Experience in Word, Excel and PowerPoint, and document management tools.
Preferred Experience and Skills
- Regulatory submission experience.
- Process improvement or compliance/quality experience.
- Skilled in negotiation skills. Works well with others, especially on a cross-functional team.
We are a research driven bio-pharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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