EU Labeling Lead Associate Director
Morigno Farm, Salamanca, Spain
hace 2 días

Job Description

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world.

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.

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 group is to drive the labeling strategy and ensure that labeling documents are of high quality and compliant for the safe and effective use of our products for patients and healthcare providers, globally.

As part of the Global Labeling group and under the supervision of the EU Labeling Group Lead, the EU Labeling Lead (Associate Director) is accountable for managing the labeling of developmental and marketed products registered under EU procedures (MRP / DCP / CP).

This includes partnership 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 :

  • Manages 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.
  • Ensures 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.
  • Oversees change control for EU labeling documents.
  • Oversees the labeling activities of a team of EU Labeling Lead Senior Specialists
  • Oversees the monitoring for competitor labeling updates.
  • Ensures the appropriate review and analyses of labeling guidelines and regulations to ensure conformance with EU regulations.
  • Oversees, understands, and interprets complex scientific issues as it relates to regulatory requirements and labeling strategy.
  • Proactively identifies labeling issues. Offers creative solutions and strategies, including risk mitigation strategies.
  • Participates in continuous improvement projects for EU labeling activities and business objectives. Initiates and / or implements procedures, processes, or programs to align with corporate strategies and processes.
  • Ensures 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 cross-functional team remotely located
  • Detail oriented, well organized
  • High project management skills
  • Experience in Word, Excel and PowerPoint, and document management tools.
  • Education

  • Bachelor’s degree in a scientific or medically related discipline required. Master’s degree preferred
  • Minimum of 10 years pharmaceutical or relevant experience with a focus on EU regulatory product labeling requirements for marketed and developmental products.
  • Who we are

    We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.

    Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

    What we look for

    Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity.

    You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.

    Our team is constantly evolving, so if you are among the intellectually curious, join us and start making your impact today.

    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 for the common good.

    We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

    Current Employees apply

    Current Contingent Workers apply

    Search Firm Representatives Please Read Carefully

    Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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

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