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EU Labeling Senior Specialist

Employer
MSD
Location
Europe
Salary
Competitive
Start date
8 Dec 2021
Closing date
7 Jan 2022

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Discipline
Regulatory Affairs, Labelling
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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 Opportunity

The purpose of the Global Labeling team is to drive the labeling strategy and to 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 Lead, the EU Labeling Senior Specialist is accountable for 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 Senior Specialist may include, but are not limited to:

  • Proofs, edits, and manages labeling documents.
  • Updates designated databases/internal sites containing department information according to standard operating procedures (SOPs).
  • Monitors mailboxes and handles inquiries, as appropriate.
  • Creates and updates labeling and labeling documentation.
  • Participates in programs for continuous improvements of labeling activities and business requirements.
  • Supports Corrective and Preventative Actions (CAPAs).
  • Stays apprised of EU regulations.
  • Initial decision making, under guidance.
  • Owns decisions related to editorial changes.
  • Works internally with the Regional Labeling team, the Regulatory Affairs Europe Liaison and internal stakeholders.
  • Works cross functionally to ensure timely regulatory submissions, high quality and compliant EU labeling documents and to support business objectives.
  • Interacts with key business partners

The Candidate

  • EU labeling knowledge in oncology or vaccines or other relevant industry knowledge related to developing regulatory documentation.
  • Regulatory submission experience.
  • Knowledgeable about the scientific principles of the drug development process.
  • Process improvement and compliance/quality experience.
  • Ability to develop relationships and work well with others in demanding situations with a positive attitude.
  • Excellent attention to detail, well organized, high project management skills.
  • Experience facilitating meetings and driving consensus and results.
  • Good leadership, communication (verbal and writing).
  • Proven ability in medical/technical writing.
  • Effective critical thinking and problem-solving skills
  • Experience in Word, Excel and PowerPoint, and document management tools.
  • Bachelor’s degree in a scientific or medically-related discipline.  Master’s degree preferred.
  • Minimum of 4 years of pharmaceutical experience or relevant professional experience.

We are committed to Flexible Working, and whatever role you are in there will be options to balance your needs and the needs of the business. This could be a hybrid way of working with some time on site and some remotely or flexibility around the hours you work each day. Of course in some parts of the business, certain roles do require a fully on-site presence, whilst others can be performed entirely remotely. Please speak to us during your application process to discuss further.

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. 

Company

Imagine getting up in the morning for a job as important as helping 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 other like-minded colleagues to pursue and bring hope to countless people who are battling the most challenging diseases of our time. Our team is always evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Company info
Website
Telephone
+44-0208-1548000
Location
2 Pancras Square
London
N1C 4AG
GB

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