DirecciónJob Description
EU Labeling Senior Specialist
The purpose of Global Labelling is to drive labelling strategy and ensure high quality and compliant labelling documents which ensures the safe and effective use of products for patients and healthcare providers, globally.
As part of Global Labelling, and under the supervision of the EU Labelling Lead, the EU Labelling Senior Specialist is responsible for the labelling of developmental and marketed products registered under EU procedures (MRP / DCP / CP).
This includes collaboration with the cross-functional labelling team to develop and maintain the EU Product Information (including all its Annexes as defined by EU legislation).
Responsibilities of the EU Labelling Sr Specialist may include, but are not limited to :
- Proofs, edits, and manages labelling documents.
- Updates designated databases / internal sites containing department information according to standard operating procedures (SOPs).
- Monitors mailboxes and handles inquiries, as appropriate.
- Uses experience and knowledge to create and update labelling and labelling documentation.
- Participates in programs for continuous improvements of labelling 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 Labelling team, the Regulatory Affairs Europe Liaison and internal stakeholders.
- Works cross functionally to ensure timely regulatory submissions, high quality and compliant EU labelling documents and to support business objectives.
- Interacts with key business partners
Skills
- EU labelling experience in oncology, vaccines or other therapeutic areas and relevant industry experience 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 organised, 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.
Education
- Bachelor’s degree in a scientific or medically-related discipline required. Master’s degree preferred.
- Minimum of 4 years of pharmaceutical experience or relevant professional experience.
