LABELING SPECIALIST

BrusselIFarmaceutische industrie

Functieomschrijving

For one of our pharma clients in Brussels we're looking for a EU LABELING SPECIALIST.

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 Lead, you will be responsible for 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 include, but are not limited to:

  • • Proof, edit, and manage labeling documents
  • • Update designated databases/internal sites containing department information according to standard operating procedures (SOP's)
  • • Monitor mailboxes and handle inquiries, as appropriate
  • • Use experience and knowledge to create and update labeling and labeling documentation
  • • Participate in programs for continuous improvements of labeling activities and business requirements
  • • Support Corrective and Preventative Actions (CAPA's)
  • • Stay apprised of EU regulations
  • • Initial decision making (with guidance)
  • • Own decisions related to editorial changes
  • • Work internally with the Regional Labeling team, the Regulatory Affairs Europe Liaison and internal stakeholders
  • • Work cross functionally to ensure timely regulatory submissions, high quality and compliant EU labeling documents and to support business objectives
  • • Interact with key business partners
Profiel

As LABELING SPECIALIST your profile matches the following description:

  • Master's degree in a scientific or medically-related discipline required
  • Minimum of 4 years of pharmaceutical experience or relevant professional experience
  • EU labeling experience in oncology or vaccines or other 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 organized, high project management skills
  • Experience facilitating meetings and driving consensus and results
  • Good leadership
  • Proficient in English
  • Proven ability in medical/technical writing
  • Effective critical thinking and problem-solving skills
  • Experience in Word, Excel and PowerPoint, and document management tools
  • For now, this position will be home based. Once the covid19 restrictions have been loosened, you are available for some travels to Brussels.
Organisatie- en afdelingomschrijving

Select Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis. Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.

Aanbod

You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible. We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.

Heb je nog vragen?
Marlies Collart Human capital developer Select Projects +32 3 203 50 80
LABELING SPECIALIST Vacature informatie
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