Document Specialist Regualatory Affairs

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  • Aanbod Max. € 65,000
  • Functiegroep Quality & Safety, Engineering
  • Dienstverband Fulltime
  • Vacaturenummer 9177200
  • Locatie Boxmeer
  • Contract Detachering via YER
  • Branche Medical & Health

Over deze vacature

Do you have experience within the Pharmaceutical industry and documentation? If so, read further because we are looking for a Document Specialist within Regulatory Affairs. Your primary task will be the migration of documents to a new system (Alexx).

Functie

Alexx is an Animal Health Global Document Management System used to store Regulatory relevant documents across R&D. This system is run within the Veeva Vault Platform (cloud-based software).

  • Alexx Migration;
    o Migrate and reclassify documents both paper and electronic originals (Protocols, Reports, Raw Data, Literature Articles, CMC Documents, Batch Release Documents, Detailed and Critical Summaries, Sponsor Reports, etc.);
    o Migration of documents can include external regulatory related documents from SharePoint sites, network shares (i.e. shared drives) and electronic media;
    o Scan (if needed) and classify documents to be made viewable in Alexx;
    o Reclassify already existing metadata on documents in Alexx from temporary storage to the production environment;
  • This will satisfy the requirements according to VICH GCP, FDA, EPA and OECD GLP regulations and guidelines.

Major activities and responsibilities:

  • Review and identify documents for classification into the appropriate business function areas (Bio R&D, Clinical, Preclinical, Formulations and Analytical, Regulatory, CMC, Statistics, Drug Discovery, etc.) using the appropriate metadata;
  • Request new study numbers, new products, project codes, or CRO names through the Alexx portal, when necessary;
  • Contact the appropriate business function personnel to obtain information to correctly identify documents;
  • Assure close working relationship with stakeholders within R&D;
  • Review documents for clarity and completeness prior to sending for approval;
  • Will assist with other Veeva Vault tasks as the project progresses;
  • Other duties as assigned by the Global Archivist.

The Document Migration Specialist will report to the Global Archivist who is based in Madison, N.J.

  • This position is vital to the overall outcome of this project. This position is required in assuring MAH research remains within all compliance regulations and standards in regard to document control.
  • Ensure document integrity throughout the process with accurate classification of metadata.

Bedrijf

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, they are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Their ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, they strive to create an environment of mutual respect, encouragement and teamwork. As part of their global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Aanbod

You will be employed by YER and seconded to our client.

Our professionals are the key to our clients’ success. We demonstrate our commitment to our professionals by offering:

  • Good employee benefits (e.g. work-life balance, pension, travel allowance/lease car)
  • Personal guidance from your consultant customized to your preference
  • Provide development opportunities and career advice
  • Intensive support for international candidates (including Dutch lessons, tax-return and accommodation assistance)
  • A community/network of with other YER professionals from a variety of multinationals
  • Events and masterclasses with interesting speakers and attractive companies

Profiel

  • Bachelor’s degree (or equivalent work experience) with 7 years’ experience in a related field and/or industry experience;
  • Experience with at least one of the following areas: FDA GxP, GCP, EPA and OECD GLP regulations and guidelines;
  • Must have strong communication, organization and writing skills;
  • Demonstrated ability to work independently and as part of a team with strong attention to detail/accuracy and perform in a multi-task environment;
  • Demonstrated ability to focus and drive consistency;
  • Affinity with scientific R&D documents within the Animal Health or Life Science industry is required;
  • Expertise in Document Management Systems (Veeva Vault) and/or repositories like SharePoint would be preferred;
  • Expertise in Office related software (Microsoft Excel, Acrobat, etc.);
  • Ability to apply strategic and analytical thinking to a project.
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