Management Assistant

il y a 2 semaines

Bruxelles, Région de Bruxelles, Belgique Oxford Global Resources Temps plein

Management Assistant (Clinical Operations):

  • Location:
Brussels, Belgium

  • Contact:
Aurore Munaut

  • Job type:
Contract

  • Contact phone:
  • Industry:
Pharmaceutical

Our pharma client is looking to reinforce the their team in view of EC/CA submissions. Do you like administration and do you have experience with EC and CA submissions ? Additionally, you are fluent in English, Dutch and French ? Then this may be for you


The management assistant is responsible for the provision of secretarial, administrative and organizational assistance to the Clinical Development & Operations team.


The tasks need to be performed within the defined timelines and in accordance with ICH-GCP and/or other ethical and regulatory requirements and Boehringer Ingelheim procedural documents.


The management assistant will have an additional role and will most of the time be allocated to the submission bureau and be responsible for EC/CA submissions under the EU Directive 2001/20/EC.

The management assistant reports to the Clinical Trial Assistant Team Leader.

Responsibilities

EC/CA submissions under EU Directive 2001/20/EC:

  • In time and high quality compilation and submission to CA/EC of amendments. Follow-up of the submission with the concerned bodies in order to obtain the approval
  • Coordinate all requests/questions from the relevant bodies in order to formulate a high quality and in time answer
  • In time and high quality notification to CA/EC of End of Trial
  • In time and high quality submission to CA/EC of the Clinical Trial Report
  • Updating the CTA database
Secretarial and organizational assistance to the Clinical Development & Operations department:

  • Preparation, organization, support and attendance of meetings and write meeting minutes when applicable.
  • Travel and meeting arrangements. Lunch reservations.
  • Logistic support eg ordering office supplies, business cards, mail distribution lists.
  • Manage departmental trackers.
  • Assist in onboarding/off boarding process.

Document Management:

  • Management of internal & external paper archiving

Operational:

  • Assist in insurance certification
  • Coordinate/assist translation of documents
  • Support in vendor management (equipment)
  • Assist in contract management and related processes
  • Payment and invoice management
  • Support in Health Care Compliance processes

Requirements:

  • In depth knowledge of regulations about EC/CA submissions
  • Preferably 23 years experience in EC/CA submissions
  • Effective time management, adherence to given deadlines
  • Good organization and structure
  • Teamwork
  • Good communication skills internally and externally
  • Proactive working style
  • Results oriented
  • Accurate (attention to detail)
  • Ability and willingness to work in a highly regulated and performancemonitored environment
  • Degree/education: Administrative qualification or equivalent by experience
  • Relevant language skills: Fluent in written and spoken English, Dutch and French
  • Existing right to work in Europe required

Benefits

  • Balanced salary package
  • Hybrid model
  • Vacancy number: 21954

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