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Belgium Keyrus Life Science

Global Compliance Project Manager

Job Description

  • Creation / Update of RACI matrix based on material types (promo vs educational – reactive vs proactive …)
  • Creation of guidance: how to co-create material between internal stakeholders – which department layer oversees which material type (Global to Local material flow)
  • Coordinate structure of core claims
  • Lead set-up of a risk-based review approach
  • Document E2E process how to localize Abbreviated Product Information in Europe
  • Writing / Update SOPs & related flowchart
  • Scientific background  Knowledge in medical compliance (Efpia code, Directive 2001/83/EC, IFPMA Code…)

Profile

  • Ability to work with different cultures.

  • Solid communication skills.

  • Experience in project management.

  • Quick learner.

  • Manage tasks requiring details-oriented abilities with rigor and proactive dynamism.

  • Intuitive sense of prioritization and of discernment.

  • Excellent command of English (writing and speaking) and communicate with impact.

  • In the daily work, ability to manage a project alone as well as collaborating productively with.

What we offer

You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues.

Who we are

Keyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

Keyrus Belgium Offices:

  • Office Park Waterloo - Drève Richelle 161 - 1410 Waterloo
  • Nijverheidslaan 3, - Strombeek-Bever

Category

Medical Affairs

Location

Bruxelles

Contact person

SJ Janati