Senior R&D Project Manager

Highly Competitive
  1. Contract
  2. Project/Study Manager (CSM/CPM)
  3. Belgium
Beerse, Belgium
Posting date: 19 Feb 2020
27995

A worldwide and renowned pharmaceutical company is currently hiring a Senior R&D Project Manager in their Belgium office. The organisation works across a range of industries, from medical devices to pharmaceutical and consumer goods, and operates in over 60 countries. This position offers an exciting opportunity to work with a prestigious and historic pharmaceutical establishment and provide real regulatory expertise.

Job Responsibilities:

  • Providing CMC Team Support and represent CMC PM at the PMT Team.
  • Translates the CMC strategy into realistic and executable CMC deliverables with clear assumptions based on CMC & commercial input.
  • Supports risk management process, specifically identification and development of mitigation strategies with CMC team & PMT.
  • Works out scenarios to support decision making in line with CMC, JSC and CDT strategy.
  • Manages the CMC end-to-end process from pre-NME through launch.
  • Proactively plans and manages the cross-functional project deliverables that support the CMC development and Commercial Launch:
    • Works in close collaboration with the CMC Leader, SIs, JSC New Product Team (NPT) and Commercial Lead o Active follow-up on the progression of all CMC activities required to successfully launch product.
    • Monitors CMC driven key milestones, decision points and critical path activities.
  • Owns the CMC schedule in V6, including creation, monitoring and maintenance from pre-NME through launch.
  • Resource (FTE & OOP) & Budget Management in close partnership with Functional Planning and Program Coordinators.
  • Represent CMC and JSC at the PMT.
  • Works in close collaboration with the CDT Program Management Leader (CDT-PML) to ensure alignment of the CMC strategy with the CDT strategy.
  • Works in close collaboration with the PMT Program Managers to ensure alignment of functional strategies with the CMC strategy.
  • Proactively identifies areas of need within the department and works to mitigate them.
  • Identify, develop and implement best practices related to CMC, PMT and NPT Teams.
  • Proactively outline new processes and supports the integration of enabling technologies into the team setting to drive efficiency.
  • Help ensuring organisational readiness to support project execution (talent, training, etc.).
  • Work with line management to address gaps in current cross-departmental processes and organisational structures.

Skills and Requirements:

  • A minimum B.S. degree. a MS, MBA, PharmD, PhD degree in a pharmaceutical-related, life sciences, or business subject expert greater than 10 years relevant work experience.
  • Professional project management certification (eg, PMP) or degree is a plus.
  • 8-10 years of industry/business experience, including at least 4-6 years in the pharmaceutical industry.
  • Experience with CMC development and is a must.
  • Experience required in areas such as manufacturing, active pharmaceutical ingredient, drug product development, CMC regulatory, analytical development, etc.
  • A working knowledge of drug development is required.
  • Experience in developing a health authority dossier is a plus.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Anna Bigiotti on +44 2038542470 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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