R&D Project Manager


Vrouw in labo

Over deze funtie

  • Markt: Life Sciences
  • Branche: Pharmacie
  • Expertisegebied: Wetgeving
  • Standplaats: Vlaams-Brabant

Wat is vereist?

  • Uren per week: 40
  • Opleidingsniveau: Academic Master
  • Sluitingsdatum: donderdag 21 oktober 2021

Over deze functie

Over deze functie

We are looking for a R&D - CMC Project Manager for a project in Beerse.Experience within the pharmaceutical industry & expert in R&D or CMC?

Read on and apply now!

The CMC Project Manager will:

  • Provide 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:
  • o Works in close collaboration with the CMC Leader, SI’s, JSC New Product Team(NPT) and Commercial Lead
  • o Active follow-up on the progression of all CMC activities required to successfully launch product
  • o 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 ensure organizational readiness to support project execution (talent, training, etc.)
  • Work with line management to address gaps in current cross-departmental processes and organizational structures
    Primary Duties
    Program and Strategic Planning Operations Management and Leadership Product development & Submission Management and Oversight aligned to customers Program Information/Communication Management Program Timeline, Resource, and Cost Management Additional requirements may be identified specific for the level of CMC Leader/PML hired and/or for specific deployment considerations

Over jou

Over jou

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.

Wat wij je bieden

Wat wij je bieden

Our network and expertise make it possible for us to advance your career. Brunel has a reputation of working with some of the best in the business. That's what we continually strive for. Over 40 years, we've created a global network of interesting clients and talented individuals working together through a vast array of services.

Start je sollicitatie hier!

Start je sollicitatie hier!

Solliciteren bij Brunel gaat snel en gemakkelijk. Wij ontvangen graag het volgende van jou:

  • Recent CV of LinkedIn-profiel
  • Motivatiebrief (optioneel)
  • Certificaten (optioneel)
  • Referenties (optioneel)

Vragen over de vacature?

Jouw Talent Hunter, Katrien Daneel licht graag alles toe over deze vacature. Wanneer je contact opneemt, verwijs naar het volgende vacaturenummer:

Talent Hunter

Katrien Daneel
Brunel Belgium Mechelen

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