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Project Manager
Eingestellt von Elevate Direct
Gesuchte Skills: Support, Oop, Entity
Projektbeschreibung
PROJECT MANAGER - BEERSE, BELGIUM - €35 - €40 PER HOUR - 11 MONTHS
The Project Manager will:
Provide CMC (Chemical manufacturing Control) Team Support and represent PDMS 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 (Compound Development Team) strategy
Manages the CMC end-to-end process from pre-NME (New Molecular entity) through launch
Proactively plans and manages the cross-functional project deliverables that support the CMC development and Commercial Launch:
Owns the PDMS 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 PDMS 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
QUALIFICATIONS
A minimum B.S. degree. a MS, MBA, PharmD, PhD degree in a pharmaceutical-related, life sciences, or business subject.
Professional project management certification (eg, PMP)
Industry/business experience,including experience in the pharmaceutical industry.
Experience with CMC development
Experience required in areas such as manufacturing, active pharmaceutical ingredient, drug product development, CMC regulatory, analytical development,
Experience in developing a health authority dossier is a plus.
ADDITIONAL INFORMATION ABOUT THE PROCESS
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.
The Project Manager will:
Provide CMC (Chemical manufacturing Control) Team Support and represent PDMS 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 (Compound Development Team) strategy
Manages the CMC end-to-end process from pre-NME (New Molecular entity) through launch
Proactively plans and manages the cross-functional project deliverables that support the CMC development and Commercial Launch:
Owns the PDMS 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 PDMS 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
QUALIFICATIONS
A minimum B.S. degree. a MS, MBA, PharmD, PhD degree in a pharmaceutical-related, life sciences, or business subject.
Professional project management certification (eg, PMP)
Industry/business experience,including experience in the pharmaceutical industry.
Experience with CMC development
Experience required in areas such as manufacturing, active pharmaceutical ingredient, drug product development, CMC regulatory, analytical development,
Experience in developing a health authority dossier is a plus.
ADDITIONAL INFORMATION ABOUT THE PROCESS
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges