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Project Manager

Job Description

Project Manager
Oceanside, CA


 GENERAL POSITION SUMMARY
The Product Project Manager Position is dedicated to supporting Technical Regulatory Teams (TRTs) in managing programs efficiently and effectively and in executing regulatory activities. This role will be involved in all aspects of TRT operations, while maintaining a tight linkage to the PTR Project and Portfolio Management Group (PPM).  The Product Project Manager is an advocate of PPM, utilizing best practice methodologies to support TRTs and portfolio managers in providing clear communications for assessment and trending of the PTR portfolio. This role builds effective relationships with Technical Regulatory Leads (TRLs), TRT Members, Technical Development Teams, Technical Product Teams, PPM and other program stakeholder to ensure visibility to TRT operations and cross-functional alignment of TRT strategy.
JOB DESCRIPTION – primary duties and responsibilities
Support TRTs and TRLs in developing TRT charters, plans, detailed schedules, deliverables lists, status updates, resource requests and program specific communications for individual programs in the regulatory product portfolio including large molecules, small molecules, devices, antibody drug conjugates.   Be a thought partner to TRLs and team members, facilitate and drive team discussions based on high-level program knowledge.
Provide project management support to TRTs at any stage of the drug development lifecycle (i.e. early or late stage development, marketing authorization or post-launch marketed phases).  Provide support of PTR Strategic Focus Areas and cross-organizational initiatives
Coordinate and facilitate TRT meetings and all aspects of program information management ensuring robust documentation and communications.
Partner with TRLs and teams, facilitating team interactions and mobilizing teams to deliver successfully on the agreed objectives.
Execute project management activities to support products for global market applications and product life-cycle activities.
Support issue-specific multi-product impacting regulatory projects to ensure alignment of regulatory strategy and compliance across the Biologics and Small Molecule platforms.
Ensure regular and meaningful project communications, including dashboards, reports and metrics, to enable timely information and analyses to key stakeholders and decision makers.
Ensure product information flows between TRT members to ensure transparency, informed decision making, and optimal alignment of all technical regulatory deliverables.
Maintain linkage between TRT and TDT or TPT ensuring alignment of assumptions and communications at all times.
Facilitate regulatory program risk assessment and align with TPM and TDT processes. Develop, execute and report on risk mitigation or issue resolution activities.
Proactively monitor timelines, submission process KPIs, critical path and resources for assigned products using appropriate tools, project management principles and practices. Monitor timeline deviations from baseline and KPIs and closely collaborate with TRLs and Submissions Leads to keep submissions on track.  Assist with driving data compliance and accuracy across the organization.
Provide support to PPM and PTR management on major departmental and cross-functional initiatives including Strategic Focus Areas (SFAs).
Leverage and continuously improve PPM business processes and program management methodologies.
Develop and maintain the PPM resource library (templates, tools etc.) and improve it based on use and feedback by the TRTs.
Collaborate with Regulatory Operations and colleagues in PTR and PDR for regulatory submissions as needed.
Train and onboard peers and TRT members in the principles of Project Management and standardized  processes for TRT operations.
 
 
Other Skills/Competencies
Demonstrates, or has proven abilities to demonstrate PTR and Core Competencies.
Strong influencing, organizational and interpersonal skills; consistently achieves targeted results without authority and by leveraging his/her expertise, business knowledge, and relationships.
Strong partnering skills; has exceptionally strong and highly effective working relationships with internal and/or external customers and stakeholders.
Understands key change management concepts and methodologies.
Must work well as member of a diverse global team and in a proactive, positive and collaborative manner; Ability to manage cross-functional teams.
Outstanding project management, planning, organization, prioritization and time management skills. Can effectively and efficiently manage and complete multiple, large-scale and complex priorities and projects on-time and on-target.
Able to deal with ambiguity and constant change.
Able to work independently with minimal supervision.
Able to function effectively and in an agile manner in a fast-paced, multi-tasking environment.
High level knowledge of regulatory requirements, manufacturing or technical development processes.
Highly Competent in MS office applications including Excel, PowerPoint, Word, Project and Smartsheet or other PM tools.
 
QUALIFICATIONS
Education & Experience
BA/BS or MS in Scientific, Technical, Engineering or Business discipline. Advanced degree preferred.
A minimum of 8-10 years' total work experience with at least 5 or more years' relevant experience in project management within the pharmaceutical/biotech/medical device industry with a sound knowledge of drug development processes.
Project, Program, or Portfolio Management certification is preferred but not required. Knowledge of Project Management methodologies, concepts, techniques and tools is required.
Prior experience with programs and portfolios in a strategic context is a plus.
Prior regulatory experience preferred.
Six Sigma or other OE-related certifications a plus.
 
 
TRAVEL REQUIREMENTS
Ability to travel up to 20%

Department:
Operations Functs: Regulatory CMC & Info Systems

Job Category:
Project Management

Hours Per Week:
40.00

Is this contractor working in a GMP environment?:
Yes

Job Requirements

 

Job Snapshot

Location US-CA-Oceanside
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Clinical & Scientific, Energy, Oil & Gas
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Company Overview

Ascent

The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Learn More

Contact Information

US-CA-Oceanside
Gurmeet Singh
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Snapshot
Ascent
Company:
US-CA-Oceanside
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Clinical & Scientific, Energy, Oil & Gas
Store Type:

Job Description

Project Manager
Oceanside, CA


 GENERAL POSITION SUMMARY
The Product Project Manager Position is dedicated to supporting Technical Regulatory Teams (TRTs) in managing programs efficiently and effectively and in executing regulatory activities. This role will be involved in all aspects of TRT operations, while maintaining a tight linkage to the PTR Project and Portfolio Management Group (PPM).  The Product Project Manager is an advocate of PPM, utilizing best practice methodologies to support TRTs and portfolio managers in providing clear communications for assessment and trending of the PTR portfolio. This role builds effective relationships with Technical Regulatory Leads (TRLs), TRT Members, Technical Development Teams, Technical Product Teams, PPM and other program stakeholder to ensure visibility to TRT operations and cross-functional alignment of TRT strategy.
JOB DESCRIPTION – primary duties and responsibilities
Support TRTs and TRLs in developing TRT charters, plans, detailed schedules, deliverables lists, status updates, resource requests and program specific communications for individual programs in the regulatory product portfolio including large molecules, small molecules, devices, antibody drug conjugates.   Be a thought partner to TRLs and team members, facilitate and drive team discussions based on high-level program knowledge.
Provide project management support to TRTs at any stage of the drug development lifecycle (i.e. early or late stage development, marketing authorization or post-launch marketed phases).  Provide support of PTR Strategic Focus Areas and cross-organizational initiatives
Coordinate and facilitate TRT meetings and all aspects of program information management ensuring robust documentation and communications.
Partner with TRLs and teams, facilitating team interactions and mobilizing teams to deliver successfully on the agreed objectives.
Execute project management activities to support products for global market applications and product life-cycle activities.
Support issue-specific multi-product impacting regulatory projects to ensure alignment of regulatory strategy and compliance across the Biologics and Small Molecule platforms.
Ensure regular and meaningful project communications, including dashboards, reports and metrics, to enable timely information and analyses to key stakeholders and decision makers.
Ensure product information flows between TRT members to ensure transparency, informed decision making, and optimal alignment of all technical regulatory deliverables.
Maintain linkage between TRT and TDT or TPT ensuring alignment of assumptions and communications at all times.
Facilitate regulatory program risk assessment and align with TPM and TDT processes. Develop, execute and report on risk mitigation or issue resolution activities.
Proactively monitor timelines, submission process KPIs, critical path and resources for assigned products using appropriate tools, project management principles and practices. Monitor timeline deviations from baseline and KPIs and closely collaborate with TRLs and Submissions Leads to keep submissions on track.  Assist with driving data compliance and accuracy across the organization.
Provide support to PPM and PTR management on major departmental and cross-functional initiatives including Strategic Focus Areas (SFAs).
Leverage and continuously improve PPM business processes and program management methodologies.
Develop and maintain the PPM resource library (templates, tools etc.) and improve it based on use and feedback by the TRTs.
Collaborate with Regulatory Operations and colleagues in PTR and PDR for regulatory submissions as needed.
Train and onboard peers and TRT members in the principles of Project Management and standardized  processes for TRT operations.
 
 
Other Skills/Competencies
Demonstrates, or has proven abilities to demonstrate PTR and Core Competencies.
Strong influencing, organizational and interpersonal skills; consistently achieves targeted results without authority and by leveraging his/her expertise, business knowledge, and relationships.
Strong partnering skills; has exceptionally strong and highly effective working relationships with internal and/or external customers and stakeholders.
Understands key change management concepts and methodologies.
Must work well as member of a diverse global team and in a proactive, positive and collaborative manner; Ability to manage cross-functional teams.
Outstanding project management, planning, organization, prioritization and time management skills. Can effectively and efficiently manage and complete multiple, large-scale and complex priorities and projects on-time and on-target.
Able to deal with ambiguity and constant change.
Able to work independently with minimal supervision.
Able to function effectively and in an agile manner in a fast-paced, multi-tasking environment.
High level knowledge of regulatory requirements, manufacturing or technical development processes.
Highly Competent in MS office applications including Excel, PowerPoint, Word, Project and Smartsheet or other PM tools.
 
QUALIFICATIONS
Education & Experience
BA/BS or MS in Scientific, Technical, Engineering or Business discipline. Advanced degree preferred.
A minimum of 8-10 years' total work experience with at least 5 or more years' relevant experience in project management within the pharmaceutical/biotech/medical device industry with a sound knowledge of drug development processes.
Project, Program, or Portfolio Management certification is preferred but not required. Knowledge of Project Management methodologies, concepts, techniques and tools is required.
Prior experience with programs and portfolios in a strategic context is a plus.
Prior regulatory experience preferred.
Six Sigma or other OE-related certifications a plus.
 
 
TRAVEL REQUIREMENTS
Ability to travel up to 20%

Department:
Operations Functs: Regulatory CMC & Info Systems

Job Category:
Project Management

Hours Per Week:
40.00

Is this contractor working in a GMP environment?:
Yes

Job Requirements

 
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