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Project Manager Med/ Clin IV

$119k+
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Description

Project Manager IV

JOB INFORMATION

Job Profile: Project (R&D) Manager

JOB SUMMARY
As part of the Project Management Chapter, the Global Project Manager (GPM) plays a key role in optimized product delivery, accountable for all project management aspects of various projects from simple to complex in nature. Takes project/product from the original concept through completion by developing and directing detailed work plans, schedules, project estimates, spending, resource plans, and status reports. As a trusted advisor, the GPM translates and drives projects into products and enables the organization to use energy and time effectively and efficiently while quickly responding to changing business needs across the portfolio.

Responsibilities
Owns project/program/product structures for product development & product care activities including communication management, timelines, resource and budget plans, progress and cost control. Owns & drives integrated project plans including dependencies, resources and budgets allowing the teams to work efficiently and effectively. Accountable for quality implementation in complex projects in the following areas: Project risk management; Critical path analysis; Scenario creation and analysis; Budget; Robust planning.

Consistently executes complex project management processes including guiding and managing preparation for milestone reviews, capacity reviews (cQCR, SCR & fQCR), etc., as applicable & may lead improvement initiatives. Implements best practices in project/product teams and leads continuous improvement by sharing best practices and knowledge among peers.

Selects project methodology and applies agile methods as appropriate, including coaching and guiding teams in project methodology including agile practices (with Project/Program Leads or PMC management if appropriate). Expertise in working in a hybrid Agile role combining Agile methods (usually within the project/product team) with non-Agile techniques (usually needed with partners and some functions).

Leads meetings and fosters knowledge sharing between project/product teams and sub-chapters to enhance project effectiveness and optimized delivery. Establishes positive project/product team dynamics through team building.

Leads Goal Setting; establishes, measures and reports the Key Performance Indicators (KPIs), standard metrics, Objectives and Key Results (OKRs) or Outcome Based Planning (OBPs) key results for projects enabling teams and functions to measure and improve quality, efficiency and effectiveness.

Acts as a trusted advisor with a 360 view on all levels to advise and support the project/product teams as well as the broader organization in the holistic planning; project risk management; scenario creation as well as critical path analysis with the aim to ensure an optimized value delivery. Single point of contact & control for project and program data collected from the functions.

Identifies project risks and describes potential implications for budget, timeline and scope.. Identifies gaps, potential bottlenecks or delays, challenge assumptions and proposes innovative options to close gaps and get complex projects back on track while communicating issues proactively to stakeholders.

Manages complex project/product team information to support the teams themselves, the Life Cycle Teams (LCTs) and/or other governing body decision making. Frequently provides high level/pre-defined and recent planning data for scenario analysis and decision making on a portfolio level. Acts as Agile Program Manager as defined by Scaled Agile Framework (SAFe) where applicable.

Works closely with Sub-Chapter Leads, Network Leads, Functional Partners, Finance, Portfolio Management, Analytics & Insights and other chapters to ensure an optimized project delivery. Coach other members of the project/product team as well as peers in all key areas of PM expertise, develop new skills and provide ongoing, constructive feedback on performance and progress toward goals and expectations.

Leads improvement initiatives including proposals, planning, and implementation on Sub-Chapter or Chapter level.


Education Details
Bachelor's Degree science, engineering or business related field - REQUIRED
Master's Degree science, engineering or business related field - PREF


Years of Experience
REQUIRED - 6 years project management / engineering/ business experience in the diagnostic, medical device, pharmaceutical or biotech industry leading product development and product care projects.
PREFERRED - 8 years project management / engineering/ business experience in the diagnostic, medical device, pharmaceutical or biotech industry leading product development and product care projects

REQUIRED - 1 year experience in clinical biomarker or In Vitro Diagnostic development
PREFERRED - 3 years experience in clinical biomarker or In Vitro Diagnostic development.

REQUIRED - 1 year experience in companion diagnostic development, analytical and clinical validations and regulatory submissions or instrument development and program management.
PREFERRED - 3 years experience in companion diagnostic development, analytical and clinical validations and regulatory submissions or instrument development and program management.

REQUIRED - 1 year years experience in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001)
PREFERRED - 3 years years experience in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001)

Knowledge, Skills and Abilities:
Profound problem solving & conflict management skills and ability to coordinate project related activities.
Strong stakeholder management and facilitation skills.
Proficient in Portfolio & Project Management Tool.
Ability to manage complex projects with ambitious milestones.

Ability to escalate and drive management decisions in relation to project execution and resource needs.
Good strategic and tactical thinking.
Profound analytical thinking.
Profound in transferring knowledge cross projects, programs or LCTs. Profound understanding of relevant Design Control and/or Phased Development processes.
Good knowledge in healthcare quality and risk and regulatory compliance.
Value delivery mindset.


Licenses and Certifications
PREFERRED - PMP Project Management Professional
PREFERRED - Other: Agile Methodologies X

Last updated on Oct 20, 2023

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