Project Manager at Rose International

Required Education and Experience Combination:
· 5+ years relevant experience with BA/BS
· 3+ years relevant experience with MA/MS/MBA
· 0+ Years relevant experience with PhD, PharmD, or equivalent

Required Experience and Knowledge:
· Where applicable, multiple years’ project management experience in life sciences, including multiple years’ experience co-managing project teams
· Where applicable, proven effectiveness in managing project teams in life sciences
· Has complete knowledge of full-cycle project management, from project start-up to close-out
· Has advanced knowledge of project management best practices and tools (SmartSheet, Timeline Pro and Visio) and has shown the ability to apply these to improve project efficiencies and effectiveness
· Has significant industry knowledge, including knowledge of drug development, and can flex own knowledge to work on molecule and/or non-molecule projects
· Independently solves problems incurred and seeks advice when needed. Ensures solutions are consistent with organizational objectives
· Ability to coach less experienced team members in resolving problems

Preferred Experience and Knowledge:
· Clin Pharm will be a plus

Development Project Manager, Clinical Pharmacology (ClinPharm) Responsibilities:
· Acts as the project manager for assigned projects of simple to moderate complexity.
· With little guidance from the Clin Pharm Project Management leader, develops and manages project plans, timelines, communications, meetings, and other interactions to ensure project deliverables are met on time, to the expected quality, and within budget.
· Typically manages multiple projects simultaneously and is expected to play a key role in ensuring cross-project synergies are realized.
· Oversee ClinPharm Subteams (CPSTs) and Protocol Concept Sheet development at the asset level, ensuring the execution of Clinical Pharmacology strategies to support program lifecycle management.
· May support the CliniPharm Submission Working Group (CSWG) by developing, coordinating and managing timelines for NDA/BLA submissions, leading cross-functional matrix teams comprising Medical Writing, Data Management, Regulatory Project Management, ClinOps, BioStats, and Clin Pharm team members.
· Manage submission-level ClinPharm deliverables and milestones aligned with submission strategies and the ClinPharm Review and Approval process. Key deliverables include QC/QA-ed PK data, PopPK data, E-R data, Pop PK reports, E-R reports, eSub packages, m2.7.1, m2.7.2, and other regulatory components.
· Oversee the ClinPharm portfolio and operations, including developing and maintaining CPPM SharePoint sites, templates, processes, and workflow diagrams.
· Leads simple to moderately complex assignments that enable multiple functions and teams to achieve their project objectives within targeted timelines and allocated resources.
· Leverages past precedence and Clin Pharm PM best practices to advise other functions on how to best achieve their project goals and objectives.
· Interacts and collaborates with other functions; key stakeholders include Clin Pharm Lead, PMx lead, BioA lead, CPPM, Clin Ops, RPM, CDM, Medical Writing, and Regulatory Affairs)
· Collaborates and partners with others across Development to ensure assigned projects are completed on time, within budget, and to the expected quality.

Key Accountabilities/Core Job Responsibilities:
· Manages task assignments and output quality of others supporting their projects.
· Provides matrix management to project teams supported. Typically manages multiple teams simultaneously.
· With support from the TA Project Management lead, creates and manages project budgets and resource plans for assigned projects.
· Support identifying cross-project synergies to leverage efficiencies and ensure consistencies where appropriate.
· Leads simple to moderately complex projects that enable Development initiatives to proceed. Errors made at this level may cause delays to achieving targeted project outcomes.
· Contributes to CPPM best practices and improvements.
· Identifies cross-project synergies that accelerate our progress and maximize efficiencies.

Benefits:

For information and details on employment benefits offered with this position, please visit here .Should you have any questions / concerns, please contact our HR Department via our secure website .

California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender(expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law.Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).