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Project Manager (non-clinical)

Company Name:
BioBridges, LLC
Overview
Our client is a growing international specialist healthcare company who develops medical products that meet the needs of specialist healthcare physicians and their patients.
Their Clinical Divide
Need an additional resource to help the team with the workload.
Hot buttons are: Know how to use MS Project, experience with program management with Pharma/Device, scientific education desired.
Project Details
This position is responsible for the management, strategic implementation and successful completion of drug and/or device development and commercialization projects ensuring consistency and alignment with company strategy, commitments, goals and values. They will be required to manage multiple projects and/or large project teams. They will ensure all their objectives and behaviors are aligned with the company mission, vision and values.
1. Provide a focus for the day-to-day management of projects, mobilizing the team between project team meetings, building a collaborative and supportive group who makes continual progress.

2. Lead the planning and implementation of projects. Ensure the rationale and scope of the project is clarified through a Team Charter. Identify and manage project dependencies and critical path. Estimate the resources and participants needed to achieve project goals. Negotiate appropriate resource and skills allocation as required to deliver on specific projects.

3. Design and implement strategies for drug and/or device development. Ensure drug and/or device development and commercialisation activities are managed according to agreed costs, quality and timelines. To review and approve expenditure forms and invoices.

5. Monitor and report the on-going progress of the project to the designated project lead (e.g. Franchise Leader) and other key stakeholders. Resolve and/or escalate issues in a timely fashion, ensuring the designated project lead (e.g. Franchise Leader) and project team are updated on all relevant project matters (e.g. anticipated significant variances in milestone dates and project costs). Generate status reports for monthly PMRs, collating information provided by project team members, and ensuring submission within the required deadline.

6. Participate in project team meetings and ensure meeting minutes, action items and team decisions are documented. Assist the designated project lead (e.g. Franchise Leader) in creating the agenda, updating the risk logs, finalising team meeting documents and archiving these documents to a shared location. Contribute to problem-solving, decision-making and obtaining agreement within the team.
7. Ensure projects have continued business justification enabling the organisation to respond quickly to developments and ensure our investments will deliver measurable benefits, through co-ordinating the generation and maintenance of a Business Plan.

8. Co-ordinate the generation and annual update of the Project Plan for projects, collating sections completed by project team into one document. Define how a project?s time, cost, scope and quality performance targets are to be achieved by clarifying the major components, activities and resources required.

9. Run risk management process, with potential risks or threats to the success of the project being identified early and controls and mitigating actions put in place through maintenance of Risk Register and generation of Critical Risk Remediation Plans.
10. Generate and manage project budgets, ensuring that cross-functional project costs are regularly updated for tracking purposes, monitoring the expenditures against benefits delivered. Ensure that the database for accounting is up to date and accurate.

11. Develop, implement and update the MS Project gantts to plan, schedule project timelines and track performance. Reinforce deadlines, ensuring specific goals are set with realistic timeframes, prioritised and then each deliverable is tracked to ensure on-time completion.

12. Establish and maintain a Reference Manager database of project-specific and related background information and therapeutic area publications for use by the project team.

13. Conduct project post-mortems to identify lessons learned and share those lessons with project team members and other project managers through a Lessons Log. Ensure the project team continually learns from their successes and mistakes and shares this learning with the rest of the organisation.

14. Maintain relationships with vendors (e.g. CROs, CMOs) and seek best practise in outsourcing.

15. Assist in maintaining necessary project documentation to ensure compliance with Quality Management System. Ensure that project document storage processes (both electronically and hard copy) adhere to SOPs and ICH guidelines (GCP/GMP) for document storage and retention, including the appropriate use of archive storage.

16. Participate in Project Management team meetings. Contribute to discussions to develop in-house standards and procedures for project planning and management. Act as role model and mentor to associate project managers.

EDUCATION AND EXPERIENCE
1. University degree, preferably in life science subject

2. Significant experience in project management

4. Experience in a multidiscipline role (i.e. with involvement in CMC, Clinical, Regulatory Affairs and/or Commercial)
Scope
12 month contract
5 days per week onsite in office (West Conshohocken)

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