Role : Regulatory Affairs Project Manager
Location -Bucks and Home working
The Project Manager (PM) deals with multiple small and/or complex customer needs that request to onboard different skills & different people. She or he
- Is responsible for all contractual commitments with its clients.
- Is responsible of one or more projects and lead the project team members that will bring their skills to meet the customer needs,
- Is the client interface and ensure the total client’s satisfaction
- Is accountable for the deliverable deadlines of the project(s),
- Is responsible to monitor project financial items to secure invoicing and project cost optimization.
- Capitalizes on the success stories to give best practices and ensure a continuous success of the projects the company manage,
- Will generate business opportunities thanks to the good relationship with the customer and its needs.
KEY DUTIES AND RESPONSIBILITIES:
Management of the project
Staffing of the project team
- Sets up the team of consultants (can be limited to one consultant) at the beginning of the project interfacing with Entity Directors (can be also subcontractors or partners).
- The PM is responsible of the effective allocation of the project activities
- Interfaces with leaders to staff new consultants on the project when needed, including external partners if necessary
Project team management
- Organizes internal communication with the team members (consultants, subcontractors, partners) for a good understanding of the project (Contract, deliverables, schedule, budget, good practices and invoicing rules). Organizes regular internal meetings if applicable
- Coordinates consultants’ tasks
- Cascades information from the client
- Leads handovers between consultants
- Facilitates the setup of a client induction plan for consultants if needed.
- Deals with blocking points in close collaborations with consultants but remains the decision maker for the project.
Ensure client satisfaction
- Organizes regular communication with the client (depending on project size)
- Is the key point of contact for the client, especially with top management for complex projects and strategic orientation
- Gathers, consolidates, analyses and presents the KPI requested by the client
- Prepares and holds regular meetings, steering committees with the client
- Organises, leads the final meeting with the client (and other internal or external people if applicable and needed) to gather the client’s feedback
Manages deliverable deadlines
- The PM is knowledgeable about the contract, in terms of deliverables and deadlines. Handover from Quotation Manager to PM to be performed systematically at the beginning of the project
- The PM identifies (with project team) activities to undertake, defines the project lead-time and critical path, and builds a risks analysis on the project and its lead-time
- Coordinates production (the PM delegates the responsibility of Quality Control to the related Topic Leaders/Consultants and is not necessarily an expert on the content produced)
- The PM is accountable for deliverables deadlines. Thus, the PM monitors and controls regularly the activities progress.
Financial responsibilities and Cost monitoring
- The PM monitors and is accountable of project financial items to secure project cost optimization.
- Is responsible to stay within the project budget.
- Validates or corrects the invoices dashboard updated by the “Fitnet coordinator”
- Ensure Tips & Expenses availability and support invoicing accuracy in due time
- Manage and control partner activities and invoices.
- Sends monthly reporting to the client if applicable
- Organizes annual or semi-annual or final internal meeting in order to capitalize on deliverables, method, time spent and skills with customer, team members feedback on 1) regulatory, scientific, medical knowledge, 2) missions 3) commercial proposals, 4) client knowledge, 5) PM methodology
- Capitalize on commercial documents used for prospection and commercialization.
Generates / seizes business opportunities
- Seizes business opportunities on a day-to-day basis and coordinates with the BD team (new proposals, acquisition of new projects, …)
- Participates to regular commercial meetings with the client (at least 1 meeting per year for key clients, and on a case-by-case basis for other clients) with the active participation of the Business Development lead or team member.
EDUCATION AND EXPERIENCE
- MSc or equivalent ideally post graduate qualification in a business relevant area with a minimum of 5/7 years relevant experience in pharmaceutical industry
- Proven track record of projects managed successfully in service company
- Experience in cross functional project teams
- Ability to work in a small/mid-company and in a matrix and international environment
- Experience in the Pharmaceutical industry welcome
Education and skills
- Educated in regulatory affairs, pharmaceuticals, biotechnology,…
- Fluent in English. Other languages might be an asset
- Outstanding verbal and written communication skills
- Ability to manage client, internal and external resources
- Ability to work in a matrix environment
- Self-organized, rigorous, process-oriented
- Experience (and/or mastered) in using the PM tools: Gantt, Microsoft,…
- Flexibility and agility to work in a fast-moving environment
- Hard worker, reactive, proactive, enthusiastic, agile, team spirit, committed and integrity are some of the important qualities and values is keen of.