Senior Project Manager - Life Science (m/w/d)
Posted on May 5, 2020 by ITech Consult
Senior Project Manager - Life Science (m/w/d) - Life Science/PTR/Roche/Bio-tech/6 Sigma
For our customer Hoffman La Roche in Basel we are looking for a highly qualified Senior Project Manager
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.
Tasks & 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 life cycle (ie 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.
* Demonstrates, or has proven abilities to demonstrate PTR and Roche 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.
* 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.
Nice to haves:
* Project Management certification
PLEASE NOTE: ASK FOR FULL DESCRIPTON VIA E-MAIL!
Reference No.: 919313SGR
Role: Senior Project Manager