The Product Portfolio Management Office (Product PMO) provides PTR with services in product portfolio management, product project management, TRT program management and knowledge management. The PMO works closely with the Biologics and Small Molecule platforms to deliver a holistic strategic plan for the Biologics and Small Molecules projects portfolio and to identify common regulatory and operational themes and trends between products and projects. The Product PMO collaborates with all functions in PTR to increase efficiencies, productivity and/or quality of the way the Technical Regulatory Teams (TRTs) operate. The Product PMO portfolio management supports product project prioritization; enables the product portfolio resourcing and budgeting processes and facilitates PTR product portfolio reviews. The Product PMO Portfolio Manager will actively contribute to these services. She/he will be responsible of the PTR Product Portfolio (Biologics and/or Small Molecules) and will be responsible to continuously improve processes that the Product PMO uses to resource, oversee, and report on projects at both the project and portfolio levels. As a member of the Product PMO, he/she will drive continuous improvement of the TRT program infrastructure and the collaborations with external partners such as Pharma Technical Development (PTD), Pharma Technical Supply (PTS), Pharma Development Regulatory (PDR), etc. The Product PMO Portfolio Manager will support the knowledge management efforts in PTR by adhering to processes and fostering behaviors to ensure that critical regulatory information is consistently and easily available to PTR users.
The Product Portfolio Manager will be in contact with leaders in key partner organizations regarding TRT and TRL interactions, roles and responsibilities and deliverables. This role will build effective relationships with Technical Regulatory Leads (TRLs), Technical Regulatory Team (TRT) Members, PTR Operations Business Excellence, and other portfolio stakeholders and consumers of technical regulatory program and portfolio data.
JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:
Product Portfolio Management (Biologics and/or Small Molecules) – Develop/Adapt existing processes to accomplish the following:
Collect product project specific information from TRLs, TRTs, and technical managers including.
Technical Regulatory Strategies
Regulatory product health and project execution performance information (adherence to schedule, scope / strategy, resources)
Product and projects risks
Aggregate and analyze project data to identify, analyze, and manage portfolio-level trends and generate recommendations to PTR strategy including portfolio/business risk mitigation, staffing levels, workforce skills development, process improvements, cross-platform opportunities, etc. Develop and publish portfolio reports.
Collaborate with senior management and other stakeholders to identify portfolio data needed for decision making at various governance bodies and levels of functional leadership.
Work closely with the platforms to deliver a holistic strategic plan for their projects portfolio and to identify common regulatory and operational themes and trends between products and projects.
Establish governance and/or organization to manage the product portfolio process. Organize and/or manage the Product Portfolio Reviews. Enable the product portfolio resourcing and budgeting processes.
Develop, implement, monitor and evolve regulatory program management tools, methodologies and processes.
Drive continuous improvement of the TRT program infrastructure and of collaborations with external partners such as PTD, PTS, PDR, etc.
Support the knowledge management efforts in PTR by adhering to processes and fostering behaviors to ensure that critical regulatory information is consistently and easily available to PTR users.
Education & Experience:
MS or Ph.D. in a technical field with 10 years in the biotech industry, including 5+ years proven experience leading and or managing teams in a matrix environment.
Sound knowledge of drug development processes. Well-versed in technical lifecycle of small molecules and biologics, and familiarity with technical regulatory requirements and planning of regulatory strategy.
Previous technical regulatory experience a plus.
Previous people management experience a plus.
Demonstrates, or has proven abilities to demonstrate PTR and Company Core Competencies.
Demonstrates, or has proven abilities to demonstrate Company Values and Leadership Competencies.
Strong project management and communication skills.
Evidence of effective skills in people and team development.
Highly competent in MS office applications including Excel, Powerpoint, Word, Project, etc.
Strong influencing skills; consistently achieves targeted results without authority and by leveraging his/her expertise, business knowledge, interpersonal skills, organizational savvy and relationships.
Strong partnering skills; has exceptionally strong and highly effective working relationships with internal and/or external customers, partners and stakeholders.
Excellent interpersonal and organizational skills, including understanding of key change management concepts and methodologies; Proven abilities to effectively lead, organize and prioritize work.
Must work well as member of a diverse global team and in a proactive, positive and collaborative manner; Ability to lead cross-functional teams.
Comfort around all levels of staff and management; maintains a confident stance, stays focused and on-point, and is able to raise problems or challenges in a productive and competent manner.
Exceptional skills in assessing, summarizing and presenting business or operational priorities and decision-points for effective, timely and efficient management/executive decision-making.
Strategic orientation. Can effectively look out several years and project business or operational implications, trends, risks, uncertainties and/or opportunities.
Able to deal with ambiguity and constant change.
Able to work independently with minimal supervision.
Able to function effectively in a fast-paced, multi-tasking environment.
International or global business experience and cultural awareness preferred.
Ability to travel up to 20%
If you would like to hear more, please send your details to talent @ gandlscientific.com today!
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.
Internal Number: 1005
About G&L Scientific Inc
G&L Scientific provides consulting, staff augmentation, outsourcing and support services for Clinical Research and Regulatory Affairs. With our own teams of experts based in our offices across Europe, Asia-Pacific and the US, as well as a pool of more than 2,500 global consultants, the key to G&L’s success is a straightforward, transparent approach; experience of unrivalled depth; and the recruitment and development of brilliant people. Indeed, the level of repeat business and ongoing long-term assignments is testament to the quality of service G&L provides.
Whether our client needs an individual RA professional or full project team, onsite or remote, G&L will design a custom solution that delivers significant savings and flexibility in line with operational demands.
As well as excellence in our chosen fields, we are renowned for the quality of our people. Our real success lies in recruiting and developing brilliant consultants. We seek the right individuals to match our business needs, then build the environment that allows them to fulfill their potential. People join G&L Scientific for a variety of reasons. Some want to work with the very latest developments in Clinical Res...earch & Regulatory Affairs, others want the opportunity to make a real difference working in a dynamic and pioneering team. Ultimately, G&L people are free-thinking, proactive and creative individuals who are not afraid of change.