Biologics, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
We are recruiting for regulatory project managers who have a proven track record of successful submissions of new products and line extensions from Phase 0 through marketed products. As the Regulatory landscape becomes more complex, the industry has to respond with new ways to develop drugs. The Health Authorities are continually implementing new Regulations that require extensive change in our business processes.
This role involves project managing strategic projects focusing on innovation, efficiencies, compliance and business process improvement within and beyond.
d share critical elements in a concise and accurate manner in writing and through presentations.
If you would be interested in joining the team at G&L Scientific, please send your CV 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.
Job Type: Contract
Role Description: Development Regulatory Project Manager – US
Manage global projects to simplify how we conduct our business, enable compliance with the Regulations and optimize innovation. Apply knowledge in project management to independently address complex problems.
Develop, evaluate and manage business case and cost/ benefit analyses.
Drive discussions with business partners to define and deliver project scope and charter.
Define approach to project delivery and develop the associated project plans and timelines.
Lead the execution of the project and deliver projects on budget, on schedule, and with deliverables that meet or exceed customer expectations. Raise issues and drive issues to resolution. Implement and oversee risk management practices on the project.
Identify and recommend project deliverables that address the root cause of complex problems. Lead development of relevant Project Management deliverables.
Provide change management guidance to ensure sustainable transformation. Ensure Change Management best practices are incorporated throughout the project delivery.
Proactively communicate with stakeholders regarding project status, financial health, risks and mitigation of issues, and dependencies across projects.
Facilitate process improvement activities on projects using operational excellence methodologies and tools.
Manage multiple projects and prioritize workload in accordance with business goals.
Contribute to the improvement of the portfolio & organizational development function via updating deliverables, sharing knowledge and enhancing tools and techniques.
Three or more years of related experience in project management or strategic consulting in cross-functional projects is required; experience in drug development projects pharmaceutical/biotech industry is preferred; experience supporting a global team is a plus. Proficiency with common project management tools such as MS Project is required. PMP (Project Management certification) or equivalent, Change Management certification and Process certification is a plus.
Ability to foster a collaborative environment.
Excellent planning and prioritization skills with the ability to multi-task and adapt to a changing environment.
Strong communication skills in English, demonstrated ability to communicate effectively in a multifunctional and global environment.
Proven track record in driving change.
Strong analytical skills, including ability to clearly define problem statements and define new processes/deliverables to meet project objectives.
Ability to take complex ideas, processes, and requirements an
Internal Number: 1111
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.