Business Project Lead
Vacancy number • PUB406677
department is responsible for the entire regulatory IT systems and data management,
publishing of registration, dossiers maintenance and archiving, management of the related
labeling and artwork for the AH product portfolio and project management of initiatives that
impact the regulatory and artwork management processes.
About this role
The GRA Operations Business Project Lead is responsible for project management of a global initiative with a compliance and regulatory driver. This initiative is cross departmental requiring strong communication and leadership skills with internal and external stakeholders. The GRA Operations Business Project Lead is responsible for managing projects in the global work stream with a focus on systems and representing the systems stream in related streams (Process stream and change management and implementation stream) within the global regulatory alignment initiative. Ensure, onboarding of local affiliates to the Regulatory Information management platform.
Main tasks will cover different projects within the Regulatory system stream:
- Managing different projects in the system stream in the Global Regulatory alignment initiative.
- Responsible for leading and setting up team meetings, communication, management meetings, alignment with other project streams.
- Planning, tracking, and informing stream leads on progress.
- Ensuring achievement of milestones within the set timelines.
- Creating overall awareness and ensuring engagement and expectations of stakeholders.
- Alignment focuses on local and global systems and processes.
- Close collaboration with different streams within the Global initiative and stakeholders (R&D IT, Global Regulatory Affairs, local affiliates).
- Setting business requirements.
- Conduct User Acceptance tests (UATs).
- Create and maintain training materials. Provide training, presentations, and communication on relevant systems use and alignment when business processes vary.
- Responsible for resource planning.
- Transition tasks to the business after completion of project.
- MSc degree is required or BSc with proven related working experience.
- 5 to 10 years experience in project management.
- 10+ years work experience within the pharmaceutical industry preferably in Regulatory Affairs.
- Good understanding of the regulatory processes.
- High affinity with IT systems and data management.
- Experience with GMP systems within the pharmaceutical industry.
- Strong communication skills.
- Team Player.
- Fluent English (speaking, reading and writing).
- Strategic thinking, commercial awareness, results driven.
- Proven leadership and influencing skills.
- Accurate and efficient.
- Enthusiastic, energetic and with positive mindset.
Brunel offers outstanding individuals a highly diverse and challenging job in a company where an open, professional and pleasant working culture is highly valued; where your personal initiatives are noticed and rewarded; and where you get all the support, coaching and training you need for your future career. This is your chance to discover a wide range of sectors and activities and develop your expertise in a fast-paced and results-driven environment.
Being brokered by Brunel means you have a contract with Brunel. Not only do you have a contract, you are guaranteed a great career! Our primary and secondary terms of employment are excellent. Some examples are price reductions with CZ health insurance, bonus opportunities and standard 26 days off. Brunel Engineering has been mediating both junior and senior engineers within the industry for over 30 years. Our clients range from multinationals to local companies. Together, we find the job that meets your needs.
Brunel is a specialized staffing agency, which means you are the focus! We always look for assignments that match your ambitions, life stage, and knowledge. Our consultants maintain warm and personal contact with you as a specialist and are always there for you.
With over 45 years of experience, we know better than anyone how to support and empower people to grow and excel in their careers. Our passion for people drives us to work every day with full conviction on our mission to make a difference in the development of our people.
Brunel's core values, "Passion for people," "Entrepreneurship," "Honest and integral," and "Results-oriented," guide our organization and the way our employees act. These values contribute to a positive and productive work environment.
Diversity and inclusion
Additionally, Brunel is committed to valuing and encouraging the diverse cultures, backgrounds, and perspectives within our company. We believe in the power of differences and think that diversity and inclusion contribute to a creative and innovative organization.
CSR (Corporate Social Responsibility)
At Brunel, we are strongly aware that we have a responsibility to operate not only economically but also socially and ecologically sustainably. This allows us to grow responsibly and contribute to a better world for future generations. We hope to make an inspiring impact on other companies and collectively make a meaningful difference for people and the environment.
We believe in creating an environment where you can realize your potential and contribute to the success of Brunel. This means connecting, learning, and developing. Here are some benefits of working at Brunel:
- Thanks to our onboarding program, you start with confidence right away.
- The personal development plan provides insight into your ambitions and opportunities within Brunel, offering you the chance to achieve personal goals.
- Through our BeSmart platform, you can take various in-house training courses.
- The training budget allows you to attend courses and training that align with your development needs and ambitions.
- The communities provide a platform where you can network and collaborate with other professionals.
We are here to help achieving your ambitions.
Do you also dream of becoming the best in your profession? Or do you aspire that one dream job? Let us support you! Our Be Smart online learning environment offers all you need. Trainings, study materials and best practices, aimed to improve both your hard and soft skills.
Part of our program is to let you learn and share experiences with colleagues; a network of fellow specialists who participate in training sessions, events, webinars and socials. The ideal platform to spar about your ideas and get to know each other.
Along with our network come many experiences to support your personal, customized career path. Brunel colleagues are assigned in over 500 companies in various branches, that enable you to explore your potential and realize your ambitions.
Any questions remaining?
Your consultant, Lisette Koopman is happy to clarify anything about this vacancy. When reaching out, use the pub number: PUB406677