Yacht Life Sciences has a vacancy for an Associate Director - Technical Integrator ((Dossier Development and Operations)) at our client Janssen Vaccines & Prevention in Leiden.
The Associate Director/ Technical Integrator is responsible, with limited guidance from the manager, for developing the technical eCTD sections to support Regulatory CMC dossier applications. With limited guidance from the manager, coordinates and provides technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions. Coordinates the timeline, virtual document and the generation of the Quality module. Assumes personal ownership and accountability for business results and solutions working with limited supervision from the manager. Represents the department on multi-functional project development teams to support regulatory filings. Has expertise in appropriate CMC regulatory applications.
Authors/drives, as appropriate, sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfill regulatory agency expectations with limited guidance from the manager. The Associate Director supports the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as major applications with limited guidance from the manager. Evaluates and ensures the completeness, accuracy and compliance of data provided for all regulatory submissions with limited guidance from the manager. Ensures all Quality submissions are completed in a timely manner.
Job Scope/Span of Influence:
1. Contributes to dossier strategy/complex product development plan creation at a compound level and to limited degree at a functional level
2. Communicates and executes dossier strategy/product development plan with high level of autonomy and accountability
3. Direct responsibility for project budgets
4. Leads and supervises dossier authoring activities for early and late stage projects with limited or no guidance from manager
5. Identifies business improvement areas and leads implementation of improvements
6. Drives structured improvements of functional processes (quality, cost, time, asset utilization) in line with business or operational strategy.
7. With limited or no guidance, interfaces directly with CMC/Tech team members, Regulatory, JSC, external service providers and internal VPAD customers
8. Interfaces with internal and external functional stakeholders
9. Influences or persuades others to accept new ideas, approaches or concepts or gains alignment on divergent issues with limited guidance and occasionally at multiple levels of management
10. Combines technical expertise with management skills. May select and manage external consultants
11. Manages several complex projects with potentially accelerated priority OR leads complex Phase 3 clinical programs
12. Challenges status quo and identifies innovative approaches to improve products/processes
13. Scope is a mix of incremental and transformational innovation, within own dept/team and function
14. Independently resolves isolated cross-functional issues
15. Appropriately identifies and manages key stakeholders and escalates when needed to obtain senior management support. With limited guidance, takes day-to-day decisions on operational priorities for his/her team, and allocates resources accordingly
16. Works independently on a day-to-day basis, checks in with supervisor as needed for identified high-priority issues
17. Manages functional or project teams with up to 15 members
18. Strong input on promotions, recruitment strategy and team structure
19. Acts as a mentor to one or more individuals
20. May coach project teams
PhD with Post-doc experience with 6+ years relevant experience in biochemistry, pharmacy or related
- or Master degree with 8+ years relevant experience
- or equivalent by experience
- Extensive experience with Module 3 CMC dossier development as a main activity.
- Experience in scientific regulatory writing in Documentum based systems.
- Excellent communication skills, fluent in English
Terms of employment:
We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. This concerns a full-time secondment contract for 1 year (extension is anticipated) for 24 - 40 hours a week.
We will offer a competitive benefit package in line with the seniority of the position (salary between 5500 and 7700 euro gross per 4 weeks).
You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and to become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers, you will be able to follow courses and training via our Yacht Academy in order to keep your knowledge and skills up-to-date, i.e. boosting your career through personal and scientific growth.
Information about the company:
Janssen Vaccines & Prevention, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacture and marketing of vaccines to protect people worldwide from infectious diseases.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.