Technical Writer - Technical Integrator (Yacht Life Sciences) - 24 - 40 per week
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.
Yacht Life Sciences has a vacancy for a Technical Writer - Technical Integrator (Dossier Development and Operations) at our client Janssen Vaccines & Prevention in Leiden.
As a Technical Writer/ Technical Integrator you are 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, you will coordinate and provide technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions.
Furthermore, you will coordinate the timeline, virtual document and the generation of the Quality module. You assume personal ownership and accountability for business results and solutions working with limited supervision from the manager. You will also represent the department on multi-functional project development teams to support regulatory filings, and has expertise in appropriate CMC regulatory applications.
As a Technical Writer/ Technical Integrator, you author/drive, as appropriate, sections of the CMC dossier and evaluate/ensure that final versions comply with regulatory requirements and fulfill regulatory agency expectations with limited guidance from the manager. You support 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. Also, you will evaluate and ensure the completeness, accuracy and compliance of data provided for all regulatory submissions with limited guidance from the manager. Finally, you will ensure all Quality submissions are completed in a timely manner.
Job Scope/Span of Influence:
Contribution to dossier strategy/complex product development plan creation at a compound level and to limited degree at a functional level
Communication and execution of dossier strategy/product development plan with high level of autonomy and accountability
Direct responsibility for project budgets
Lead and supervision of dossier authoring activities for early and late stage projects with limited or no guidance from manager
Identification of business improvement areas and lead implementation of improvements
Drive structured improvements of functional processes (quality, cost, time, asset utilization) in line with business or operational strategy.
With limited or no guidance, interface directly with CMC/Tech team members, Regulatory, JSC, external service providers and internal VPAD customers
Interface with internal and external functional stakeholders
Influence 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
Combine technical expertise with management skills. May select and manage external consultants
Manage several complex projects with potentially accelerated priority OR leads complex Phase 3 clinical programs
Challenge status quo and identifies innovative approaches to improve products/processes
Scope is a mix of incremental and transformational innovation, within own dept/team and function
Appropriately identify and manage key stakeholders and escalates when needed to obtain senior management support. With limited guidance, take day-to-day decisions on operational priorities for his/her team, and allocates resources accordingly
Work independently on a day-to-day basis, checks in with supervisor as needed for identified high-priority issues
Manage functional or project teams with up to 15 members
Strong input on promotions, recruitment strategy and team structure
Act as a mentor to one or more individuals
May coach project teams
Master degree with 6+ years relevant experience in biochemistry, pharmacy or related
Extensive experience with Module 3 CMC dossier development
Experience in scientific regulatory writing in Documentum based systems.
fluency in English
Working remotely is possible
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 minimal 24 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). This role can be performed on a freelance (ZZP) base as well.
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.