Technical Integrator (Dossier Development and Operations)

At the moment we are urgently looking for a Technical Integrator (Dossier Development and Operations).

  • Do you have a regulatory background?
  • Do you have experience with late-stage development?
  • Are you 50-100 % available?

Then you are the perfect candidate for this function! So do not hesitate to apply today to find out more!

Job Description 

The selected contractor is responsible, with some managerial guidance, for developing the technical eCTD sections to support Regulatory CMC dossier applications. With some managerial guidance, coordinates and provides technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions. Coordinates the timeline, virtual document, and generation of the Quality module. Assumes personal ownership and accountability for business results and solutions, working with some managerial supervision. Represents the department on multi-functional project development teams to support regulatory filings.

Authors/drives, as appropriate, sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfil regulatory agency expectations with some managerial guidance. Supports the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as marketing applications with some managerial guidance. Evaluates and ensures the completeness, accuracy, and compliance of data provided for all regulatory submissions with some managerial guidance. Ensures all Quality submissions are completed in a timely manner.

Responsibilities 
  • Supports dossier strategy/product development plan creation at a compound level
  • Executes dossier strategy/product development plan with a high level of autonomy
  • Direct responsibility for project budgets
  • May lead dossier authoring activities for late-stage projects for regulatory filings with some managerial support
  • Identifies business improvement areas and, under some managerial supervision, drives implementation of improvements
  • Develops process and business improvements within own functional organization, and aligns with other departments as needed
  • With some guidance, interfaces directly with CMC/Tech team members, Regulatory, JSC, external service providers and internal VPAD/PDMS customers such as GCO and TA.
  • Interfaces mainly internal functional stakeholders, some external stakeholders
  • Influences or persuades others to accept new ideas, approaches or concepts or gains alignment on divergent issues with some guidance
  • Combines technical expertise with management skills. May manage a consultant
  • Manages a limited number of projects with standard, rather than an accelerated priority, or with the assistance of a Senior staff member, manages complex projects with potentially accelerated priority
  • Challenges status quo and has the ability to identify innovative approaches to improve products/processes
  • The scope is primarily incremental innovation, within own dept/team
  • With guidance, resolves cross-functional issues
  • Appropriately identifies and manages key stakeholders, and escalates when needed to obtain senior management support. With some guidance, takes day-to-day decisions on operational priorities for his/her team, and allocates resources accordingly
  • Works mostly independently on a day to day basis, checks in with supervisor weekly
  • Manages functional or project teams with up to 10 members 
Profile 
  • PhD with Post-doc experience with 3+ years of relevant experience
  • OR University degree with 6+ years relevant experience OR Equivalent by experience
  • Regulatory background
  • Experience with late-stage development
  • Full time strongly preferred, 32 hours discussable (minimum 20 in case of exceptional seniority and expertise).
  • Longer term anticipated. Flexible on location though commitment expected to come to Leiden 1-2 days per week.
  • English required, Dutch not important. 
Contact Information 

Claire Aerts
+32 15 21 11 04
claire.aerts@valesta.com

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