Role DescriptionThe Technical Integrator (Senior Scientist) Dossier Development (VPAD) is responsible, with some managerial guidance, for developing the technical eCTD sections to support Regulatory CMC dossier applications. You coordinate and provide technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions. The Technical Integrator coordinates the timeline, virtual document, and generation of the Quality module. You assume personal ownership and accountability for business results and solutions, working with some managerial supervision, and represent the department on multi-functional project development teams to support regulatory filings.
The Technical Integrator authors/drives, as appropriate, sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfill regulatory agency expectations. You also support the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as marketing applications, and evaluate the completeness, accuracy, and compliance of data provided for all regulatory submissions. Finally, you ensure that all Quality submissions are completed in a timely manner.
Responsibilities- supports the creation of a dossier strategy / product development plan 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 - identify business improvement areas and drive implementation of improvements - develop process and business improvements within own functional organization, and align with other departments as needed - interface directly (with some guidance) with CMC/Tech team members, Regulatory, JSC, external service providers and internal VPAD/PDMS customers such as GCO and TA. - interface mainly internal functional stakeholders, and some external stakeholders - influence or persuade others to accept new ideas, approaches or concepts or gains alignment on divergent issues - combine technical expertise with management skills, and possibly supervise a consultant - manage a limited number of projects with standard, rather than accelerated priority, or with assistance of a Senior staff member, manages complex projects with potentially accelerated priority - challenge status quo and have ability to identify innovative approaches to improve products/processes - scope is primarily incremental innovation, within own dept / team - appropriately identify and manage key stakeholders, and escalate when needed to obtain senior management support. Take day-to-day decisions on operational priorities for his/her team, and allocate resources accordingly - manage functional or project teams with up to 10 members
Requirements- PhD with Post-doc experience with 3+ years relevant experience - OR University degree with 6+ years relevant experience
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Alexander Wielemaker.