Technical Integrator - Senior Scientist
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands.
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.
- 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
- 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.
The Company
The company is one of the world’s leading research-based pharmaceutical and healthcare companies.Role Description
The 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.
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