As Technical Integrator Dossier Development and Operations, you are responsible for developing the technical eCTD sections to support Regulatory CMC dossier applications. You will co-ordinate and provide technical oversight for the generation of the CMC dossier of marketing and clinical trial ...
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, <STRONG>Janssen Vaccines & Prevention</STRONG>, we are searching for a Technical Integrator Dossier Development and Operations.
Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.
As Technical Integrator Dossier Development and Operations, you are responsible for developing the technical eCTD sections to support Regulatory CMC dossier applications. You will co-ordinate and provide technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions. You will co-ordinate the timeline, virtual document, and generation of the Quality module.
Additionally, you will author/drive sections of the CMC dossier and evaluate/ensure that final versions comply with regulatory requirements and fulfil regulatory agency expectations. You will support the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as marketing applications. Finally, you will evaluates and ensure the completeness, accuracy, and compliance of data provided for all regulatory submissions and ensure all Quality submissions are completed in a timely manner.
- Support dossier strategy / product development plan creation at a compound level;
- Execute dossier strategy / product development plan with a high level of autonomy;
- Direct responsibility for project budgets;
- Lead dossier authoring activities for late stage projects for regulatory filings
- Identify business improvement areas and drive implementation of improvements;
- Develop process and business improvements within own functional organisation, and align with other departments as needed;
- Interface directly with CMC/Tech team members, Regulatory, JSC, external service providers and internal VPAD/PDMS customers such as GCO and TA;
- Influence or persuade others to accept new ideas, approaches or concepts or gain alignment on divergent issues with some guidance;
- Appropriately identify and manage key stake holders, and escalate when needed to obtain senior management support. With some guidance, take day-to-day decisions on operational priorities for your team, and allocate resources accordingly;
- Manage functional or project teams with up to 10 members.
Who we're looking for
We are looking for a candidate with an MSc or PhD. in Pharmacy, Biomedical Sciences or Life Sciences with relevant working experience within the (bio) pharmaceutical industry. Your scientific & regulatory writing skills to write the proper documentation are good and you have experience with working with document management systems. We are looking for someone with experience with Module 3 Dossier Development for pre marketing INDs/IMPDs or MAA/BLA and a regulatory background. You have affinity with GMP and biotechnology/pharmaceutical processes and analytical methods.
Because of the nature of the position you must have excellent interpersonal, communication and team collaboration skills.
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Project for at least 6 months, longer term anticipated. Full time strongly preferred, 32 hours discussable. Flexible on location,though commitment expected to come to Leiden 1-2 days per week.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555
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