Associate Director Dossier Development
For our client, Janssen Vaccines & Prevention, we are looking for an Associate Director Dossier Development.
As Associate Director Dossier Development, you are responsible for developing the technical eCTD sections to support Regulatory CMC dossier applications.
Your responsibilities are:
- Co-ordinate and provide technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions;
- Co-ordinate the timeline, virtual document and the generation of the Quality module;
- Assume personal ownership and accountability for business results and solutions working with limited supervision from the manager;
- Represent the department on multifunctional project development teams to support regulatory filings;
- Author/drive, as appropriate, sections of the CMC dossier and evaluate/ensure that final versions comply with regulatory requirements and fulfil regulatory agency expectations;
- Support the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as major applications;
- Evaluate and ensure the completeness, accuracy and compliance of data provided for all regulatory submissions;
- Ensure all Quality submissions are completed in a timely manner.
Who we're looking for
The ideal candidate has an M.Sc. or Ph.D. with at least 8 or 6 years of relevant experience. We are looking for someone with extensive experience with Module 3 CMC dossier development as a main activity. Additionally, experience in scientific regulatory writing in Documentum based systems is also required. Excellent communication skills are also key for this position.
Janssen Vaccines & Prevention B.V. is part of Johnson & Johnson, one of the biggest and most respected health care companies in the world. They are dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacturing, and marketing of novel vaccines to prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern, such as Ebola and COVID-19.
In this organisation, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. They are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen. The offices of Janssen Vaccines & Prevention are located in Leiden, The Netherlands.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Salary: >5600|
Days of leave: 25 + 11
See here our other employment terms for this vacancy
Project till end 2022, 24-40 hours/week
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.