RA Specialist CMC Dossier Development | €60K - €120K | Leiden (NL)
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 and Biotechnology organisation, based in Zuid-Holland Netherlands.
You author sections of the CMC dossier and ensure that final versions comply with regulatory requirements, and you fulfill regulatory agency expectations. You support technical specialists in the development of responses to health authority inquiries, regarding clinical trials and marketing applications. You evaluate and ensure the completeness, accuracy, and compliance of data provided for all regulatory submissions. You ensure all Quality submissions are completed in a timely manner.
2. Execute dossier strategy / product development plans with a high level of autonomy
3. Direct responsibility for project budgets
4. Leads dossier authoring activities for late stage projects for regulatory filings
5. Identifie business improvement areas and drives implementation of improvements
6. Develop process and business improvements within own organization
7. Interface with internal and external stakeholders
8. Manage projects with both standard and accelerated priority
9. Resolve cross-functional issues
10. Appropriately identifie and manage key stakeholders, and escalates when needed to obtain senior management support. Takes day-to-day decisions on operational priorities for his/her team, and allocates resources accordingly
11. Work mostly independently on a day to day basis, checks in with supervisor weekly
12. Manage functional or project teams with up to 10 members
- OR University degree with 6+ years industry experience
- Experience with Module 3 Dossier Development for premarketing IND/IMPD or MAA/BLA
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
The Company
Janssen Infectious Diseases and Vaccines (formerly Crucell) is a biotech company that focuses on the development, production and marketing of vaccines, recombinant proteins and antibodies to prevent and combat infectious and other diseases. Within Janssen talented, entrepreneurial people are working in a dynamic culture in which innovation and a ‘can do’ state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.Role Description
You develop the technical eCTD sections to support Regulatory CMC dossier applications. You coordinate and provide technical oversight for the generation of the CMC dossier for marketing and clinical trial submissions. You coordinate the timeline, virtual document, and generation of the Quality module. You assume personal ownership and accountability for business results and solutions and you represent the department on multi-functional project development teams to support regulatory filings.You author sections of the CMC dossier and ensure that final versions comply with regulatory requirements, and you fulfill regulatory agency expectations. You support technical specialists in the development of responses to health authority inquiries, regarding clinical trials and marketing applications. You evaluate and ensure the completeness, accuracy, and compliance of data provided for all regulatory submissions. You ensure all Quality submissions are completed in a timely manner.
Responsibilities
1. Support dossier strategy / product development plan creation at a compound level2. Execute dossier strategy / product development plans with a high level of autonomy
3. Direct responsibility for project budgets
4. Leads dossier authoring activities for late stage projects for regulatory filings
5. Identifie business improvement areas and drives implementation of improvements
6. Develop process and business improvements within own organization
7. Interface with internal and external stakeholders
8. Manage projects with both standard and accelerated priority
9. Resolve cross-functional issues
10. Appropriately identifie and manage key stakeholders, and escalates when needed to obtain senior management support. Takes day-to-day decisions on operational priorities for his/her team, and allocates resources accordingly
11. Work mostly independently on a day to day basis, checks in with supervisor weekly
12. Manage functional or project teams with up to 10 members
Requirements
- PhD with Post-doc experience and 3+ years of industry experience- OR University degree with 6+ years industry experience
- Experience with Module 3 Dossier Development for premarketing IND/IMPD or MAA/BLA
Other information
Full time preferred, 32 hours discussable. For Expert candidates, 20 hours is also discussable. Flexible on location, though you are expected to come to Leiden 1-2 days per week. This a long-term position.Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
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