Vacancy Senior Manager CMC-RA

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Municipality
Leiden
Education
HBO
Hours per week
40 hours
Contract type
Tijdelijk met uitzicht op vast
Salary indication
€4000-7000
Vacancy number
#1AV0022444

About the job

About the job

External Job Description

Main tasks (will be performed under supervision of permanent CMC-RA staff).
1. CMC-RA support for preparation of variation packages, renewals, new MAA (non-ICH), and response documents Concerns both EU and non-EU (i.e. EMEA region) submissions. Concerns both CTD module 3 (and QOS) and Normative Document for small molecules
2. CMC-RA support for preparation of baseline submissions
3. Contribute to the assessment / comparison of updated ICH/non-ICH file as part of a global compliance project
4. Creating overviews of available quality modules in order to prepare for migration to another document management system
5. Contribute to the compliance check of CMC-RA information in the applicable systems

What we offer

  • Fulltime job (40 hours)
  • Great Salary (4000-7000)
  • One year contract

Job requirements

Requirements:

  • Experience (at least 3 years) with CMC-RA related preparations for variation packages, renewals, new MAA (non-ICH), and response documents. Preferably, also experience with Normative Document preparations /updates.
  • Having experience with IT systems (like Trackwise, document management systems), Excel, Word
  • Strong organizational skills
  • Accurate
  • Being able to work independently
  • Good communication skills.
  • Able to read and speak in English
  • Full time available
  • You live in the Netherlands

About the company

Be ‘On the Forefront of Healthcare Change to turn innovative science into value for patients’ is their long term corporate vision for continued success. In order to realize this, they must constantly challenge themselves, be open to change and work together. It is an innovative and successful organization because of diverse and talented people who respect each other and who value the power of long-term relationships. They believe that it is important to create a positive working environment and to inspire employees to develop their talents. They want their employees to achieve full professional potential as they engage closely with the company, furthering its success and growth, and reinforcing its contribution to society.

The company is based in Leiden. It's easy to reach with the car and they have free parking. Also you can go with the public transport from Leiden, Den Haag, Rotterdam and Amsterdam (Schiphol).

Job information

Unique Uitzendbureau Leiden

Schipholweg 55
2316 ZL Leiden

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