Reg Affairs Manager; Documentation
vor 1 Woche
Responsibilities:
- Solve any technical document or workflow concerns when suitable on the documents being processed.
- Work with internationally located in NIBR scientific staff to guarantee finalisation of the documents rendering to timelines and quality needs.
- You will advice writers, newcomers and vendors on SDV needs, technical formatting procedures ad the use of the company's document management systems.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in a scientific field or relevant work experience.
- Fluency in the English language.
- Communication skills both verbally and in writing.
- Pertinent familiarity working with electronic document management systems and document evaluation.
- Comprehension of clinical and nonclinical information contained in a proposal dossier.
- Able to work successfully within a matrix setting and influence crossfunctional teams.
- A flexible individual with a high attention to detail.
- Familiarity with as well as comprehension of compliance practices, which involves GxPs and SOPs.
- Customer service outlook.
- Computer literacy in MS Office.
- A selfstarter with the capacity to prioritise workload.
- Capable of working on various tasks simultaneously as well as manage time efficiently within a fastpaced setting.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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Regulatory
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