Reg Affairs Manager; Documentation

vor 2 Monaten

Basel, Schweiz Proclinical Vollzeit

Proclinical are recruiting a Reg Affairs Manager; Documentation for a pharmaceutical organisation. This role is on a contract basis and is located in Basel. The client is focused on providing remedies that help improve and extend the lives of many.

**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 cross-functional 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 self-starter with the capacity to prioritise workload.
- Capable of working on various tasks simultaneously as well as manage time efficiently within a fast-paced setting.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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