Duties and Responsibilities:
- Write and/or review final Clinical Study Report(s) in compliance with the internal SOPs and the guidance of different regulatory authorities (TPD, FDA, EMA, etc.).
- Assist in the development of document templates, relevant Standard Operating Procedures (SOPs) and guidelines.
Work closely with clinical personnel and the Principal Investigator to ensure that clinical documents are produced to the standard required by Good Clinical Practice (GCP).
- Ensure accurate and complete documentation of all clinic study source documents and/or forms according to company’s SOP, GCP and other applicable guidelines.
- Conduct all work in compliance with SOP’s, GCP and to observe all regulatory guidelines.
- Negotiate timelines with external departments.
- Compile study documents, as required.
- Photocopy and scan study documents.
- Perform other work as assigned.
- Minimum university degree, B.Sc. (i.e. Life Sciences)
- At least 2 years of Medical Writing experience
- Experience in an CRO environment, preferably in the conduct of Phase I and Bioequivalence studies
- Good interpersonal and communication skills
- Attentive to details, good initiative and able to work with changing priorities
Job Type: Full-time
- CRO environment - preferrably conducting Phase I & BE study: 1 year (Preferred)
- Medical writing: 2 years (Preferred)
- Bachelor's Degree (Preferred)