Medical Writer/Scientist

Location Leiden
Discipline: Biotechnology, Pharmaceutical
Job type: Temporary/Freelance
Contact name: Selin Ozbeden

Contact email:
Job ref: 15463
Published: about 1 month ago

For a leading Biotech company I'm looking for a Medical Writer/ Scientist with good technical writing skills. 

• Authoring and/or reviewing technical transfer reports
• Authoring and/or reviewing validation reports
• Assist on authoring BLA filing documentation and drafting answers for questions from health authorities, support during Pre-Approval inspection (PAI)
• Supports RSV-F process lead in her activities and back-up in her absence

• Good technical writing skills and command of MS Word and MS Excel. Fully trained for TruVault
• Understanding of GMP documentation
• Able to retrieve and assess data from production systems (MBR, PI, DeltaV, eLIMS, etc…); perform gap assessments and communicate to SME’s
• Working knowledge of organization and R&R; able to communicate effectively with other business units and departments
• Assertive and able to visualize an action plan towards task completion, identifying and escalating roadblocks on time
• Experience on inspections/audits is a plus
• Supervisory skills are a plus

If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme?
For more information please contact Selin Ozbeden on     +31 (0)20 20 44 502