Lead Medical Writer
Proclinical is currently seeking a Lead Medical Writer for a fully integrated specialty biopharmaceutical company. The Zurich based role is a great opportunity to develop your medical portfolio at a global organisation.
- Author and prepare clinical study and regulatory documents including clinical study protocols, clinical study protocol amendments, clinical study reports, investigator's brochures, and sections of regulatory submissions.
- Assist with the authoring of other more complex scientific documents such as abstracts and publications. Provide basic medical writing support for documents produced by other departments
- Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents and ensure consistency between related documents.
- Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables.
- Manage outsourcing providers.
- Perform Quality Control (QC) review of documents or parts of documents prepared by other staff.
- Be responsible to implement and update / improve policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs), as required.
Skills and Requirements
- Excellent Standard of written English, and ability to communicate fluently and effectively in English.
- Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel, Powerpoint in addition to technical software required for the specific function (Adobe, Sharepoint and document management systems)
- Required to lead, participate and make positive contribution to team meetings.
- Good knowledge and understanding of ICH-GCP. Will participate in internal and external audits as well as regulatory inspections.
- Expected to build team spirit, be tolerant and considerate, be an active and open communicator and share knowledge and experience with other team members.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Terence Au at 02038618605 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.