Field: Life Cycle - Biopharmaceutical Drug Development Services
Contract: Permanent
We are looking for a Medical Writing Assistant/Officer Junior W/M to join our team.
(1/2 days on site)
Responsibilities
Coordination of documentation related to regulatory and clinical development.
Check document preparation such as protocols, clinical summaries, QC that tabulating listing is working, ICS, clinical documentation; Module 1 preparation may be included.
Knowledge of CTD.
Example of tasks:
Document management with quality control and eCTD ready.
Formatting deliverables in relation to the medical writer responsible.
Manage the publication of study report appendices or contact the CRO responsible for the publication to provide necessary documents and ensure the quality of the publication.
Conversion of documents to PDF in eCTD ready format.
Organization of internal proofreading channels for these documents and the signature channel in connection with the medical writer in charge.
Estimated/simulated travel costs.
Help with document formatting and presentation preparation (PowerPoint).
Organization of scientific and technical meetings, team (room, invitations, equipment).
Specialty: Drug Therapeutic area: Oncology
Profile
Minimum 3 years of experience excluding periods of internship and alternance.
Extensive knowledge of the scientific and medical environment in oncology.
Medical and scientific writing technique.
Analytical and synthesis skills.
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