ProPosition Management Search - Corporate Senior Medical Writer - R&D - Remote Working and Milano, Italy
Our client is a public listed international pharmaceutical group dedicated to R&D, manufacturing and marketing of drugs in the field of: primary care, specialty care and rare diseases. The group has operations worldwide.
The Corporate Medical Writer will support the company across the full life cycle of drug development, interacting with project teams to support the creation and development of critical documents such as protocols, investigators brochures, informed consent forms, as well as other dossier related documentation (briefing books, CSRs), with support from other functions.
As the primary responsible person for medical writing within the R&D department, you will be part of a dynamic team managing Clinical Operations for the company globally.
- Independent preparation, editing and compilation of various clinical documents for regulatory submission during all phases of clinical drug development and post-marketing studies. - Clinical Study Protocols and Reports, Patient Safety Narratives, Patient Lay Summaries, investigator brochures, patient consent forms, dossier related documentation (such as Clinical summaries, Briefing Books, PDCO submissions), with support from other functions
- The Corporate Medical Writer should be specialized in clinical trial disclosure and transparency, and will redact clinical documents in accordance with EU Clinical Trial Regulation, EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), CRS (UK), and other global regulations - Responsible for the compilation and publication of trial data in relevant registries with support from relevant Medical Director
- The Corporate Medical Writer will be detailed-oriented, with critical review of complex documents, content review, data review, assurance of consistency within and across various documents. He/She will ensure controlled and accurate use of medical and scientific terminology, and is also familiar with the available bibliographic sources - Leading of different medical writing projects; project/document management, including participation in cross-functional global team meetings - Collaborate with Study Managers, Project Leaders, Clinical Trial Application Manager, Regulatory development lead, Biostatistics, Patent and Legal, to ensure awareness of data sharing requests and proper safeguarding of the data in collaboration with the company DPO where applicable - Liase with Project Teams irrespective of global location
- BA/BS or MA/MS in scientific or medical field
- Minimum of 4-5 years medical writing experience in consulting or CRO/pharma
- Experience in preparing clinical trial documentation (protocols, IBs, ICFs)
- Experience in lay summary preparation/clinical study report redaction requirements
- Experience in preparation of regulatory dossiers (Clinical Summary/Clinical Overview)
- Experience managing clinical trial registries and disclosure information
- Exceptional written and oral communication skills
- Fluent in English
Location: Remote Working and Milano, Italy
To Apply: please email a copy of your covering letter and CV to: firstname.lastname@example.org