Medical Writer, Devices ( Home-Based, Europe) IQVIA MedTech
- Experience Level
- Experienced (non-manager)
IQVIA MedTech Solutions, including Genae which is a fully owned business unit of IQVIA, specializes in clinical research for Medical Devices and In-Vitro Diagnostic (IVD) products.
IQVIA MedTech’s focused expertise meets the growing needs of device Sponsors to justify product safety and effectiveness as well as reimbursement and adoption challenges due to increased scrutiny by regulators, end-users, and patients.
In this highly specialized role you will Prepare, reviews and coordinates the preparation of MedTech clinical trial and regulatory documents for either internal customers or external clients. Documents may be related to medical devices, combination products and in-vitro diagnostics (IVD) with content consistent to industry regulations and client specifications. Participates in project teams and may lead specific tasks consulting senior staff as necessary. Builds strong, lasting relationships with client teams.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Leads the preparation of all chemistry manufacturing and controls (CMC), and regulatory documents including, but not limited to, CTD Modules of initial IND, pre-IND packages, EU MPD, clinical trial applications to Health Canada, clinical trial applications in Europe in collaboration with internal teams and members of client authoring teams
- Supporting the development, implementation, and improvement of internal processes and SOPs
- Performs gap analysis of CMC packages of client’s investigational products and provides CMC strategy for the drug product development
- Reviews all regulatory/CMC documents composed by contributing and supporting writers and regulatory staff
- Responsible for providing document-specific advice to clients, offering both a consultative and regulatory writing service
- Engages with key opinion leader and client staff to understand CMC aspects of new investigational drug products in a fast-paced environment
- Interprets and breaks down data from varying sources of CMC information
- Performs other duties as assigned
KNOWLEDGE, SKILLS AND ABILITIES:
- Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.
- Demonstrated CMC knowledge, chemical or biologic products.
- Familiarity with the structural and content requirements of CMC or method validation and batch manufacturing records, and similar documents for internal and external clients.
- Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
- Competence in completing good first draft technical reports or CMC modules within a standard timeframe with limited guidance.
- Ability to give a presentation to a project team and/or customer on project-specific topics, e.g. on lessons learned.