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Senior Medical Writer Safety Services
hace 2 semanas
The Medical Writing Department of the GCTO organization prepares various regulated documentation. The Senior Medical Writer Safety Services role focuses on participant safety reporting, such as participant narratives, that support the clinical and regulatory writing portfolio.
The Senior Medical Writer Safety Services is responsible for developing and managing medical writing deliverables across therapeutic areas under management and Safety Services Leads' limited supervision. The Senior Medical Writer Safety Services supports the clinical development pipeline through the scientific contribution to the preparation of participant safety narratives to support CSR, module 2.7.4., SUR, RTQ, and narrative writing.
The Senior Medical Writer Safety Services delivers quality English-language documents in compliance with internal conventions and industry standards promptly and efficiently, following the department and company processes and tools.
The Senior Medical Writer Safety Services will also participate in:
- Orientation and coaching of junior team members or contractor writers
- Initiatives to improve narrative medical writing processes and standards
- Assist in the development and delivery of training material
- Data collection for document metrics as defined by the process
- Interprets and applies knowledge of regulatory/compliance/scientific requirements, drawing from prior work experience, clinical direction, and broad appreciation of the impact on other disciplines
- With minimum supervision of the Safety Services Lead and in collaboration with stakeholders across functional areas (e.g., Managing Medical Writer, BARDS, Clinical team), the Senior Medical Writer Safety Services manages narrative medical writing projects, including the design, planning, and preparation of clinical documentation that require participant narratives
- Works collaboratively with colleagues across functions to achieve results
- Team Leading responsibilities, with up to 3 reports
- Fosters the use of new technology and supports innovative approaches to writing, reviewing, and QC of the documents
**Qualifications, Skills & Experience**
The Assistant Medical Writer Safety Lead must demonstrate the following skills:
- Degree in Life Science with 5+ years of clinical trial-related experience in the pharmaceutical, medical, and/or biotech industry
- A minimum of 4 years of experience as a narrative medical writer/medical writer preparing safety documents in the pharmaceutical and/or biotech industry
- The ability to prepare participant narratives aligned with the company guidelines and international governmental regulations
- Demonstrated ability to present clinical data objectively in a clear, concise format in keeping with industry guidelines
- Experience in the preparation of clinical and regulatory documents that extends beyond narratives is preferred but not required
- Ability to work with minimum supervision
- Complete fluency in reading and writing American English
- Strong writing and editing skills following defined processes and templates
- Understanding of clinical databases and data collection tools to facilitate data exploration for reporting purposes (e.g., InFORM, MARRS, JReview, SDTM)
- Knowledge of appropriate ICH, GDPR, and EMA 0070 guidelines for reporting participant narratives
- Detailed oriented with a focus on delivering quality documents
- Experienced with systems used for collaborative authoring and document workflow (i.e., document management systems, SharePoint)
- Ability to solve problems associated with medical writing scope of work, seeking advice from management and others as needed, and exercising negotiation and communication skills with project team members
- Strong oral and written communication skills
A high degree of organization and proficiency in leading a team to achieve results
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
No relocation
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R230163
