07 sep
|
TFS HealthScience
|
Barcelona
07 sep
TFS HealthScience
Barcelona
About this role
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.
The Senior Medical Writer will be responsible for the scientific accuracy, data and referencing quality, appropriate style, and correct branding of scientific/medical assets for the client globally.
The Senior Medical Writer will work in an international and cross-functional environment, following global and local guidelines and working closely with internal and external stakeholders to ensure the highest quality for company assets and gathering data on asset quality and agency performance.
As part of our SRS/FSP team, you will be dedicated to one sponsor, a integral pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.
Key responsibilities
- Perform data/referencing quality check of scientific/medical assets; ensuring all content is scientifically accurate and appropriately supported by the Reference Documents.
- Review content and identify any non-compliances with the local regulatory guides.
- Perform some actions in the Review and Approval platform (Veeva Vault) such as reference tagging or claims object creation.
- Check anchors/links to references required to support the scientific/medical assets.
- Identify assets that may require pre-alignment with internal stakeholders.
- Flag claims that may be difficult to substantiate or do not follow regulatory/internal guidelines.
- Track asset quality data for internal and external reporting.
Qualifications
- Experienced Medical Writer or Medical Content Reviewer (3-5 years), with a scientific background and degree (PharmD, MD, PhD or Masters), at least 3 years producing or reviewing content for the Pharma/Biotech industry.
- Excellent medical writing skills.
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📌 Senior Medical Writer (Barcelona)
🏢 TFS HealthScience
📍 Barcelona