Senior Medical Writer (Portuguese speaker)
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 global 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.
- Strong attention to detail and accuracy, ability to manage and prioritize multiple, detailed activities, results-orientated with fast and focused execution.
- Good communication, coordination and time management skills.
- Fluent in oral and written English AND Portuguese.
- Ability to work within a team or across multiple teams (including remotely) as well as independently.
- Values teamwork and collaboration, diversity and inclusion, and innovation.
- Prior experience working in content creation for Biotech/Pharma, would be advantageous.
- Prior experience working in any of the therapeutic areas: Metabolism, Cardiovascular Diseases, Chronic Kidney Disease, Respiratory, Inflammation; would be advantageous
- Prior experience with the Pharmaceutical Content Review process and/or Veeva Vault would be advantageous
What We Offer
We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.
A Bit More About Us
Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
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 global 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.
- Strong attention to detail and accuracy, ability to manage and prioritize multiple, detailed activities, results-orientated with fast and focused execution.
- Good communication, coordination and time management skills.
- Fluent in oral and written English AND Portuguese.
- Ability to work within a team or across multiple teams (including remotely) as well as independently.
- Values teamwork and collaboration, diversity and inclusion, and innovation.
- Prior experience working in content creation for Biotech/Pharma, would be advantageous.
- Prior experience working in any of the therapeutic areas: Metabolism, Cardiovascular Diseases, Chronic Kidney Disease, Respiratory, Inflammation; would be advantageous
- Prior experience with the Pharmaceutical Content Review process and/or Veeva Vault would be advantageous
What We Offer
We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.
A Bit More About Us
Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.