Senior Medical Writer (with German)

About TFS HealthScience

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.

About the role

The Medical Writer / Technical reviewer will be responsible for the scientific accuracy, data and referencing quality, appropriate style, and correct branding of scientific/medical assets for the sponsor globally. Also 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 the sponsor assets and gathering data on asset quality and agency performance.

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 German

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 a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.

Department *SRS South Europe* Locations Barcelona, Madrid Remote status Fully Remote Employment type Full-time REQ ID reqID301829 Work Arragement Remote