Senior Medical Writer (with Italian)

TFS HealthScience; Oviedo; Presencial; EUR 40.000 - 65.000; Jornada completa

Descripción de la vacante

An international CRO is seeking a skilled Medical Writer / Technical Reviewer to ensure scientific accuracy of medical assets globally. The role demands collaboration across teams while adhering to regulatory guidelines, requiring expertise in writing, referencing, and time management. Ideal candidates possess a scientific degree and experience in biotech/pharma content creation.

Servicios

Competitive compensation

Comprehensive benefits

Growth opportunities

Formación

• 3-5 years experience as a Medical Writer or Reviewer.
• Proven medical writing skills with high attention to detail.
• Fluent in English and Italian, both oral and written.

Responsabilidades

• Perform data and referencing quality checks of medical assets.
• Review compliance with local regulatory guidelines.
• Utilize Veeva Vault for reference tagging and claims creation.

Conocimientos

Medical Writing

Attention to Detail

Communication

Time Management

Coordination

Educación

PharmD, MD, PhD, or Masters

Herramientas

Veeva Vault

Descripción del empleo

About TFS HealthScience

TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. Our expertise includes full service capabilities, resourcing, and functional service (FSP) solutions.

About The Role

The Medical Writer / Technical Reviewer will ensure the scientific accuracy, data quality, referencing, style, and branding of scientific/medical assets for the sponsor globally. The role involves working in an international, cross-functional environment, adhering to global and local guidelines, and collaborating with internal and external stakeholders to maintain asset quality and monitor agency performance.

Key Responsibilities

1. Perform data and referencing quality checks of scientific/medical assets, ensuring content accuracy and proper support by Reference Documents.
2. Review content for compliance with local regulatory guidelines.
3. Utilize the Review and Approval platform (Veeva Vault) for reference tagging and claims object creation.
4. Verify anchors/links to references supporting the assets.
5. Identify assets requiring pre-alignment with internal stakeholders.
6. Flag claims that are difficult to substantiate or do not follow regulatory/internal guidelines.
7. Track asset quality data for reporting purposes.

Qualifications

• 3-5 years of experience as a Medical Writer or Medical Content Reviewer, with a scientific degree (PharmD, MD, PhD, or Masters).
• Proven medical writing skills with high attention to detail.
• Ability to manage multiple activities efficiently.
• Strong communication, coordination, and time management skills.
• Fluent in English and Italian, both oral and written.
• Ability to work independently and in teams, valuing collaboration and diversity.
• Experience in biotech/pharma content creation and familiarity with therapeutic areas like Metabolism, Cardiovascular, Chronic Kidney Disease, Respiratory, or Inflammation is advantageous.
• Experience with Pharmaceutical Content Review process and Veeva Vault is advantageous.

What We Offer

Competitive compensation, comprehensive benefits, and growth opportunities in a rewarding environment. Join a team that values collaboration, innovation, and making a difference in patients' lives.

About Us

Founded over 27 years ago in Lund, Sweden, TFS HealthScience is a full-service, global CRO with over 800 professionals across more than 40 countries. We specialize in clinical research services across therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values are Trust, Quality, Passion, Flexibility, and Sustainability, guiding our decision-making and fostering a culture of respect and excellence.

Together we make a difference.