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 (job title) is responsible for timely delivery of high-quality clinical regulatory-compliant documents.

As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical company.

Please keep in mind that this is a full-time hybrid role with 3 days in the office in Warsaw, Poland.

Key Responsibilities

• Provide clear leadership and accountability, strategic vision, and planning direction at the global function level for clinical regulatory documents.

• Review to ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards.

• Ensure consistent support and implementation of MW standards and maintain adherence to standard operating procedures and regulatory requirements in partnership with statistical, clinical, regulatory, quality, and drug safety colleagues.

• Work in close collaboration with the MW team to drive best practices and support for innovation, capabilities, efficiency, and resourcing.
  

Qualifications

• Significant experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry environment in positions with increasing levels of responsibility.

• Includes proficiency at authoring/editing and managing the writing/review of multiple types of clinical regulatory documents and submissions and extensive knowledge and experience relevant to multiple therapeutic areas, disease areas, and technical disciplines.

• Proven ability to advise and lead communication projects.

• Broad cross-functional understanding of the drug development process from scientific, technical, and business perspectives. In-depth knowledge of the technical and regulatory requirements related to the role.

• Extensive knowledge of the latest technical and regulatory documentation expectations desirable.

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.