Job Description

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.

You will work independently on preparing and finalizing high-quality clinical and regulatory documents in accordance with company policies, SOPs, and global regulatory requirements.

Please, keep in mind that this is a direct-recruitment to one of our clients, a Big Pharma company, and requires working on-site from their office in Gaithersburg, Maryland, 3 days per week.

Key Responsibilities

• Author and review clinical and regulatory documents including:
  • Clinical Study Protocols, Clinical Study Reports, and Investigator’s Brochures
  • Statistical Analysis Plans, Clinical Summaries, and Clinical Overviews
  • Patient Narratives, Manuscripts, and Journal Publications
  • IMPDs, Monographs, and Subject Information documents
• Conduct literature reviews and ensure scientific accuracy and consistency across all deliverables.
• Provide strategic input and methodological advice to clients and internal teams.
• Participate in client meetings and liaise with Key Opinion Leaders and medical experts.
• Manage resource allocation, project staffing, and contribute to business proposals and contracts.
• Drive the development of departmental routines and best practices to enhance efficiency and quality.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, or a related field (advanced degree preferred).
• Minimum 3 - 5 years’ publication experience .
• Strong knowledge of medical terminology and global clinical development processes.
• Excellent writing, editing, and organizational skills with exceptional attention to detail.
• Strong verbal communication and client-facing abilities.
• Experience working with monoclonal antibodies and infectious disease s 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.

Job Tags

Contract work, Work at office, Flexible hours, 3 days per week,

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