TFS HealthScience’s Medical Writing Team: Champions of Clarity and Compliance

The Medical Writing team at TFS HealthScience (TFS) stands as a cornerstone in our mission to drive scientific excellence and regulatory compliance. Their dedication to creating high-quality, accessible documents ensures that our clients can bring innovative treatments to market efficiently and effectively.

This article aims to highlight the remarkable work, expertise, and achievements of our medical writing team, showcasing their pivotal role in advancing clinical research and upholding TFS’s commitment to excellence. Let’s start by meeting them!

Meet the Team!

The medical writing team comprises 12 highly skilled medical writers, each with advanced training in medicine and the life sciences. Our team members are located across Europe and the United States. This international presence enables them to bring a wide range of perspectives and expertise to their work. Meet our medical writing leaders below!

Marta Mas, Executive Director of Medical Writing

Marta joined TFS in 2006 and is based in Spain, where she manages the global medical writing Team. With over 20 years of experience in clinical development in both the academic and pharmaceutical industry, Marta brings a wealth of expertise to TFS.

Marta is a Medical Doctor, a specialist in Clinical Pharmacology, and holds a Ph.D. in Medicine and Surgery from the Universitat Autónoma de Barcelona. In addition, she is an associate professor of Pharmacology at the Universitat Pompeu Fabra de Barcelona and a collaborating teacher of an online Medical Writing Postgraduate Course in Universitat Oberta de Catalunya.

Marta has written a wide variety of regulatory documents and has also published in renown journals as an investigator and as a medical writer. She has a wealth of clinical knowledge encompassing multiple therapeutic areas across Phase I-IV trials.

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Catherine Heddle, Director of Medical Writing

Catherine joined TFS in 2007. She holds a BSc in Microbiology and Microbial Technology and a Ph.D. in Biochemistry from Warwick University and the University of Leicester. Catherine is a direct line manager for medical writers in Europe and the U.S., where she mentors writers, project manages, and supports proposal development and writing regulatory documents.

Catherine has experience across a wide range of therapeutic areas and in studies involving medicinal products in Phases 0-IV and medical device investigations (Class I and IIA).

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Andrew Shala, Director of Medical Writing

Andrew joined TFS in 2011. He holds a degree in Biology and Chemical Engineering, an M.Sc. in Biomedical Sciences, and an M.Sc. in Pharmaceutical and Biotechnology from the Universidad de los Andes (University of the Andes) and Universitat Pompeu Fabra de Barcelona.

Andrew is a direct line manager for medical writers in Europe and the U.S. His role includes management of medical writers, writing of clinical study protocols, clinical study reports, abstracts, posters, manuscripts, and other scientific and patient-oriented literature. Andrew has experience across a wide range of therapeutic areas including oncology, rheumatology, cardiology, psychiatry, neurological diseases, metabolic disorders, transplantation (renal and liver), dermatology, and allergy.

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Why Medical Writing is Important

Medical writing plays a critical role in the pharmaceutical and biotech industries. It involves creating well-structured, clear, and accurate documents essential for the successful conduct, reporting, and dissemination of clinical trials and regulatory submissions. Effective medical writing ensures that complex scientific data is presented in a way that meets regulatory requirements and is understandable to a broad audience, including healthcare professionals, regulatory authorities, and patients.

How Medical Writing Helps Sponsors in Clinical Research

1. Regulatory Compliance: Medical writers are well-versed in the latest regulatory standards and guidelines, ensuring that all documents meet the necessary requirements for submissions to regulatory bodies.

2. Clarity and Accuracy: Medical writers transform complex scientific data into clear and concise documents, minimizing the risk of misinterpretation and ensuring that the information is accessible to various stakeholders.

3. Efficiency: By handling the documentation process, medical writers free up researchers and clinicians to focus on their core activities, thereby accelerating the overall timeline of clinical trials and regulatory submissions.

4. Consistency: Medical writers ensure that all documents are consistent in style, format, and terminology, which is crucial for maintaining the integrity of the data throughout the development process.

Recent Work and Achievements

Recently, our medical writing team has made remarkable achievements in producing a broad spectrum of regulatory documents and scientific communications, as well as in presentations at conferences. Here’s a glimpse at what they’ve been up to!

Exhibition at CHaSE Career Fair in Stockholm, Sweden

In November 2023, our Director of Medical Writing, Catherine Heddle, and Medical Writer, Nicole Bezuidenhout, participated in the Careers in Health and Science Exposition (CHaSE) in Stockholm, Sweden, to inspire life science graduates to pursue a career in medical writing. During the event, they shared their personal experiences and offered valuable tips for entering the field. Additionally, they highlighted the rewarding aspects of working at a global mid-sized CRO.

Women in Clinical Trials at Medicon Valley Alliance

In March, the Lund office welcomed Marta Mas, who was the key speaker at two events: Science for Breakfast and Women in Clinical Trials. Marta shared key insights into TFS as a company, our medical writing practices, and women’s representation in clinical trials.

Marta Mas at the 57th European Medical Writers Association Conference

Poster Presentation at the 57th European Medical Writers Association Conference

In May, Marta Mas and Senior Medical Writers, Irene Mansilla and Anaïs Estrada, attended the 57th EMWA conference in Valencia, Spain. Marta presented our findings on the awareness and perceived utility of graphical abstracts in scientific publishing, and Irene presented findings on our study of sex bias in randomized clinical trials published in high-impact journals.

Medical Writing Team’s Core Capabilities and Expertise

Our medical writing team brings extensive and diverse expertise across various therapeutic areas, indications, and document types.

Core Capabilities:

Regulatory Document Preparation: Creation of comprehensive regulatory documents such as Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), and Common Technical Documents (CTDs) for submission to regulatory authorities.
Clinical Trial Documentation: Development of crucial clinical trial documents, including study protocols, informed consent forms, and clinical trial applications.
Scientific Publications: Writing and editing manuscripts, abstracts, posters, and presentations for scientific journals and conferences.
Medical Communications: Preparation of medical communications materials such as slide decks, newsletters, and educational materials for various stakeholders.
Quality Control: Ensuring high standards of accuracy, clarity, and consistency in all documents through rigorous quality control processes.
Regulatory Compliance: Keeping up-to-date with the latest regulatory guidelines and standards to ensure all documents meet the necessary compliance requirements.

Expertise:

Therapeutic Area Knowledge: An in-depth understanding of various therapeutic areas enables precise and relevant documentation across different medical fields.
Technical Writing Skills: Expertise in transforming complex scientific data into clear, concise, and understandable documents tailored to different audiences.
Project Management: Strong project management skills to coordinate writing activities, meet deadlines, and manage multiple projects simultaneously.
Research and Analysis: Ability to conduct thorough literature reviews, analyze clinical data, and integrate findings into coherent documents.
Collaboration and Communication: Effective communication and collaboration with clinical teams, researchers, and regulatory authorities to gather necessary information and ensure alignment on document content.
Multilingual and Multicultural Competence: Proficiency in multiple languages and understanding of diverse cultural contexts, facilitating global communication and documentation.
Ethical and Regulatory Standards: In-depth knowledge of ethical guidelines and regulatory requirements, ensuring documents adhere to the highest standards of integrity and compliance.

By leveraging these core capabilities and expertise, medical writers significantly contribute to the efficient, accurate, and compliant development and submission of clinical research documentation, ultimately aiding sponsors in bringing innovative treatments to market.

What Sets TFS’s Medical Writing Team Apart?

The TFS medical writing team stands out for its unique blend of diversified skills and geographical and cultural diversity. We offer services in multiple languages and understand local practices and customs. Over the years, our team has demonstrated exceptional flexibility and capability, successfully delivering on a wide range of projects, from regulatory documents to scientific publications and creative communications.

Our team members bring a deep passion for medical writing, science, and patient well-being, coupled with an inquisitive mindset and growth-oriented approach. This commitment to continually embracing new ideas, technologies, and information ensures that we consistently improve our processes and outputs to better support our clients’ needs.

Noteworthy advantages include the ability to transform complex scientific information into accessible communications tailored to diverse audiences, leveraging cutting-edge technologies for efficient document production, and maintaining a patient-centric focus throughout the entire writing process. This approach not only ensures regulatory compliance and high-quality deliverables but also fosters trust and transparency in our communications, ultimately contributing to the advancement of healthcare and patient care.

What to Expect from TFS’s Medical Writing Team

Sponsors partnering with a top-tier medical writing team like TFS’s can expect high-quality, accurate, and meticulously crafted documentation that adheres to the latest regulatory guidelines, ensuring compliance and minimizing the risk of delays. Our team possesses in-depth therapeutic area knowledge and advanced technical writing skills, translating complex scientific data into clear and engaging content. With streamlined workflows and strong project management practices, they guarantee timely deliverables, supporting efficient project progression.

Effective communication and close collaboration with clinical teams and stakeholders are hallmarks of our top-tier medical writing team. They utilize cutting-edge tools and technologies for enhanced accuracy and efficiency and are adaptable to the evolving needs of projects. Offering comprehensive support across various services, including regulatory document preparation and scientific publications, our team provides strategic insights and risk mitigation to ensure smooth regulatory submissions and approvals, ultimately aiding sponsors in bringing innovative treatments to market.

At TFS, our medical writing team exemplifies our commitment to excellence, innovation, and collaboration. Their dedication and achievements highlight their immense value to both TFS and our clients.

TFS CRO, Your Partner for Medical Writing

At TFS, we pride ourselves on being a reliable and strategic partner for your medical writing needs. Our team of seasoned medical writers brings a wealth of expertise, ensuring that your clinical research documentation is not only of the highest quality but also meets the stringent regulatory requirements essential for successful submissions. We understand the critical role that clear, accurate, and compliant documentation plays in the pharmaceutical and biotech industries, and we are committed to delivering exceptional results that support your innovative treatments.

To learn more about our medical writing capabilities and how we can support your clinical research projects, download our comprehensive one-pager on TFS Expertise in Medical Writing.

For additional information, or to discuss your specific needs, visit our medical writing page or contact a TFS team member today. We look forward to partnering with you!