Medical Advisor & Medical Writer (specialist) ITALY

At Evidenze we are committed to the biomedical sector and healthcare professionals. We generate scientific evidence and transform it into knowledge to improve routine patient care for real transformation in the health sector.

With more than 300 employees, Evidenze offers a 360º service to the health sector from clinical research, patient support programs, medical training and communication and events.

For our Scientific Advisory & Medical writing department we need to incorporate a proactive professional, eager to grow and work in a multidisciplinary team for the role of Scientific Advisor/Medical Writer specialist. The position is hybrid and can combine teleworking and presence in our offices.

The professional will join a consolidated company within the field of clinical research and will be part of a work team with an excellent work environment, continuous training and great support from the managers and colleagues.

Summary of job description

In the Scientific Advisory & Medical Writer department within the Evidenze Clinical Research (CR) Unit, we are directly involved in the full process of scientific evidence generation, from the design of the clinical studies (real-world evidence [RWE] studies and clinical trials) to the communication and publication of the results derived from clinical investigations in scientific congresses and in biomedical journals. During this process, we closely collaborate with other departments at the CR Unit, including the Clinical Operations (RWE and non-interventional studies department and Clinical Trials department) and Biostatistics departments.

The Scientific Advisor & Medical Writer specialist is responsible for researching, drafting, and revising documents related to clinical research, which includes regulatory documents and scientific publication. Responsibilities also encompass serving as the primary client contact for medical writing projects and collaborating with other departments to meet both internal and external deadlines.

Responsibilities

Preparing Regulatory and scientific documents

• Creating and/or revising documents for regulatory purposes, including research protocols, patient information sheet/informed consent forms, and clinical study reports (CSRs).
• Designing and/or revising case report forms (CRFs) for research projects.
• Developing and/or revising scientific articles and communications for congresses (abstracts, posters, or presentations).
• Developing proposals for the creation of research studies.

Advisory

• Providing advice on the proper methodological development of a research project.
• Offering guidance on ethical principles and current regulations.
• Advising on transparency and best ethical publication practices during the publication process of biomedical research.

Interaction with teams, sponsors and KOLs

• Working closely with sponsors, collaborators, the study team, and investigators to ensure that the design and objectives of the research, as well as the data to be collected for study development, are accurately reflected in the clinical documents to be developed.
• Collaborating with the Biostatistics, Clinical Operations (RWE and non-interventional studies department and Clinical Trials department), and other departments as needed during the preparation, development, and review of regulatory documents and the publication of research.
• Assisting and supporting the Business Development department from a scientific perspective in its relationship with clients/sponsors.

Compliance

• Complying with departmental procedures and requirements, such as completing project assignments within deadlines.

Knowledge and experience

• A degree in Health Sciences (holding a PhD is considered an advantage).
• At least one year of experience in clinical research, medical writing, or any area related to the tasks of the position.
• Proven experience in the scientific methodology of clinical research and epidemiology.
• Fluency in written in English (ability to speak other languages is valued).
• Knowledge of International Conference on Harmonisation - Good Clinical Practice (ICH/GCP) guidelines.

Skills

• Excellent interpersonal communication skills to communicate with managers and colleagues, clients, and other stakeholders throughout the design and development of the research.
• Attention to detail and capacity to consistently produce documents of high quality.
• Analytical skills to critically evaluate and interpret scientific data.
• Ability to understand all necessary steps in a project, plan ahead, and identify critical paths.
• A flexible attitude with respect to work assignments and new learning; readily adapts to changes.
• Efficient in managing time spent on tasks, proactively identifies deficiencies, and manage multiple and varied tasks.
• Prioritizes workload, showcasing strong organizational skills.
• Competent working in a matrix environment and values the importance of teamwork.
• Understands and meets client needs.
• Able to gain trust and establish connections with clients beyond the scope of individual projects, aiming for repeat business and/or to expand existing scope and services.