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On behalf of our client, a growing medical technology company, we are currently recruiting for a Medical Writer/Clinical Research Associate.

Position Overview:

The company are now seeking to expand their clinical research team to work on various elements of clinical research projects but to primarily assist on scientific and medical writing for internal and external dissemination purposes. This role reports directly to the Director of Clinical Research to coordinate and manage tasks but will also work closely with the Scientific Communications Manager.

You will work with clinical research and clinical affairs teams to fully understand the patient journey, internal processes and data available in order to create the appropriate material for a variety of projects. You will be tasked with interpreting and reporting on patient and commercial data gathered internally or with external partners, this may be in the form of peer-reviewed journal articles or trade journals for example. You should have experience at creating clinical documentation required as part of ethics submissions and the completion of research projects in line with the required regulation of a region (ISO 14155, MDR, FDA etc.).

Position Responsibilities and Essential Functions

• Write and edit high-quality scientific journals, abstracts, white papers, review articles, research papers, regulatory documents, and study documents (including protocols and clinical investigation reports) related to neuromodulation in the tinnitus field and adjacent areas of interest.
• Perform comprehensive literature reviews to understand the current state of research and place new findings in context. Synthesize information from multiple sources to provide a balanced overview of a topic.
• Keep abreast of new developments and industry trends and update content as needed.
• Collaborate planning of content of scientific publications and verify data with our internal study team.
• Ensure that documents adheres to the organization's and editorial writing guidelines, and are appropriately stored and organized.
• Ensure that all content complies with ethical guidelines, including transparency, avoiding conflicts of interest, and ensuring the integrity of the scientific record.
• Handle sensitive information appropriately and maintain confidentiality where necessary.
• Support the creation of visual aids, such as graphs, charts, and diagrams, to enhance the written content.
• Ensure proper citation and referencing of sources.
• Edit and revise new and existing content for clarity, grammar, style, factual accuracy and changes in understanding.

General

• Lead by example in complying with the policies, procedures, and work instructions
• Comply with the procedures for retention, protection, retrieval, transfer, and disposal of records.
• Contribute to team effort by accomplishing related results as needed.
• Thoroughly document all issues related to quality assurance, GCP, GDP, and ISO compliance.

Education, Qualifications and Experience:

• A PhD or Master's Degree in life science, psychology, medical science, or biomedical engineering or equivalent industry experience in research/medical writing roles.

Required:

• 3+ years of writing experience in the healthcare or medical device industries or in a post-doctoral position.
• Experience publishing in peer-review scientific journals and with the review process.
• Broad & in-depth expertise in clinical concepts and regulations.
• Exceptional technical writing skills.
• Knowledge of medical/scientific terminologies.
• Excellent analytical thinking, ability to plan, organise and implement multiple concurrent tasks.
• Strong attention to detail and commitment to quality.
• Excellent communication skills and be able to explain your work, theories, and results.
• Capable of initiating and leading change.
• Data visualization and reporting.
• A team player with excellent interpersonal and communications skills, with the ability to solve problems ad-hoc.

Preferred:

• Relevant experience in the tinnitus, audiology, pain or neuromodulation fields.
• Good understanding of research design methodology
• Self-motivation so you can work with limited supervision.
• Clinical statistical analysis and data exploration (strong interest).
• Experience in managing multiple content and studies at different stages.
• Great attention to detail.
• Excellent verbal communication skills.

Physical Demands

Must be willing to travel internationally

For full details contact Linda at or email your CV to Thornshaw Scientific is a division of the CPL Group