This is an excellent opportunity to join a global medical communications agency to add expertise and presence within their medical device offering in the US. Competitive salary and option of being home based on the East Coast.
The client offers high-quality medical writing and editing services to multinational pharmaceutical and medical device companies, clinical research organizations, and researchers worldwide. They work with over 25 clients located in the UK, US, EU, and APAC and require an experienced writer to act as a subject matter expert in respect of medical devices. Working in a team of in house CER writers (based globally) and mentoring junior writers, to provide medical device clients with clinical publication, regulatory writing, medical communications and clinical evaluation reports.
- Ensure timely production of high quality CERs for devices across therapeutic areas
- Screen and summarize literature for relevant clinical data
- Review literature to elucidate the clinical problem and current treatment techniques
- Study and report device characteristics and instructions for use
- Evaluate data for similar competitor devices
- Summarize post-marketing surveillance and risk management data for the target device
- Work with India-based junior and senior writers to prepare documents that meet client expectations in terms of content, format, and presentation
Working for this world class agency will present exposure to the largest clients within the medical device sector, working to ensure approval for the most innovative and creative healthcare solutions. In return, you will benefit from a supportive culture and the opportunity to grow and develop both professionally and personally. The role also comes with an extensive benefits package and a strong policy of recognition and reward for hard work and success.
- A MD, PhD in Biomedical Engineering or similar degree with knowledge of clinical research, and first-author publications in international peer-reviewed journals
- A Master’s degree with clinical research exposure and significant publications experience can also be considered
- 5+ years of CER writing experience in a medical device company, CRO, or agency
- 1-2 years of regulatory writing experience, with some exposure to medical devices
- Advanced knowledge of 510(k), MedDEV 2.7.1 Rev 4, MDR, and other relevant medical device regulations as well as knowledge of ICH and GCP guidelines.
- Experience across document types and therapeutic areas/diseases/drug classes
- Ability to understand and interpret complex clinical trial data
- Clear, concise scientific style of writing with a high level of attention to detail
- Excellent written and oral English language skills
- Be self-motivated and eager to take on challenges
- Ability to work under tight time lines and manage multiple tasks
- Experience of working with offshore writers will be an added advantage
- Willingness to travel to India office up to 2 times a year
This opportunity will not be around for long, if this role is of interest to you please apply without delay!