Freelance Medical Writer - Clinical Evaluation Reports (CERs)
Who we are:
CACTUS provides scientific writing services to the Top 10 global pharmaceutical, biotech, and medical device companies. The team comprises writers with advanced degrees in medicine or the life sciences.
CACTUS is recognized for its expertise in providing publications and medcom services to global client teams from the US, UK, Germany, and Japan, among other geographies. CACTUS acts as a trusted advisor and works as an extension of its client teams by not only delivering high-quality work consistently, but also providing strategic guidance for their medical communications needs. Click on the link to watch a short video of what makes us Global Publication Experts: http://bit.ly/2vFUABT
CACTUS is a performance-driven company that offers excellent professional and personal growth opportunities to it employees. People with an international work experience will feel at home with the work culture at CACTUS.
The work environment is very employee-friendly, and CACTUS was placed 1st among mid-sized Indian companies in the 2017 Great Places to Work survey: http://bit.ly/2uiJmUv
CACTUS is looking to add an experienced Senior Medical Writer(SMW) to its team of Clinical Evaluation reports (CERs) writers. The SMW - CER will be involved in development of high-quality Clincial Evaluation Reports, Clinical Evaluation Plans, and related documents in compliance with MedDev 2.7.1 Rev 4 guidance. Although the position is based in the US/UK, the candidate is also expected to work closely with a team of writers based in India by mentoring and reviewing the work of junior writers. Candidates are also expected to engage clients in discussions around project scope and with cross-functional team members involved in CER development.
Roles & Responsibilities:
- 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 clientexpectations in terms of content, format, and presentation
What’s in it for you?
1.Global exposure: We work with the top 10 Pharmaceutical companies across the globe. So you can beassured that you get the best experience in terms of the profile you handle.
2.Culture & Team: We never stop recruiting the best people because without an amazing team nothingis possible. People at CACTUS are awesome to work with, driven, smart and know how to get thingsdone like nobody else.
3.Learn & Grow: Our goal is to keep you as long possible and help you build a career with us. We do thisby creating an environment where you will grow both personally and professionally.
4.Satisfaction & Recognition: With some of the biggest names across the globe as existing clients, doorswill open and conversations will flow. You will see the results of your efforts translate into maximumimpact. With a competitive salary and our recognition programs, you will be rewarded for your success.
How to apply?
Send your updated CV along with a cover letter to firstname.lastname@example.org. Feel free to write to us in case you have any queries.
So how do we know that’s you? You have the personality and the experience:
An 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