Senior Scientific Writer (CER: Clinical Evaluation Reports)
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. Clients value the flexible, innovative solutions provided by CACTUS that allows them to manage their budgets wisely and do more with less. 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
We were recently ranked #18 in the top 25 Best Small & Medium Workplaces in Asia – 2018, a study conducted by Great Place to Work® Institute
Location: Andheri East, Mumbai
CACTUS is looking to add an experienced Senior Scientific Writer to it's team of CER writers. The SSW - 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.
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 senior writers to prepare documents that meet client expectations in terms of content, format, and presentation
- Train and mentor junior writers and perform detailed reviews of their deliverables
What’s in it for you?
- Global exposure: We work with the top 10 Pharmaceutical companies across the globe. So you can be assured that you get the best experience in terms of the profile you handle.
- Culture & Team: We never stop recruiting the best people because without an amazing team nothing is possible. People at CACTUS are awesome to work with, driven, smart and know how to get things done like nobody else.
- Learn & Grow: Our goal is to keep you as long possible and help you build a career with us. We do this by creating an environment where you will grow both personally and professionally
- Satisfaction & Recognition: With some of the biggest names across the globe as existing clients, doors will open and conversations will flow. You will see the results of your efforts translate into maximum impact. With a competitive salary and our recognition programmes, you will be rewarded for your success.
So how do we know that’s you? You have the personality and the experience:
- MD, PhD in Biomedical Engineering or a 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 timelines and manage multiple tasks