Senior Medical Writer: Clinical Evaluation Report (cers)

Cactus Communications

1 - 3 yrs

Mumbai Suburbs , Mumbai

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Not Disclosed by Recruiter Openings: 2 Posted 5 days ago

Job Description

 

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CACTUS Medical offers medical writing services to multinational biopharmaceutical and devices companies, clinicalresearch organizations, and researchers worldwide. We work with clinicians and researchers to help them communicate their science to the world. We are currently looking to add to our team, experienced medical writers who have exposure to regulatory writing as well as hands-on experience of writing on medical devices or CER writing experience, and who aspire to be part of a world-class delivery team, and work in an exciting, fast-paced global environment.

As a CER writer in the CACTUS Medical team, you will:


• 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

Location: Andheri (West)

Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:R&D
Role:Clinical Research Manager

Keyskills

Clinical Research Medical Writing Medical Devices Risk Management CER clinical evaluation report pharma evaluation report medical evaluation report

Desired Candidate Profile

Education-

UG: B.Sc - Any Specialization, MBBS - Medicine
PG:M.Sc - Any Specialization, M.S/M.D - Any Specialization
Doctorate:Ph.D

Qualification:


• PhD (preferably in the pharmaceutical sciences)/MBBS/MD with knowledge of clinical research, and first-author publications in international peer-reviewed journals. 
• A Masters degree with clinical research exposure and significant publications experience can also be considered. 


Experience:


• 1-3 years of CER writing experience 
• 1-2 years of regulatory writing experience, with some exposure to medical devices
• Advanced knowledge of clinical research processes and drug development, as well as ICH, GCP, and other such industry 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
• Ability to work under tight timelines and manage multiple tasks

Company Profile:

Cactus Communications

Cactus Communications is a leading provider of scientific communication services to more than 60,000 clients across 116 countries. In line with its mission-to enable growth through effective communication-CACTUS offers specialist academic editing, medical communications, publication support, transcription, translation, and training services to individuals and corporations across sectors such as academia, publishing, and pharmaceuticals.

Combining the rich experience of a multi-national, multi-functional team; the peerless capabilities of over 1400 language and business professionals; and ingenious technological innovation, CACTUS helps researchers, journals, universities, and corporations achieve their publication goals. The CACTUS culture is an eclectic yet inclusive one, where people from different countries and professional backgrounds come together to form a global team that pursues excellence, prizes integrity, and works as a unified client-focused organization.

Offices
United States | Japan | Brazil | India | South Korea | Taiwan | China

Awards and Recognition

*2014: Ranked 1st in the Professional Services category and as India's 10th best workplace overall in the Great Place to Work Institute survey (Ranked among top 20 from 2011- 2013)

*2010: Red Herring Global 100 Award, for innovation in business

*2008: Featured among the Top 15 Exciting Emerging Companies 2008, in a NASSCOM survey 

 

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