Senior Regulatory Analyst

1 - 5 Years
Mumbai, Bengaluru, Hyderabad
Not Disclosed by Recruiter
Posted: 1 day agoOpenings: 1Job Applicants: 2331+Job Views: 4816+

Job Description

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.

Click on the link to watch a short video of what makes us Global Publication Experts: http://bit.ly/2vFUABT

People with international work experience will feel at home with the work culture at CACTUS. 
 
The work environment is very employee-friendly, and some of our honors are:
  • CACTUS was placed 1st among mid-sized Indian companies in the 2017 Great Places to Work
  • CACTUS was placed 18th in Asia among mid-sized Indian companies in the 2018 Great Places to Work
  • CACTUS was ranked 1st as Best Organization for Women Empowerment / Women Talent Development in 2019
Click on the link to watch a short video testimonial on what it means to work with CACTUS as a Scientific Writer:
http://bit.ly/2uIsQd7


Location:
 Mumbai/Bangalore/Hyderabad (Shortlisted candidates should spend 3 months in Mumbai for training)


The opportunity:
If you are looking for challenging and rewarding work which combines your understanding of medical science and aptitude for writing into one unique job, the Data QC Specialist role is for you. 

This is an opportunity to grow your career and make a greater impact on the lives around you.


Roles & Responsibilities:
  • Review regulatory documents (e.g., protocols, amendments, IBs, CSRs, eCTD, summary documents,
  • appendices, and clinical trial disclosures) for data accuracy against source data and consistency
  • between the document text and the in-text tables
  • Check for grammar, syntax, style, and compliance with style guides, regulatory guidelines, and
  • publishing requirements
  • Check documents generated by writers for data errors by checking annotated references
  • Check documents generated by writers for fact errors (discrepancy between source data and
  • document, discrepancy within text, discrepancy between figures/tables and text)
  • Be responsible for the accuracy of data (numerical and otherwise) in the documents/projects assigned
  • Ensure timely delivery of documents

Required Candidate profile

So how do we know that's you? You have the personality and the experience: 

  • Minimum 1-5 years experience in performing QC review of regulatory/scientific documents
  • A university degree (bachelors/masters degree preferably in the pharmaceutical sciences) or
  • equivalent industry experience
  • Ability to work efficiently and independently, multitask, and prioritize
  • Excellent attention to detail
  • Ability to concentrate and work under pressure and meet tight deadlines
  • Excellent written and oral communication skills
  • Functional with Microsoft Word, Excel, and PowerPoint
  • Flexible and adaptable to changing project priorities and work assignments

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:Drug Regulatory Affairs/Documentation

Role:Documentation/Medical Writing

Employment Type:Full Time, Permanent

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:BDS - Dentistry, MBBS - Medicine, B.Pharma - Pharmacy, B.Sc - Bio-Chemistry, Biology

PG:M.Pharma - Pharmacy, Medical-MS/MD - Any Specialization, MS/M.Sc(Science) - Biotechnology, Biology, Microbiology, MDS - Dentistry

Doctorate:Ph.D - Medicine, Pharmacy, Biomedical, Psychiatry, Obstetrics, Radiology, Rheumatology, Biotechnology

Company Profile

Cactus Communications Pvt. Ltd.

Cactus Communications is a leading provider of communication solutions, including academic and scientific editing, medical communications, publication support services, English-language workshops, transcription, and translation. Our company mission is to enable growth through effective communication.

CACTUS offers services to two key client segments worldwide: Academia (researchers, scholarly journals and publishers, universities, and academic societies) and Pharmaceutical and Device companies. With offices in the US, Japan, India, South Korea, Singapore and China, CACTUS has processed more than 690,000 documents from 179,000 clients across 164+ countries in the last 14 years.

Our full-time in-house staff consists of over 500 people and represents a diverse group of people from India, Japan, South Korea, Taiwan, the US, Germany, and Brazil. We also work with over 2500 contractors from around the world. We have over 37 BELS-certified writers/editors in-house (BELS: Board of Editors in the Life Sciences), one of the largest groups of certified editors in the world.

We've been ranked #1 in India's Great Mid-Size Workplaces - 2017, A study conducted by Great Place to Work Institute India in association with MINT, by HT Media.

Cactus Communications is proud to finish 12th in the 2017 list of Top 100 Companies for Remote Jobs by FlexJobs, up from 15th place in 2016!

Specialties scientific editing and publication support, medical writing, translation, English education, publishing, business and media transcription, and brochure and website design and DTP
View Contact Details+

Recruiter Name:Kashish Hiranandani

Contact Company:Cactus Communications Pvt. Ltd.

Telephone:67148888

Address :603/604, 'A' Wing, Satellite Gazebo, Guru Govind Singh Marg, Chakala, Andheri (East), Mumbai 400093, MUMBAI, Maharashtra - 400093,India

Website:http://www.cactusglobal.com

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