HCL Hiring Life Science candidates for Medical Writer / Clinical Trial Specialist Post | Earn Upto Rs 6 Lakh p.a

Today, HCL is a $6.7 billion leading global technology and IT enterprise comprising two companies listed in India – HCL Technologies and HCL Infosystems. Founded in 1976, HCL is one of India’s original IT garage start-ups. A pioneer of modern computing, today, HCL is a global transformational outsourcing company. Its range of offerings includes product engineering, custom & package applications, BPO, IT infrastructure services, IT hardware, systems integration, and distribution of information and communications technology (ICT) products across a wide range of focused industry verticals.

Job Title : Medical Writer – Clinical Trial Specialist

Location : Hi Tech City, Madhapur, Hyderabad,

Experience : 2 – 6 Years

No of openings : 10

Education : Graduate or Post Graduate in Life Sciences

Salary : INR 3,50,000 – 6,00,000 P.A.

Job Responsibilities:

Primary Role:

• Responsible to work on Clinical study reports, Investigators brochure and Protocol development
• To perform tasks including researching Medical information, summarizing data from clinical studies, consulting, editing statistical and clinical reports
• Review of Medical journals and technical reports
• Developing Protocol, Investigators Brochure , Informed Consent forms, interim reports and Clinical study reports
• Review Protocols , CRFs, ICFs and miscellaneous study documentation
• Working closely with Doctors, researchers and various people in Medical services to provide information which is accurate and easy for others to understand
• Development of disease specific monographs
• Provide protocol related clinical and scientific information to team members and investigators

Project Planning:

• Development of disease specific monographs
• Developing protocol, investigators brochure, informed consent form, interim study reports and clinical study reports
• Review protocols, case report forms, informed consent forms and miscellaneous study documentation
• Development of site feasibility questionnaires
• Preparing study specific feasibility assessment reports

Project Implementation:

• Safety narrative preparation for submission to regulatory authorities
• Preparation and submission of study specific annual safety reports to DCGI
• Investigators brochure updating, protocol amendments and CRF revision during the study

Communications:

• Serve as primary sponsor contact for the project medical writing activities
• Inform to medical team members the scope of work, timelines, and project goals, technical information, and communications from client
  during the project period
• Attend medical and project team meetings and client teleconferences as required
• Interact with other functional units , such as project management , data management and statistics to ensure client satisfaction through successful execution and completion of projects on time and within budget

Project Closeout:

Clinical Study report preparation for regulatory submission after completion of the clinical study

Skills:

• Leadership skills that include the ability to motivate others, and to delegate, and drive time/quality decision making
• Personal qualities that include the ability to gain trust and confidence with a variety of clients as well as within ACT, good learning ability, action oriented and resilience in a fast-paced and rapidly changing environment
• Business/Operational skills that include customer focus, commitment to quality management and problem solving

Minimum Work Experience :  2 years of relevant work experience recommended

Education: –

• Any PhD, MD, Master’s or Bachelor’s degree preferably in Life Sciences
• Medical qualification is not necessarily needed although a good understanding of basic human anatomy and physiology is preferable. Knowledge of disease pathology and their treatment is an advantage.
• Strong understanding of writing techniques is also important.

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