About us : HCLTech is a global technology company, home to more than 223,400 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2023 totaled $12.8 billion. To learn how we can supercharge progress for you, visit hcltech.com. Website - http://www.hcltech.com
Job Details :
- Responsible to work on Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-market clinical follow-up (PMCF), Summary of Safety and Clinical Performance (SSCPs), state of the art (SOTA) on medical devices, post market surveillance reports, Periodic safety update reports, Literature reviews, Protocol development, Clinical study reports, and Investigator’s brochure, Clinical Evidence Summaries, Risk-benefit analysis reports for medical devices as per MDD and MDR requirements.
- To perform tasks including literature search, summarizing and analyzing data from clinical studies, consulting, editing statistical and clinical reports.
- Review of medical journals and technical reports.
- Working closely with doctors, researchers and other medical services personnel to provide information which is accurate and easy for others to understand.
- Review and update various sections of clinical evaluation reports, PMS reports, case report forms, informed consent forms, Clinical Evidence Summaries, Risk-benefit analysis reports. and miscellaneous study documentation
- Serve as primary sponsor contact for the assigned project medical writing activities
- 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.
Education: Graduate or post graduate degree or PhD in life sciences, Masters in Pharmacy, Doctorate of Pharmacy (Pharma D), or Biomedical Engineering.
Skills:
- Personal qualities that include the ability to gain trust and confidence with a variety of clients as well as within HCL, good learning ability, action oriented and resilience in a fast-paced and rapidly changing environment
- Effective communication skills that include the provision of timely and accurate information to stakeholders, strong written and oral communication skills, computer literate: MS Office
- Demonstrated ability in the following areas: Excellent communication skills, both verbal and written, effective interpersonal skills, ability to work independently and collaboratively on project teams, interface with investigative sites, and recognize safety and efficacy data trends.
- Attributes: Self-motivated and motivational, self-starter, positive team player, adaptable.
Qualifications:
- Any PhD or Master's or Bachelor's degree in Life Sciences – B. Pharm, M. Pharm, PharmD, Biomedical Engineering, Medical Microbiology, Biotechnology, Pharmaceutical Engineering.
- Basic understanding of human anatomy and physiology is preferable.
- Knowledge of disease pathology and their treatment is an advantage.
- Knowledge on Medical Devices also preferred.
- Good understanding of writing techniques is also important.
