Senior Technical Lead

Job Summary

Primary role:

• Responsible for creation and update of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) of Medical Devices as per MEDDEV Rev 4 and MDR regulations.

• Should have experience in handling reports such as Subject Device and State of the Art Literature Reports, Post Market Surveillance (PMS Plan), Post Market Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), Post-market clinical follow-up (PMCF) Plan and Post-market clinical follow-up Report and Summary of safety and clinical performance (SSCP)

• Responsible to work on Protocol development, Clinical study reports, and Investigator’s brochure, Clinical Evidence Summaries, Risk-benefit analysis reports.

• To perform tasks including literature search, summarizing and analyzing data from clinical studies, consulting, editing statistical and clinical reports

Key Responsibilities

• Create initial CEP and CERs

• Review and update CEP, CER, SSCP. In addition, basic PMS Plan, PMSR, PSUR, PMCFP and PMCFER, Clinical Evidence Summaries, Risk-benefit analysis reports.

• Serve as primary contact for the assigned 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 with strict adherence to timelines and within budget

Skill Requirements

• 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.

• Exceptional hold over proofreading and grammatical skills.

• Experience in using databases/ tools such as End Note, OVID/ EMBASE/Pub Med, DistillerSR, Perfect It, Grammarly

• 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, willing to travel, as needed.

Other Requirements

Qualifications:

• Any Master's or Bachelor's degree in Life Sciences – B. Pharm, M. Pharm, PharmD, Medical Microbiology, Biotechnology, Pharmaceutical Engineering.

• Basic understanding of human anatomy and physiology is preferable. Knowledge of disease pathology and their treatment is an advantage.

• Good understanding of MDCG, MEDDEV 2.7/1 Rev 4 and EU MDR

• Good grasp over medical writing techniques is eminent.