Description

Identification and development of clinical study designs as per current global customer requirements. Guiding the medical writing team on scientific and regulatory aspects of the clinical study designs. Facilitating with the clinical bioanalytical teams on continual improvements of medical writing process. Evaluation of whether all the drugs are received, stored, dispensed, achieved/ disposed as per the applicable procedure. Responsible for qualification and calibration of pharmacy, equipments and other major instruments used in clinical studies. Responsible for identification, evaluation of current clinical study designs and practices suggested/ accepted by various regulatory authorities. Responsible for identification, procurement, qualification of appropriate pharmacokinetics and statistical software for routine analysis form time to time Responsible for qualification/validation of computer systems, software, macros used in the regulatory environment . Provide guidance and scientific direction for creative designs and inputs into clinical study reports as appropriate. Responsible for the review and delivery of scientifically accurate content that is aligned with study objectives and meets the specification of the sponsor. Scheduling and budgeting of medical writing, pharmacokinetic and statistical analysis projects. Identification, evaluation and provision of adequate resources including man power, computer systems and software. Responsible for internal and external communication on study related matters. Responsible for conducting appropriate independent quality control measure in medical writing, pharmacy, pharmacokinetic and statistical analysis Responsible for training employees on relevant procedures, regulations and customer requirements. Preferred candidate profile: Interested applicants with eligible qualification can send their profiles to [email protected]

Role and Responsibilities

• Identification and development of clinical study designs as per current global customer requirements. Guiding the medical writing team on scientific and regulatory aspects of the clinical study designs. Facilitating with the clinical bioanalytical teams on continual improvements of medical writing process. Evaluation of whether all the drugs are received, stored, dispensed, achieved/ disposed as per the applicable procedure. Responsible for qualification and calibration of pharmacy, equipments and other major instruments used in clinical studies. Responsible for identification, evaluation of current clinical study designs and practices suggested/ accepted by various regulatory authorities. Responsible for identification, procurement, qualification of appropriate pharmacokinetics and statistical software for routine analysis form time to time Responsible for qualification/validation of computer systems, software, macros used in the regulatory environment . Provide guidance and scientific direction for creative designs and inputs into clinical study reports as appropriate. Responsible for the review and delivery of scientifically accurate content that is aligned with study objectives and meets the specification of the sponsor. Scheduling and budgeting of medical writing, pharmacokinetic and statistical analysis projects. Identification, evaluation and provision of adequate resources including man power, computer systems and software. Responsible for internal and external communication on study related matters. Responsible for conducting appropriate independent quality control measure in medical writing, pharmacy, pharmacokinetic and statistical analysis Responsible for training employees on relevant procedures, regulations and customer requirements. Preferred candidate profile: Interested applicants with eligible qualification can send their profiles to [email protected]