Senior Medical Writer For BABE/CRO

• Role & 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 hr@qpsbioserve.com