Associate Pharmacokineticist II

2 months ago

Bangalore, India Labcorp Full time

Service as Principal Investigator or Contributing Scientist for research studies under the direction of the Associate Director of the Pharmacokinetic group or a senior pharmacokineticist. Has overall responsibility for technical conduct of a study, review, documentation and reporting of results.

A. Responsibilities/Duties

ï· Designs and reviews protocol, prepares reports, and carries out kinetic analysis of mostly toxicokinetic studies and occasionally clinical PK/bioavailability/bioequivalence studies with mentorship and guidance to develop general expertise in the field.
ï· Conduct kinetic analysis using noncompartmental approach.
ï· Review analysis plans with clients to determine their needs and to suggest/guide plans to accomplish these needs.
ï· Participates in appropriate client visits.
ï· Provides guidance and leadership to ensure project completion.
ï· Reviews technical validity of projects and test results.
ï· Evaluates experimental data and writes scientific reports.
ï· Assists in development of departmental policies, procedures, and training manuals.
ï· Trains and mentors pharmacokinetic study coordinators and new hires.
ï· Assists in the development of new report formats as needed and improves processes to increase the efficiency of daily/routine procedures and reporting methods.
ï· Reviews study status against initial work plan.
ï· Maintains well documented, organized, and up-to-date study files including study schedule, protocol, and correspondence, as applicable.
ï· Reviews QAU report audits and submits audit responses for SD/management approval.
ï· Reviews client comments and ensures that all necessary report clarifications are completed.
ï· Oversees report productions through finalization, including archival of data.
ï· Maintains positive control over timing and scheduling issues related to every aspect of the study process.
ï· Co-authors scientific papers/posters which are published or presented at scientific meetings.
ï· Assures on-time delivery of high-quality data and reports.
ï· Assures that the final report, including any changes, is approved and in compliance with appropriate SOPs and regulatory agency guidelines.
ï· Provides relevant information to assure accuracy of forecast and revenue recognition.
ï· Performs other related duties as assigned.

B. People Responsibilities:

Acts as coach and mentor to a range of less experienced staff and others, as needed.

C. Essential Job Duties:


ï· Responsible for the design, conduct and reporting of studies to meet scientific regulatory and client requirements.
ï· Reviews technical validity of projects and results, occasionally with consultation of other scientists.
ï· Evaluates data for report preparation and experiment modification, as applicable and writes comprehensive reports.
ï· Discuss project issues or scope changes with the Study Director, suggest solutions and action to solve study issues, manages the impact on time and cost, reviews protocol changes and communicates the status of changes to client and management as necessary.
ï· Assures on-time delivery of high-quality data and reports.
ï· Assures that the final report, including any changes, is approved and in compliance with appropriate SOPs and regulatory agency guidelines.

Required:
ï· Masters with 5-6 years experience in pharmacokinetic data analysis and report writing including 2-3 years experience in prior pharmacokineticist related role or PhD with relevant experien. Relevant experience may be substituted for education.
ï· Knowledge of regulatory agency guidelines.
ï· Effective time management and organizational skills.
ï· Ability to conduct limited review of related literature and references to obtain the required information and subsequently apply it.
ï· Skilled in data interpretation and report writing.
ï· Skilled in interpersonal skills. Team player.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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