Mgr, Biopharmaceutics

Our Strength Is Our People. Passion. Principles. Perspective. At Watson, they're the traits that drive our growth and we apply them to every project and product. If you bring these qualities to your work, then we'd like you to consider joining our team.Summary: Under general direction, plans, monitors and concludes bioequivalence studies completed by Contract Research Organizations (CROs) in order to obtain FDA approval of the
Company's ANDAs of new generic drug products. Carries out managerial responsibilities in accordance with the organization's policies and procedures, state, federal and local laws.
Plans, monitors and works closely with Contract Research Organizations (CROs) to conclude bioequivalence studies in order to obtain FDA approval of the Company's products. Involves reviewing clinical study protocols and bioanalytical validation reports, and conducting pre-study site audits of CRO responsible for the completion of the study.
Conducts CRO site visits in preparation of FDA audits. Ensures that bioequivalence data and test materials located in study site are found satisfactory and are qualified for approval by FDA. Records information and reports findings relating to the site visits.
Ensures that the studies are completed according to good clinical practices and that all data is accurate.
Monitors dosing and conduct of bioequivalence studies and files study monitoring reports.
Assists in the review, approval and coordination of providing clinical supplies designated for multiple sites as well as shipment of necessary documents.
Participates in company wide SOP training program, as well as R&D administrative matters pertaining to internal policies of R&D department, the company and archiving of study documents.
Complies with all Company policies and procedures, including safety rules and regulations.Qualifications
Knowledge of:
Pharmaceutical principles, practices, and application
Personal computer hardware and software applications
Business English usage, spelling, grammar and punctuation
Pertinent federal, state and local laws and regulations
Current Company policies and procedures, including personnel and safety policies and proceduresSkill in:
Implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources
Analyzing problems, identifying alternative solutions, analyzing consequences of proposed actions, and implementing recommendations that support department goals
Interpreting and applying medical information, regulations, and guidelines pertaining to pharmacology, chemistry, pharmacokinetics, bioequivalence and product development.
Responding to inquiries from management, employees and regulatory agencies
Communicating clearly and concisely, both orally and in writing
Ensuring compliance with company policies, practices and procedures, including safety rules and regulation
Establishing and maintaining cooperative working relationships with others.
Managing, coordinating, delegating assignments and reviewing the work of assigned department personnel
Managing multiple projects, duties and assignments
Interpreting and applying medical information, regulations, and guidelines pertaining to pharmacology, chemistry, pharmacokinetics, bioequivalence and product developmentWatson offers competitive medical and dental benefits, including vision, 401(k) and educational reimbursement.Watson Pharmaceuticals, Inc. is an Equal Opportunity Employer M/F/D/V. We value the benefits of diversity.Apply Online Now!
REQUIREMENTS
Please see Job Description