clinical research projects; develops, publishes and presents research to enhance the Company’s
public image; and provides technical support to Company departments as needed.
Under administrative direction, manages the planning, coordination and execution of
Essential Job Functions:
representative summary of the major duties and responsibilities. Incumbent(s) may not be
required to perform all duties listed, and may be required to perform additional, position-specific
This is not intended as a comprehensive list; it is intended to provide a
and state, federal and local laws.
Carries out responsibilities in accordance with the organization’s policies, procedures,
formulating strategies, prioritizing tasks, and developing timetables for conducting project
specific clinical trials.
Plans and conducts studies to illustrate new uses for Company products; assists in
data analysis and management systems, and clinical monitoring for assigned projects;
and assures that investigations follow protocols.
Coordinates the development and implementation of study protocols, case report forms,
clinical projects; assists in coordinating the activities of the clinical research department
staff; and assures compliance with federal regulations affecting the clinical evaluation of
Assists in the design of case report forms and other documents required for specific
supports marketing in development of scientific materials; supports regulatory affairs with
technical responses on biopharmaceutical issues.
Writes and develops grant proposals, project reports and professional publications;
research information to academic and corporate entities to support the Company’s
products and commercial goals; communicates the scientific and medical community’s
concerns, ideas and issues to Company management.
Presents clinical investigations, findings, theories, data interpretation, and other scientific
study designs, data interpretation, and other scientific and conceptual issues as required.
Consults with product managers and advisory boards on medical and safety issues,
unsolicited clinical research protocols to the Company.
Interacts and collaborates extensively with academic thought leaders who submit
Assures assigned project deadlines and performance standards are established and met.
Assures compliance with all Company policies and procedures, including safety rules and
Performs related duties as assigned.
Required Knowledge and Skills:
Enforcement Agency and Regulatory Affairs clinical requirements and cGMP’s.
Pertinent Federal and State laws related to Pharmaceutical industry; current FDA, Drug
modalities and trends.
Pharmaceutical research techniques and methods; medical terminology and treatment
Clinical studies design and principles of trial management.
Project management principles and techniques.
Business, scientific and personal computer hardware and software applications.
Business English usage, spelling, grammar and punctuation.
Current Company policies, practices and procedures, including safety regulations.
cost effective management of allocated resources.
Implementing strategic plans, goals, objectives and practices for effective, efficient and
Preparing and presenting information to medical, public, technical and scientific groups.
proposed actions; and implementing recommendations.
Analyzing problems; identifying alternative solutions; projecting consequences of
Communicating clearly and concisely, both orally and in writing.
Managing multiple projects, duties and assignments.
Interpreting and applying Federal, state and local policies, procedures, laws and
Establishing and maintaining cooperative working relationships with others.
Physical Requirements and Working Conditions:
extended periods of sitting, standing, walking, and vision to monitor, and moderate to loud noise
levels. Incumbents may be exposed to toxic materials, toxic gases, electrical hazards, dangerous
tools and equipment and the antibiotics penicillin and cephalosporin. Work is performed in office
and laboratory environments.
Incumbents in this class are subject to
college or university, and six (6)) years pharmaceutical clinical experience, or an equivalent
combination of education and experience, including at least two (2) years at the director level.
Pharmaceutical industry experience preferred
: Ph.D., M.D. or Pharmaceutical Doctorate Degree from an accredited
As its name implies, the Actavis U.S. is the US manufacturing and marketing unit of global generics firm Actavis. The company makes some 150...