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Clinical Trials

Pfizer


Location:
Groton, CT
Date:
03/21/2017
Job Code:
1036372-1852
Pfizer
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Job Details

Job Title Clinical Trials

JobID 1036372-1852

Location: Groton, CT

Description *About Pfizer*

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.



*Role Description*

Must be located near a Pfizer site, relocation is not provided.*Lead the development, revision, process mapping, implementation and maintenance of procedural documentation (policies, standard operating procedures and supporting documents) related to Pfizer global clinical trial activities.*Provide strategic recommendations regarding SOP development and supporting systems at the divisional and global levels. *Manage a core departmental process or function as assigned by the Worldwide Head SOPs, Training & Compliance.



*Responsibilities*

The key responsibilities of the Process and Procedure Development Lead include:*Collaborate with business process owners to identify changes or improvements required to procedural documentation based on regulatory changes, audit/inspection findings, business needs or changes in industry standards.*Lead a team of global subject matter experts in the development or revision of procedural documentation using process design and project management principles*Ensure that the documentation produced meets regulatory requirements, is designed with operational effectiveness in mind and contains measurable control steps where applicable.*Work proactively with Training representatives to develop training strategy including recommending curricula assignments, materials development and communications required to support the roll out of revised processes.*Manage queries from the organization related to assigned policies/SOPs.*Maintain procedural documentation in a manner that supports corporate compliance and inspection readiness objectives. *Assist in audit coordination/conduct and inspection support/follow-up, as required, in collaboration with research and business units and platform lines.*Serve as departmental representative on key process redesign initiatives*Manage a core departmental process or function as assigned by WW Head SOPs, Training & Compliance



*Qualifications*

Training & Education A scientific or technical degree is preferred.In general candidates for this job would have the following levels of education/ relevant experience:*BS and over 10 years*MS and over 5 years Prior Experience:*Experience in clinical research or clinical trial operations*SOP management and implementation background required*Demonstrated project management expertise*Demonstrated process development expertise*Demonstrated excellent verbal, written, presentation skills required*Collaboration, interpersonal and facilitation skills required*At least 2 to 4 years of experience in managing multiple complex projectsTechnical Competencies:*Demonstrated knowledge of clinical research processes and regulatory requirements; ability to gain command of process details.*Demonstrated knowledge of process design and documentation techniques.*Demonstrated ability to manage multiple complex projects and cross-functional processes*Demonstrated outstanding written communication skills*Application of in-depth analysis and identification of multiple solutions to complex problems; shape courses of action with senior management *Demonstrated ability to provide to management objective advice and assistance relating to the strategy, structure, management, and operations of an organization in pursuit of its long-term purposes and objectives. Such assistance may include the identification of options with recommendations; the provision of additional resources and/or the implementation of solutions*Champion of change and best practices*Demonstrated knowledge of continuous improvement practices and methodologies



*EEO & Employment Eligibility*

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.





*Clinical Trials*
*Groton, Connecticut*
*1036372-1852*


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