Clinical Records Associate I
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POST DATE 9/10/2016
END DATE 1/6/2017
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Meet the team: http://clinicaloperations-careers.gilead.com/
ESSENTIAL DUTIES AND JOB FUNCTIONS
Gilead Sciences in Foster City, CA is hiring for a Process Improvement Specialist for our
Clinical Operations team.
Essential Duties and Job Functions:
-Support continuous improvement projects and process development within Clinical Operations.
-Assists in establishing and maintaining standard processes within Clinical Operations.
-Lead the development and maintenance of SOPs and WRKs, and corresponding training materials.
-Collects, summarizes, and analyzes data for continuous improvement considerations.
-Participates in testing of processes, concepts, and tools for implementation.
-Collaborates cross-functionally to achieve operational excellence.
-Works with key stakeholders to ensure that operational activities are compliant with applicable
US and global regulations.
-Identifies best practices and work to standardize practices to processes.
-Anticipates moderately complex obstacles and client difficulties and implements solutions to achieve project goals.
-May design and use all available vehicles for scientific communication within company.
-With limited supervision may participate in departmental strategic initiatives.
-Travel may be required
KNOWLEDGE, EXPERIENCE AND SKILLS
-Typically requires a BS or BA in a relevant scientific discipline and minimum 8-10 years relevant clinical experience in the pharmaceutical industry or equivalent.
-Excellent interpersonal skills, and demonstrated ability to lead is required.
-Experience in mentoring junior staff.
-Strong communication and influence skills and ability to create a clear sense of direction is necessary.
-Excellent problem solving skills.
-Functional expertise to author and contribute to SOP/ WRK development, implementation, and training.
-Demonstrated ability to successfully initiate, manage and complete clinical trials.
-Thorough knowledge and understanding of FDA and EMEA Regulations, ICH Guidelines, and
GCPs governing the conduct of clinical trials.
-Ability to examine functional issues from a broader organizational perspective.
-Ability to participate in departmental or interdepartmental strategic initiatives under limited supervision
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance. For more information about equal employment opportunity protections, please view the EEO is the Law poster
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
For more information about equal employment opportunity protections, view the EEO is the Law poster at :