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Associate Research Operations

Thousand Oaks, CA
Top 3 Must Have Skill Sets:
    
Scientific writing or technical writing experience including ability to synthesize and verify data/information, proofread, edit, and reformat documents. Familiarity with nonclinical research and understanding of biology/toxicology.
Time and project management skills.
Understanding of the content and organization of regulatory submissions

Description:

Remote - and can remain after covid policy is lifted

Scientific writing or technical writing experience including ability to synthesize and verify data/information, proofread, edit, and reformat documents. Familiarity with nonclinical research and understanding of biology/toxicology.
Time and project management skills.
Understanding of the content and organization of regulatory submissions.

Research Regulatory Operations (RRO) is part of the R&D Operations organization. RRO provides end-to-end program management and quality control support for the nonclinical sections of regulatory submissions, working in close partnership with stakeholders across Research and Global Regulatory Affairs departments.

The prospective candidate will primarily support activities related to scientific study report writing and nonclinical contributions to regulatory submissions. The EW will be responsible for editing draft reports for content and format, coordinating internal and external reviews, and coordinating finalization of reports for regulatory submissions. He/she will be involved in the editing and quality control (QC) of nonclinical sections of regulatory submissions to ensure consistency and accuracy. The EW will manage timelines for the nonclinical contributions to regulatory submissions and will be responsible for ensuring timely completion of work. This role will also require coordination of documents and management of information on a cloud-based document management platform. The role will support seamless communication flow between diverse groups across sites and functional areas and assist with timely issue resolution or escalation.

Competencies
• Scientific writing or technical writing experience including ability to synthesize and verify data/information, proofread, edit, and reformat documents
• Experience in reading, understanding, and applying scientific data integrity checks to nonclinical research study reports and regulatory documents
• Time and project management skills
• Knowledge of GxP regulations, ICH guidelines, eCTD format, drug development process, regulatory affairs, and regulatory compliance
• Proficient in MS Windows, MS Office, Adobe Acrobat, and familiarity working in data management systems
• Strong attention to detail
• Excellent written/oral communication skills
• Ability to independently understand, follow, and implement instructions
• Ability to manage multiple tasks at once and to work effectively with teams using strong interpersonal skills
• Ability to effectively operate in an environment which requires proactive collaboration, analytical judgment, and adherence to critical timelines

Qualifications
Basic Qualifications:
• Bachelor's Degree (Science related - Biology, Chemistry)
• 1 year of science- or quality compliance-related experience within the pharmaceutical, biotech or medical device industry
Preferred Qualifications:
• Bachelor of Science degree
• 3 or more years of experience within the pharmaceutical, biotech or medical device industry, including quality, compliance-related experience and/or nonclinical research experience

"This posting is for Contingent Worker, not an FTE"

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