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Associate Research Operations

Thousand Oaks, CA

“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puert Rictbe vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”

Top 3 Must Have Skill Sets:                                                        
  • Scientific writing or technical writing and editing 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 and regulatory filing processes.
Day Day Responsibilities:                                    
  • May include any of the following:
  • Editing: Reports and regulatory filing documents.
  • Document creation: Providing templates for authors within the document management system, creating nonclinical tabulated summary tables
  • QC and review: Regulatory filing documents.
  • Project Management and communication: Manage timelines and tasks for successful completion of a regulatory filing.
  • Meetings: Facilitate optimization strategy meetings, facilitate/actively participate in internal department meetings, attend and contribute to regulatory filing meetings as the nonclinical program manager.
  • The successful candidate will develop expertise in the nonclinical aspects of filings, be able to work independently in a very deadline-driven environment, have the skillsets to deliver a quality document for a filing, can oversee completion of work for many people and tasks, and is confident in presenting at and facilitating meetings.

Summary
Expected start would be after the holiday around 1/3/2022.
Core hours would be 8am-5pm Pacific will consider someone on eastern time zone as well.
Must be 100% comfortable looking at Non-clinical studies (Animal Data).
Please submit test scores for Word and PowerPoint. Candidate should be proficient in both.
Experience with Smartsheet's and Veeva would be nice to have exposure too although not 100% necessary.
This company 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 supporting scientific study report writing and managing 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 facilitate optimization of IND strategies, 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, including tables of varying complexity.
Ability to construct summary data tables from nonclinical reports.
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 ICH guidelines pertaining to submissions, eCTD format, drug development process, regulatory affairs, regulatory compliance, and familiarity with GxP regulations.
Proficient in MS Windows, MS Office, Adobe Acrobat, and familiarity working in data management systems
Strong attention to detail and ability to consistently meet aggressive timelines
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 (Science related - Biology, Chemistry)
3 or more years of experience within the pharmaceutical, biotech or medical device industry, including working on regulatory submissions, nonclinical research/study oversight experience, and/or quality and compliance-related experience

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

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