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Associate Research Operations / Biopharma (JP7585)

Thousand Oaks, Ca · Biotech/Pharmaceutical
Job Title: Asst. Research Operations / Biopharma- Remote (JP7585)
Location: Thousand Oaks, CA , remote until restrictions removed.  
Employment Type: Contract
Business Unit: R&D Operations
Duration: 3 years with a possibililty to FTE
Job posting date: 8/18/20
Note: Remote until COVID-19 restrictions are lifted 
 
3 Key Consulting is hiring a Research Associate for a consulting engagement with our client, a leading global bio-pharmaceutical company.
 
Job Summary:
The company’s 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 candidate 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 candidate 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. (2-3 years of experience)
  • Experience in reading, understanding, and applying scientific data integrity checks to nonclinical research study reports and regulatory documents. (2-3 years of experience)
  • Time and project management skills.
  • Knowledge of GxP, ICH guidelines, eCTD format, drug development process, regulatory affairs, and regulatory compliance.
  • Proficient in MS Windows 10, 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
  • 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
 

Top Must have Skill Sets:
  • 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
  • Proficient in MS Windows 10, MS Office, Adobe Acrobat, and familiarity working in data management systems
  • Strong attention to detail
  • Excellent written/oral communication skills
 
Day-To-Day Responsibilities:
The prospective candidate will primarily support activities related to scientific study report writing and nonclinical contributions to regulatory submissions. The candidate 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 candidate 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.
 
Red Flags:
Short duration of previous employment, 5+ years of experience.
 
Interview Process:
Phone screen / Skype
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 

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