Associate Research Operations. Biopharma - Remote (JP9452)
Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Associate Research Operations. Biopharma - Remote (JP9452) Location: Thousand Oaks, CA. (Remote, PST) Employment Type: Contract Business Unit: R&D Operations Duration: Initial 6 months with likely extension(s) Rate: $25-30/Hr DOE Posting Date: 11/29/2021 Target Start Date: 1/3/2021
3 Key Consulting is hiring a Research Associate Operations for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description: Must be 100% comfortable looking at Non-clinical studies (Animal Data). Candidate should be proficient in Word and PowerPoint (test scores may be required) Experience with Smartsheet's and Veeva would be nice to have exposure too although not 100% necessary.
The 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.
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
Bachelor's Degree (Science related - Biology, Chemistry)
1 year of science- or quality compliance-related experience within the pharmaceutical, biotech or medical device industry
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
Why is the Position Open? Supplement additional workload on team.
Top Must Have Skills:
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 to 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.
Employee Value Proposition: This group is interested in the growth and development of their team members. Candidates that are seeking career growth and opportunity within Biotech/pharma industry would do well here. They would have hands on experience in the pipeline of getting lifesaving drugs to patients as this role directly deals with documentation required for FDA approvals.
Red Flags: Excessive Absences. Lack of training or experience. Short duration in roles. (Any contract position should be clearly stated role was contract) Job hoppers without any sensible movement or growth. Large gaps in employment without any explanation. Not comfortable with Animal testing data. No interest in Career development or building No interest in writing or editing.
Interview process: Initial phone screen/virtual meeting with manager.
Candidates selected to move forward will have a virtual team interview with coworkers and department management.
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.