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.
• Looking for 2-3 years of regulatory/qaulity experience (ideal), a minumin 1 year of experience.
• Science related Degree

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.

Red Flags:          

• Excessive Absences.
• Lack of training or experience mentioned above.
• Short duration in roles. (1-3 months or less)
• Large gaps in employment without any explanation.
• Not comfortable working remotely or independently.
• Not comfortable with Animal testing data.
• Not a team player.
• Poor written and oral communication skills.
• Lack of interest or experience 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.

PAY RATE : $26-$29/hr on W2

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