Top 3 Must Have Skill Sets:
Day to Day Responsibilities:
- 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
- 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.
- 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.
PAY RATE : $26-$29/hr on W2
- Initial phone screen/virtual meeting with manager.
- Candidates selected to move forward will have a virtual team interview with coworkers and department management.
"This posting is for Contingent Worker, not an FTE"