R&D Technician I
Key responsibilities Include:
- Preparing Nonclinical Documents for regulatory submission
- Technical expertise
- Process protocols, reports, submission documents and other documents, as assigned and on a timely basis
- In-depth knowledge of MS Word
- Ensure high quality compilation and QC of Pathology, Toxicology, Genetic Toxicology, and other reports within specified timelines.
- Create Virtual Document of report and M4 of Regulatory Submissions to assist in quick compilation completion.
- Prepare early drafts of Toxicology Reports, Toxicology sections of INDs and NDAs, Toxicology Tabulations, Abstracts, IND Annual Reports.
- Ensure issuance and correct distribution of all protocols and amendments
- Knowledge of where reports and submission documents fit into regulatory submissions
- Coordinates and assists with preparation of JNDA inventories and GLP Compliance Statements
- Key responsibility is drafting and quality control checks of all assigned document content within defined standards (non-scientific)
- Accountable for Quality Control checks of regulatory documents, etc. for consistency and errors per process
- Creates and QCs Toxicology sections of submission planners for Regulatory submissions
- Accountable for Quality Control checks of Regulatory submissions in eCTD Express
- Actively maintain timelines for reports and submissions by tracking timelines for submission documents, and reports and their components. Works proactively with authors and project reps to meet deadlines.
- Produce finished documents in a timely and organized manner
- Provide support and help ensure user testing is conducted for system upgrades
- Maintains document and submission tracking for all documents
- Routinely engages management for issue and timeline status, quality and/or content questions
- Proven ability to excel in a high paced and demanding environment
- Experienced and facile with computer systems and software
- Ability to work independently while contributing as an effective, collaborative team member
- Resolution oriented - uses reasoning to troubleshoot and provide possible solutions to issues regardless of origin, relentlessly seeks root cause of problems
- Works proactively- must be able to provide services and results on time, accurately and consistent with expectations
- Excellent communication skills-both verbal and written. Ability to communicate complex, technical issues clearly
- Ability to prioritize multiple tasks/projects and apply strong organizational skills
- Detail oriented
- Must possess excellent interpersonal skills
- Catch on quickly
- Demonstrates ability to act as a change agent: timelines, priority shifts, system upgrades and migrations, business process improvements, engages management
- Strong knowledge of scientific terminology
- Proven ability to work with diverse teams Experience with document checking, importation and workflows in electronic submissions systems highly preferred.
- Bachelor of Science Degree required.
- 2+ years experience supporting preparation of submission documents in the pharmaceutical industry required.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled