Location: Buena, NJ
Provide support in facilitating R&D operations from Buena and Estonia into quality control and manufacturing.
Reporting Relationships: Individual Contributor
- Work across multiple Teligent sites (Estonia and Canada).
- Assign document numbers, make logbook entries, organize documents.
- Route documents for approval.
- Prepare document binders, make entries in database for traceability.
- Scan documents and prepare for offsite storage. Retrieve documents from offsite storage.
- Maintain logbook for documentation number issuance.
- Make photocopies of documents for regulatory filing.
- Ensure timely delivery of documents for ANDA submission
- Prepare and review SOPs, as required
- Keep supervisor informed.
- Seek Dept Head’s guidance on resolution of complex issues
- Assume other activities and responsibilities from time to time as directed.
- BS in Chemistry or related discipline with at least 1-2 years of document clerk/ technical writing experience in the Pharmaceutical Industry.
- Exceptional knowledge of using Microsoft office and or other related software used in technical writing/document management.
- Preferred knowledge of ANDA documentation requirement and technical writing.
- Strong problem-solving skills.
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team members and company priorities
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Adheres to Teligent’s standards of business conduct.
- Good written and oral communications. Demonstrated ability to work on multiple projects and meet timelines
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs