Technical Writer/Document Management

Prepare analytical, formulation, stability, manufacturing, operating procedures and other technical and GMP related documentation.

- Use Electronic Document Management System (GDMS) for the preparation and maintenance of electronic (documents) records.
- Administer the electronic document review and approval process.
- All work is to be done in a compliant manner according to SOP guidelines and cGMPs.
- Review for accuracy, readability and format ensuring that all documents are in compliance with company policies/guidelines and meet the required timelines.
- Maintain hard copy files, electronic data, and records for Consumer Global R&D and enter data in electronic database for data tracking purposes.
- Responsible for performing essential functions of record operations, such as indexing, filing, retrieving, distributing (via copying or check-out), and ensuring the integrity of records housed in the PR&D site repository.
- Participate in various operations, such as annual file review, relocation of records, inventory control, etc., as required.
- Assist with other clerical activities as required.

EDUCATION/EXPERIENCE:

- BS Degree in Scientific field plus 1-3 years of direct experience required/preferred (Pharma experience a plus).

SKILLS:

- Advanced knowledge of Microsoft tool suite (Word, Excel, PowerPoint, and Access) is required.
- Excellent writing, communication, and organizational skills, and attention to detail.
- Technical writing experience in the pharmaceutical industry is preferred.
- Candidate should have the following personality traits if possible: Integrity, strong work ethic and be able to work with a team.