Junior Scientific Technical Writer
About The Position
The Junior Technical Writer supports the Senior Scientific Technical Writer with the preparation of Batch Records, Standard Operating Procedures (SOPs), protocols, and other GMP documents for the manufacturing department. Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company – where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow’s values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world – providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need. Harrow’s ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including: An expanding Retina Portfolio including IHEEZO®, TRIESENCE®, BYOOVIZTM, and OPUVIZTM A broad Dry Eye Disease product line, led by VEVYE® and bolstered by well-known adjacent ocular surface disease products such as FLAREX® and FRESHKOTE® A peri-operative Surgical product line, led by TRIESENCE®, and BYQLOVITM A Rare and Specialty product line, which includes various high-need and utility products such as ILEVRO®, NATACYN®, and VERKAZIA® A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01
Requirements
- 1-2 years' experience creating documents in a cGMP regulated environment, preferably in a pharmaceutical manufacturing facility.
- Strong organizing and writing skills.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Excellent written and verbal communication skills.
- Ability to work independently and as part of a team, self-motivated, adaptable, and positive attitude.
- Can handle frequent change to priorities and pivot as needed
- Attentiveness to detail
- Understands when it’s appropriate to raise issues to management
Nice To Haves
- Bachelor's degree preferred, (Science degree preferred).
- Experience with electronic Quality Management systems and/or electronic batch record systems a plus
Responsibilities
- Create, revise, and obsolete GMP documents as assigned.
- Learn MasterControl electronic batch record (eBR) system to support changes to eBRs as assigned.
- Gather information through collaboration with subject matter experts to ensure technical accuracy of content
- Understand the level of instruction required for the intended audience
- Ensure documents comply with current Imprimis and/or industry standards, formats and templates.
- Ensure correct spelling, grammar and punctuation.
- Facilitate documents from initiation to closure through the change control process in Veeva.
- Communicate effectively and accurately with the Senior Scientific Technical Writer, internal customers and management to ensure that timelines and objectives are achieved.
- Support compliance projects
- Manage multiple projects simultaneously
- Willing and able to follow sterile gowning procedures to enter the controlled production areas as necessary
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
