New

Technical Writer - I

Equiliem
United States, Florida, Orlando
Jan 30, 2025
RESPONSIBILITIES: Directly participate in new product development projects, with the primary responsibility being the creation of high-quality written content to support Scientific Affairs tasks. Conduct meetings, communicate, and implement an operational plan for completing Scientific Affairs tasks/milestones Monitor progress and performance against the project plan. Set priorities, allocates tasks and coordinates with Scientific Affairs team to meet project targets and milestones. Daily interaction with technical documentation, with documentation tasks to be performed with quantitated high-throughput and attention to detail. Required to proofread, prepare, create, review, edit, and update Quality and Technical Documents including, but not limited to: SOPs, Design Control Documentation (Customer Requirements and Product Requirements,), State-of-the-Art, Clinical Performance, Scientific Validity Protocols and Reports. Also assists product labeling team draft Explanation of Test. Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing, and testing activities. Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships. Learn complex concepts and communicate the information in a way that is engaging and understood by users. Mange and update revision to technical literature. Maintain a comprehensive library of technical terminology and documentation. Carries out duties in compliance with established business policies. Adapt rapidly to a changing industry and be able to adjust responsibilities, time and objectives accordingly. Perform other duties & projects as assigned. MINIMUM QUALIFICATIONS \| EDUCATION/EXPERIENCE: Bachelor's degree from an accredited university. Proven experience in technical writing position. Minimum of 2 years of technical writing experience in a GMP/Biotech/Pharma/Regulated Industry PREFERRED QUALIFICATIONS: Demonstrated success in Technical Writing in the GMP / Biotech / Pharma / Medical Device/Regulated Industry Very strong written and verbal communication skills Strong experience owning and end-to-end documentation creating process Strong skills in Microsoft Office, especially in Word, Excel and Power Point Experience in Quality Assurance/Regulatory requirements in medical device/ pharma/ biotech industry COMPETENCIES: Very strong attention to detail Must be coachable and must follow written and verbal direction Must be able to productively generate quality documentation to meet program timelines