A research-driven biopharmaceutical powerhouse focused on developing treatments for complex, hard-to-cure diseases. This esteemed company has brought 32 groundbreaking products to market, including Humira and Lupron, making a significant global impact. If you're ready to make your mark in the field and contribute to the future of innovative therapies, this is the opportunity for you!
location: Somerville, New Jersey
job type: Contract
salary: $60 - 69 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- The Technical Writer III is responsible for the development, creation, and revision of controlled documentation in accordance with Company policies and procedures, current GMP, 21CFR820, ISO 13485 and AATB Standards.
- Establishes partnerships and works with Change Control, Quality Engineer team members, and other cross functional managers/supervisors and development engineers/teams to ensure that controlled documents being revised contain the correct information per process/product specifications.
qualifications:
Required Qualifications:
- BA/BS: Science, Communications, Engineering, English
- 3-5 years technical writing experience in the medical device, biotechnology or pharmaceutical industry
- In-depth knowledge of MS Word including use of tables, headers/footers, and review capabilities
- In depth knowledge of EDMS Systems (e.g. Veeva Vault)
- Expert grammatical competency and writing skills
- Basic knowledge of FDA, GXP, 21CFR820, ISO 13485 and AATB requirements and industry best practices.
- Project Management Capabilities
skills: MS-WORD, MS-EXCEL, MS-Powerpoint, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
