Requisition Number: 309257
Employment Type: Contract
Job Id : 309257
Our innovative, biotechnology client is seeking a strong Technical Writer to join their dedicated team in Cambridge.
This position has a great benefit package that includes Medical, Dental and Vision benefits, 401k with company matching, and life insurance for those who qualify.
Responsibilities of the Technical Writer:
- Oversee/help to guide the development of policy related to IT compliance (GxP, SOX, Security)
- Assist in developing and maintaining policy and procedure documentation
- Support operational change control process; provide compliance approvals of project deliverables
- Ensure audit and inspection related findings are completed on time
- Guide the development and maintenance of assessment programs for IT processes, people, and procedure
Requirements of the Technical Writer:
- Bachelor's degree in Computer Science or related technical discipline
- At least 5 years of post-grad work experience
- At least 5 years of pharmaceutical regulatory, audit, and IT compliance experience
- Excellent documentation and communication skills; strong attention to detail
- Solid understanding of IT governance framework: policies and procedures, risk, and compliance
- Writing samples of previously authored policies and procedures documents required
- Deep understanding of regulatory requirements in technologically progressive Biotech, Pharma FDA, or SOX regulated environments
- Demonstrated strong knowledge of FDA, SOX audit processes, and IT quality system validation best practices
- Experience with risk assessment and related tools (GAMP, NIST, ICH Q9)
- Proven people management experience
Keywords: Technical Writer, Policies & Procedures, Standard Operating Procedures, SOP, IT Governance, Biotechnology, Pharmaceutical
Job ID: 309257
About Eliassen Group:
Eliassen Group provides strategic talent solutions to drive our clients’ innovation and business results. Leveraging nearly 30 years of success, our expertise in IT staffing, Agile consulting, creative services, managed services, and life sciences enables us to partner with our clients to execute their business strategy and scale effectively. Headquartered in Reading, MA and with offices from coast to coast, Eliassen Group offers local community presence, deep networks, as well as national reach. For more information, visit http://www.eliassen.com.
Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
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