Sr. Technical Writer

Category:

Life Science

Employment Type:

Contract To Hire

Reference:

BH-375439-1

CONTRACT POSITION - W2

ON-SITE POSITION IN SAN JOSE, CALIFORNIA 95134

HYBRID WORK SCHEDULE

PAY RANGE UP TO $50.00 PER HOUR (DEPENDING ON EXPERIENCE LEVEL)

Technical Writer
needed in San Jose, California 95134
for a long-term contract
opportunity with Yoh's client.

The Big Picture - Top Skills You Should Possess:

• Technical writing
• Standard Operating Procedures (SOP) writing
• Medical devices or pharmaceutical
• R&D
• Design History Files (DHF)
• Regulated industry
• Excellent written and verbal communication skills
• Strong attention to detail and accuracy
• MS Office proficiency

• Responsible for creating and managing documentation for the Research and Development department.
• Work closely with cross-functional teams, including Engineers, Scientists, Regulatory Affairs and Quality Assurance, to ensure accurate and timely documentation is produced.

• Develop and maintain technical documentation that meets organizational standards standard operating procedures, protocols, development plans, development process
• Creates end-user regulatory complaint product labeling.
• Contributes to new product development and design change activities in the areas of labeling design/release, technical writing, development of artwork/images and development.
• Collaborates with cross-functional teams to gather information and ensure documentation is accurate, complete, and consistent.
• Manages the review and approval process for all technical documentation to ensure compliance with regulatory requirements.
• Ensures documentation is up-to date, accurate and accessible to all stakeholders.
• Assists in development and implementation of documentation standards, policies and procedures.
• Provides weekly summary of activities, creates project plans for tasks assigned, prioritizes, and effectively communicate updates to customers.
• Follows Good Document practices (GDP) for all documentation created/reviewed and staying current on all required training.

• Bachelor's degree or Master's in engineering, Science, or a related field.
• At least 5 years of experience in technical writing for medical device or pharmaceutical development process (protocols, development plans, reports)
• Experience in:
• IVD or Pharmaceutical technical writing with R&D
• Design history files (DHF)
• Working in a regulated industry such as FDA or ISO.
• Electronic document management software (Livelink or similar) for tracking and processing document change requests.
• FDA regulatory writings for internal use
• Proficient in documentation tools such as MS Office, Adobe Acrobat and content management systems.
• Excellent written and verbal communication skills with the ability to effectively communicate technical information to a variety of audiences.
• Strong attention to detail and accuracy.
• Ability to work collaboratively in a cross-functional team environment.
• Ability to prioritize and manage multiple projects simultaneously.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs