4300 Hacienda Dr Pleasanton, CA 94588
Bayside Solutions is seeking a Technical Writer to be part of our client’ s team in the East Bay Area. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Works closely with cross functional project teams and other technical writers for writing projects and conducts formal review meetings, tracks project status, and resolves any communication barriers
- Facilitates the timely development, change, review and approval of documentation.
- Designs, develops, tests, and maintains documentation for Roche Sequencing Solutions (RSS) within established schedule and budget targets.
- Creates, writes and edits high quality text using corporate and department style guidelines.
- Assists in ancillary services and interdepartmental activities or applications required for publication, preparation, storage and delivery of documentation.
- Participates on teams to drive organizational adoption of new tools and processes for content creation and management.
- Develops and revises Quality System documents, such Guidance Documents, Work Instructions, and Templates to drive consistency and quality of content in user documentation.
- In collaboration with engineering team, develops and revises Engineering documents, such Verification Plans, Test Cases, Test Reports, Work Instructions, and Templates to drive consistency and quality of content in documentation.
- Communicates effectively with interdepartmental teams and external vendors/ customers during activities such as the design transfer and production.
- Maintains established metrics to monitor department activities and performance measures.
Summary of Qualifications:
- Bachelor' s degree in a scientific discipline, business administration, technical writing, or other related technical field required. Master’ s degree preferred.
- Minimum of 5 years’ experience required. The experience relates to the medical device, software, pharmaceutical, or biotechnology industry.
- Knowledge of current US and International regulations as it pertains to documentation (e.g., FDA, ISO, IVDD and 21 CFR Part -11), and control of electronic records preferred.
- Demonstrable record of working on project teams while working on multiple projects.
- Experience with mentoring other technical writers preferred.
- Knowledge of medical device, software, pharmaceutical, or biotechnology industry preferred.