Technical Writer
Technical Writer
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3-5years
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients success and you can be a part of our team s achievements. Employing a global team of sed professionals and experts that span across strategically located offices in North America Europe Asia and the Middle East we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multicultural team PSC Biotech is pionate about bringing the best and brightest together in an effort to form soing truly special. When you make the decision to join our team you will be offered the ability to feel inspired in your career explore your professional pions and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At PSC Biotech it s about more than just a job it s about your career and your future.
Your Role
- Support all technical writing projects in collaboration with the operations teams.
- Write review and revise quality urance and operations doents protocols preports and ytical od qualification doentation.
- Work closely with quality and manufacturing teams to develop technical specifications for products or systems.
- Determine and plan technical report requirements and ensure through research that the technical report will fulfill the intended use.
- Able to yze existing technical material for reuse and leveraging of information to include in doentation.
- Maintain industry standards following cGMP and GDP guidelines and protocols. Maintain standardized and consistent doentation practices.
- Elish and support doentation practices that reduce review times and deviation by researching errors and inconsistencies in existing records and communicating effectively with appropriate personnel.
- Identify and support process improvement efforts (root cause ysis/investigations/corrective actions/etc.).
- ist in editing doentation written by others to verify accuracy consistency grammar and format.
- Communicate and collaborate with team members and project staff to plan develop and produce highquality communication products in a fastpaced environment.
Requirements
- Must be able to support 8am 5pm U.S. Eastern Standard Time Zone.
- Strong knowledge of FDA regulations and IND (Investigational New Drug) applications.
- 310 years of experience in technical writing preferably in the life sciences industry.
- Proven ability to write clear concise and accurate technical doentation.
- Strong technical background and experience. Solid understanding of quality principles terminology processes and concepts.
- Advanced cGMP knowledge and ability to maintain doentation standards.
- Excellent communication ss verbal and written. Ability to collaborate with crossfunctional teams.
- Excellent attention to detail.
- Strong organizational ss with the ability to multitask and manage multiple doentation projects.
- Strong ytical and problemsolving ss. Adaptable proactive learner.
Benefits
Must be able to support 8am - 5pm U.S. Eastern Standard Time Zone. Strong knowledge of FDA regulations and IND (Investigational New Drug) applications. 3-10 years of experience in technical writing, preferably in the life sciences industry. Proven ability to write clear, concise, and accurate technical doentation. Strong technical background and experience. Solid understanding of quality principles, terminology, processes, and concepts. Advanced cGMP knowledge and ability to maintain doentation standards. Excellent communication ss - verbal and written. Ability to collaborate with cross-functional teams. Excellent attention to detail. Strong organizational ss with the ability to multi-task and manage multiple doentation projects. Strong ytical and problem-solving ss. Adaptable, proactive learner.
Employment Type
Full Time
