PSC Software, a division of PSC Biotech, is a leading provider of cutting-edge, cloud-based quality management and regulatory compliance solutions. Our software helps organizations streamline processes, ensure compliance, and improves overall efficiency, delivering exceptional value to our clients. With specialization in meeting the needs of pharmaceutical, medical device, and other highly regulated industries.
At PSC Software, we are passionate about providing innovative software solutions that empower businesses to achieve their full potential.
The Experience
With operations spanning the globe and featuring a multicultural team, PSC Biotech® is passionate about bringing the best and brightest together to form something 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 passions, 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 a 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
We are hiring technical Writers to support our Software Team. The Technical Writer will translate business specifications into user documentation and is responsible for planning, writing, and maintaining systems and user support documentation efforts, including online help screen. This position is familiar with a variety of the field's concepts, practices, and procedures. A wide degree of creativity and latitude is expected.
This is a remote, full-time role based in the Philippines. The initial training period will involve a working schedule compatible with U.S. standard working hours.
- Draft, revise, and review software validation documentation (e.g., validation plan, configuration specification, requirement specification, summary report) using approved templates and guidance.
- Maintain comprehensive knowledge of ACE system functionalities to effectively author, review, and revise validation documentation.
- Assist in drafting data migration documentation (migration plan, migration protocol, migration report).
- Update validation document templates, as necessary.
- Draft/revise SOPs for internal and client use using established formats.
- Support documentation projects in collaboration with key stakeholders.
- Perform basic editing for grammar, formatting, consistency, and controlled-document expectations.
- Follow documentation practices aligned to cGMP and GDP, and maintain standardized, consistent documentation.
- Organize and maintain documentation artifacts for review cycles (version control, comment resolution, file hygiene).
- Leverage Confluence as a documentation platform to author and manage internal onboarding materials for new hires and external customer facing documentation, including FAQs, knowledge base articles for technical support, and customer onboarding content.
- Additional duties and responsibilities may be assigned as necessary.
- Ad-hoc assistance to a variety of projects may be required.
- Additional duties as deemed appropriate by the department head/designee.
- Any additional ad-hoc duties as requested by Management to fulfil business requirements.
Requirements
- Bachelor's Degree in related STEM fields, or equivalent.
- At least 2 years of Technical Writing experience related to software specifications and products.
- Experience with Technical Writing for cGxP systems or facilities, preferably pharmaceuticals.
- Knowledge of FDA Regulations.
- Knowledge and experience with Clinical and Regulatory Affairs documentation in a regulated environment.
- Excellent verbal and written communication skills.
- Strong organizational skills.
- Excellent analytical skills.
Benefits
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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— Sarah J.
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Marketing Manager
★★★★★
Verified
