Hybrid Pharma Technical Writer for SOPs & Regulatory Docs

PSC Biotech; San Diego (CA); On-site; Full time

Job description

Technical Writer job at PSC Biotech. San Diego, CA.

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 skilled 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 multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you decide 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 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 an experienced and motivated Technical Writer whowill play a critical role in supporting the revision and continuous improvement of documents including Standard Operating Procedures (SOPs) for a dynamic and evolving operation. (Hybrid)

• Produce a variety of technical documents.
• Responsible for writing clear, accurate, and compliant standard operating procedures (SOPs) and routine procedures.
• Collaborate with subject matter experts (SMEs) and cross functional teams to gather and verify technical information, ensuring the accuracy and completeness of documentation.
• Conduct thorough reviews and edits of documents to maintain consistency, clarity, and adherence to company standards and industry best practices.
• Manage document version control and maintain an organized document repository to ensure accessibility and traceability.
• Identify opportunities for process improvements and contribute to the development and maintenance of documentation best practices.
• Stay up-to-date with industry regulations and guidelines (e.g., FDA, EMA) to ensure that all documentation meets regulatory requirements and contributes to regulatory submissions.
• Additional requirements as assigned.
  

Requirements

• 3-5 years or more of experience in the pharmaceutical industry.
• Proven experience developing accurate, concise, and compliant, technical documentation including SOPs and routine procedures in the pharmaceutical and engineering industries.
• Strong knowledge of cGMP regulations.Strong understanding of pharmaceutical terminology, processes, and regulatory requirements.
• Engineering background (process engineering, validation engineering, etc.)
  
• Familiarity with software tools such as eSOPS, Condor, and the Microsoft Suite
• Excellent communication skills both verbal and writtenwith the ability to convey complex technical information in a clear and concise manner.
• Attention to detail and a commitment to producing error-free documentation.
• Highly motivated with the ability to work independently, manage multiple projects, and meet deadlines.
  

Benefits

Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Discounted Fitness Rates
• Financial Perks and Discounts
  

Estimated Annual Salary (dependent on experience) $80,000 - $100,000

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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