Job Description

This is a remote position.

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 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 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 assurance and operations documents, protocols, preports, and analytical method qualification documentation. 
  
  
• 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 analyze existing technical material for reuse and leveraging of information to include in documentation. 
  
  
• Maintain industry standards, following cGMP and GDP guidelines and protocols. Maintain standardized and consistent documentation practices.
  
  
• Establish and support documentation 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 analysis/investigations/corrective actions/etc.).
  
  
• Assist in editing documentation written by others to verify accuracy, consistency, grammar, and format.
  
  
• Communicate and collaborate with team members and project staff to plan, develop, and produce high-quality communication products in a fast-paced environment.
  
  

Additional duties may be assigned from time to time. 

Requirements

•   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 documentation.
  
  
• Strong technical background and experience. Solid understanding of quality principles, terminology, processes, and concepts.
  
  
• Advanced cGMP knowledge and ability to maintain documentation standards. 
  
  
• Excellent communication skills - verbal and written. Ability to collaborate with cross-functional teams.
  
  
• Excellent attention to detail.
  
  
• Strong organizational skills with the ability to multi-task and manage multiple documentation projects. 
  
  
• Strong analytical and problem-solving skills. Adaptable, proactive learner. 
  

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
  
• Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).
  
• Financial Perks and Discounts
  

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.

#LI-RW1

Job Tags

Similar Jobs