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Technical Writer II/III

Serán BioScience is searching for an experienced Technical Writer to support the Analytical Development team deliver accuracy and quality to clients within pharmaceutical development. The Technical Writer authors and reviews documents for Analytical Development and ensures GMP standards are implemented and executed. Examples of documents include protocols, reports, test methods, and SOPs. The selected candidate will work closely with Analytical Development managers to ensure that policies and procedures are followed as written and revised when necessary. Excellent communication skills and working industry knowledge are required, as this role will frequently communicate with clients, Project Management, Quality Assurance and other internal teams. Successful candidates will have at least two years of laboratory experience with a focus on document authoring and review, paired with at least three years of experience working within a GMP environment. Those with various educational backgrounds who have acquired the minimum requirements of industry experience are encouraged to apply.


Duties and Responsibilities
  • Write, revise, review, and approve SOPs, validation protocols, validations reports, and test methods
  • Participate in audits and inspections
  • Assist in forecasting and scheduling analytical validations with Project Management and Quality Control Management teams
  • Conduct scientific/technical reviews of analytical validations, reports, test methods, and SOPs, as needed
  • Authors investigations, CAPA’s Impact Assessments, Risk Assessments, Validation Discrepancy
  • Reports, as required
  • Adheres to consistent and predictable in-person attendance
  • Responsibilities may increase in scope to align with company initiatives  
  • All other duties as assigned


Required Skills and Abilities
  • Excellent verbal and written communication skills
  • Excellent interpersonal and leadership skills
  • Excellent organizational skills and attention to detail
  • Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
  • Excellent time management skills with a proven ability to meet deadlines and motivate teams
  • Demonstrates the ability to collaborate and work in cross-functional teams
  • Follow detailed written and oral instructions
  • Multitasks and adjusts priorities in a fast-paced environment, while maintaining focus and managing disruption and/or unexpected needs
  • Accepts feedback from a variety of sources and constructively manages conflict
  • Proficient with Microsoft Office Suite or related software


Education and Experience
  • Bachelor’s degree in chemistry, physics, engineering, or related scientific discipline
  • Requires 3 years of GMP experience
  • At least 2 years of GMP laboratory experience; heavy focus on document authoring and review


Physical Requirements
  • Prolonged periods of sitting at a desk and working on a computer
  • Must be able to lift up to 25 pounds at times


Compensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.


Benefits Summary:

Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.

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What You Should Know About Technical Writer II/III, Serán Bioscience

At Serán BioScience, we're on the hunt for a talented Technical Writer II/III to join our dynamic Analytical Development team in beautiful Bend, Oregon. If you have a knack for transforming complex scientific concepts into clear, concise documents, this could be the perfect role for you! As a Technical Writer, you’ll be at the forefront of ensuring we deliver the highest quality documentation that adheres to GMP standards. Your primary duties will include writing, reviewing, and approving essential documents such as SOPs, validation protocols, and testing methods. You’ll be collaborating closely with managers and various teams, so excellent communication skills and the ability to work well with others are a must. If you have at least three years of GMP experience and two years of hands-on laboratory experience focused on document authoring and review, you'll fit right in. We value diverse educational backgrounds; if you hold a degree in a relevant scientific field and have the industry experience to match, we’re eager to see your application! Excellent time management, attention to detail, and the ability to multitask in a fast-paced environment will help you succeed in this role. Join us at Serán BioScience, where excellent benefits like generous paid time off, health plans, and an engaging company culture await you. We look forward to welcoming you into our team!

Frequently Asked Questions (FAQs) for Technical Writer II/III Role at Serán Bioscience
What responsibilities does a Technical Writer II/III at Serán BioScience have?

As a Technical Writer II/III at Serán BioScience, your primary responsibilities will involve authoring and reviewing critical documentation such as SOPs, validation protocols, and analytical reports. You'll be actively involved in ensuring that all documents adhere to rigorous GMP standards while collaborating with managers and internal teams to maintain consistency in policies and procedures. Additionally, you'll participate in audits and potentially assist in the scheduling of analytical validations.

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What are the qualifications needed for a Technical Writer II/III at Serán BioScience?

To qualify for the Technical Writer II/III position at Serán BioScience, you should have a bachelor's degree in a scientific discipline like chemistry, physics, or engineering. The role requires a minimum of three years of GMP experience and at least two years of laboratory experience with a strong emphasis on document authoring and review. Proficiency in Microsoft Office Suite and exceptional writing and communication skills are also essential for success in this role.

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What is the work environment like for a Technical Writer II/III at Serán BioScience?

The work environment at Serán BioScience is collaborative and fast-paced, making it ideal for those who thrive on teamwork. You will often engage with the Analytical Development, Project Management, and Quality Assurance teams, contributing to a culture of open communication and shared goals. Located in Bend, Oregon, you can expect a pleasant outdoor atmosphere that complements a productive work experience.

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How does Serán BioScience support the professional growth of its Technical Writers?

Serán BioScience is committed to the professional growth of its employees, including Technical Writers II/III. You will have opportunities to participate in ongoing training and development programs relevant to the pharmaceutical industry. Additionally, regular feedback and project collaboration with cross-functional teams will allow you to sharpen your skills and expand your knowledge within a supportive community.

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What benefits does Serán BioScience offer for the Technical Writer II/III position?

Serán BioScience offers a comprehensive benefits package for its Technical Writer II/III position. Employees enjoy over four weeks of paid time off annually, employer contributions to retirement plans after 90 days, and various health insurance options. Additional benefits include coverage for basic life and long-term disability insurance, an Employee Assistance Program, and even pet insurance to ensure the wellbeing of our employees and their families.

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Common Interview Questions for Technical Writer II/III
Can you describe your experience with document authoring and review in a GMP setting?

In preparing for your interview, consider sharing specific examples of documents you’ve authored or reviewed, highlighting your attention to detail and adherence to GMP standards. Discuss the types of documents you’ve worked on and any challenges you faced during the review process, emphasizing how you resolved them effectively.

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How do you manage tight deadlines when producing technical documents?

When asked about managing tight deadlines, emphasize your time management skills and provide specific strategies you use, such as prioritizing tasks, breaking projects into manageable phases, and collaborating with team members to ensure efficiency. Share a real-life example where you successfully met a tight deadline.

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Give an example of a complex technical concept you had to explain in your writing.

For this question, prepare to discuss a complex concept you translated into reader-friendly language. Detail your process, how you identified your audience's needs, and the steps you took to make the information accessible without sacrificing accuracy.

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How do you ensure accuracy and compliance in the documents you produce?

In your response, highlight your approach to ensuring accuracy, which may include rigorous review processes, cross-checking with established protocols, and soliciting feedback from peers. Stress the importance of continuous learning to stay updated with industry regulations.

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What strategies do you use to collaborate effectively with cross-functional teams?

Discuss your interpersonal skills and how you foster open communication, set clear expectations, and use collaboration tools effectively. Share specific instances where your collaboration positively impacted project outcomes.

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What role do you think a Technical Writer plays in a pharmaceutical development team?

Emphasize the importance of a Technical Writer in facilitating clear communication and ensuring that critical information is documented accurately. Explain how your role can impact project timelines and compliance with industry regulations by providing well-prepared documentation.

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How do you handle feedback on your writing from colleagues or supervisors?

In your answer, illustrate your openness to constructive criticism and your approach to incorporating feedback. Mention how you view feedback as an opportunity for growth and how you manage discussions to ensure clarity of expectations.

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Describe your experience with audits and inspections related to document review.

Detail your past experiences participating in audits or inspections. Discuss how you prepared for these events, your role in ensuring compliance during the audit process, and any specific instances where your documentation played a critical role.

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What tools or software do you prefer for technical writing, and why?

Share your familiarity with tools like Microsoft Word, Adobe Acrobat, or any specialized software relevant to technical writing. Discuss how these tools enhance your efficiency and allow for collaboration, version control, or compliance checks.

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How do you stay updated with changes in GMP regulations and standards?

To answer this question, convey your dedication to professional development. Mention resources you utilize, such as training programs, industry publications, and connections within the professional community, demonstrating your commitment to staying informed.

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At Serán, we utilize a science-first methodology and cutting-edge technologies to enable our healthcare customers to discover and develop innovative medicines that improve patient health.

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EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
December 3, 2024

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