CAREER PORTAL
Clinical & Regulatory Research Tech Writer
Category: Life Science
Employment Type: Contract
Reference: BH-387974
Clinical & Regulatory Research Tech Writer
needed for a contract opportunity with Yoh Scientific’s client located in Swiftwater, PA.
This position will be providing cross-functional support as a subject matter expert (SME) to author key documents to begin clinical testing activities. The ideal candidate will have experience in Clinical Research
and have a strong understanding of Good Documentation Practices(GDP) and industry standards. This role is part of a major pharmaceutical company
and requires a Bachelor’s in Life Science. Schedule is full-time M-F (7am-8am start time, 8 hour shift)
and may require flexibility to work some evenings and overtime due to projects.
Key Responsibilities:
- Contribute to the authoring and lifecycle management of key documents to support external clinical testing, including Analytical Test Plans, Lab Specifications and Lab Manuals, and Operating Guidelines.
- Collaborate with laboratory subject matter experts (SMEs) to ensure content accuracy, clarity and scientific integrity.
- Coordinate with Immunoleads to author Sample Request Memos for investigation, development, qualification and validation of external test procedures. This includes interfacing with clinical data managers and clinical biostatistics to bring together information of sample volume and consent with the key immuno readouts to select the proper samples.
- Manage document lifecycle within electronic document management systems (EDMS).
- Ensure compliance with FDA, EMA, ICH, and other regulatory guidelines.
- Be a part of a Global organization and interact with groups across multiple time zones.
Qualifications:
- 2–5 years of experience in documentation or medical writing within the pharmaceutical, biotech, or medical device industry.
- Strong understanding of regulatory requirements (FDA, EMA, ICH).
- Understanding of GXP practices and procedures required.
- Detail oriented with strong verbal and written communication, organizational and time management skills required.
- Highly proficient with MS Word.
- Prior experience with EDMS and associated templates desirable.
- Document coordinator experience a plus.
- Bachelor's in Life Sciences, Nursing or Technical Writing, Masters' in Life Science or related field preferred.
Estimated Min Rate: $40.00
Estimated Max Rate: $45.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Posted on 08-18-2025
Clinical & Regulatory Research Tech Writer
Life Science
Contract