Recruiting for a Clinical and regulatory research writer to 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 is a highly technical role, requiring the reading and interpretation of clinical trial protocols and translating study endpoints into practical plans for the Late Stage Immunology and/or External testing labs to implement. Essential duties include end-user support for Analytical Testing Plan generation and lifecycle management of electronic documents and coordinate with various departments and platforms to collect and compile information required for those documents, adhering to established timelines for project completion. Experience with medical writing would be advantageous.
Position requires highly organized individual with excellent communication skills and ability to form working relationships with department personnel. Must be highly proficient with EDMS and Master Template and familiar with key clinical documentation generation to support testing activities. Previous experience as a clinical/medical writer or document coordinator a plus.
Key Responsibilities:
- Contribute to the authoring and lifecycle management of key documents to support external clinical testing, including Analytical Test Plans, PPD Central Lab Specifications and Lab Manuals, and Sanofi Operating Guidelines
- Collaborate with Late State Immunology (LSI) laboratory subject matter experts (SMEs) to ensure content accuracy, clarity and scientific integrity.
- Coordinate with Global Immunology (GI) Immunoleads to author Sample Request Memos for investigation, development, qualification and validation of external test procedures. This includes interfacing with PPD, 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.
Experience:
- 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
Technical skills:
- 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.
Education:
- Bachelor's in Life Sciences, Nursing or Technical Writing, Masters' in Life Science or related field preferred
Languages:
English
Estimated Min Rate: $25.00
Estimated Max Rate: $34.00
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.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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