Nonclinical Regulatory Writer - Module 2.7.1 and 2.7.2

Randstad Life Sciences US; Wayne (PA); Remote; USD 60,000 - 80,000; Full time

Job summary

An innovative firm is seeking a skilled Nonclinical Regulatory Writer to join their remote team. In this role, you will leverage your expertise in pharmacology to prepare high-quality documentation for regulatory submissions, focusing on clinical pharmacology and bioanalytical reports. This position offers the opportunity to contribute significantly to the documentation process for critical regulatory modules. Join a forward-thinking company that values your skills and offers competitive pay and benefits, including health insurance and 401K contributions. If you have a passion for regulatory writing and a strong academic background, this is the perfect opportunity for you.

Benefits

Health Insurance

Incentive Programs

401K Contributions

Qualifications

• Experience in writing clinical pharmacology and bioanalytical reports.
• Demonstrated ability to prepare high-quality documentation for regulatory submissions.

Responsibilities

• Prepare documentation for regulatory submissions.
• Write clinical pharmacology and bioanalytical reports for Modules 2.7.1 and 2.7.2.

Skills

Pharmacology

CTD Structure

Education

MS Degree

PhD Degree

Job description

Nonclinical Regulatory Writer - Module 2.7.1 and 2.7.2

Join to apply for the Nonclinical Regulatory Writer - Module 2.7.1 and 2.7.2 role at Randstad Life Sciences US.

Job Summary

40 hours per week, remote Nonclinical Writer with demonstrated experience writing clinical pharmacology and bioanalytical reports for Modules 2.7.1 and 2.7.2 (note: you will not be writing the modules, only the reports that go into them).

Location: Wayne, Pennsylvania

Job type: Contract

Salary: $80 - 90 per hour

Work hours: 9 to 5

Education: Doctorate

Responsibilities

Regulatory Writers prepare high-quality documentation for regulatory submissions to streamline the documentation process for clients. In this role, you will write clinical pharmacology and bioanalytical reports that will be included in Modules 2.7.1 and 2.7.2.

Qualifications

• Required: At least an MS degree.
• Preferred: PhD Degree.

Skills: Pharmacology, CTD Structure.

Additional Information

Equal Opportunity Employer: We welcome applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or veteran status. Reasonable accommodations are available upon request. Pay is commensurate with experience and qualifications. Benefits include health insurance, incentive programs, and 401K contributions. This posting is open for 30 days.