We have a non-clinical Writing Opportunity immediately available. This will be remote, 20 hours per week, and offer a flexible schedule. Hourly Pay.
location: Wayne, Pennsylvania
job type: Contract
salary: $90 - 100 per hour
work hours: 9 to 5
education: Masters
responsibilities:
- Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents
- Ability to lead submission-level sections (e.g., nonclinical section [Module 2.6]), taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects
- Prepare high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process for our clients.
qualifications:
Required :
MS Degree at a minimum
5+ years of non-clinical writing experience consisting of modules 2.4, 2.6, and 4.2
Experience in Pharmacology / Pharmacokinetics
- 5+ years of regulatory writing experience with clinical, non-clinical, CMC or pharmacovigilance related documentation
- Understands regulatory requirements for different phases of development and different regulatory pathways
- Knowledge of global health authority requirements
- Collective experience writing and leading a range of documents in their entirety (e.g. study and submission level, pharmacovigilance)
skills: CMC, CTD Structure, Safety Narrative
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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.
