We are seeking an experienced Regulatory Writer with a strong background in writing protocols, clinical study reports (CSRs), briefing books, informed consent forms (ICFs), and CTD Module 2 documents. This expertise is critical to the role. The successful candidate will play a key role in preparing high-quality regulatory documentation to support clinical and regulatory submissions, ensuring compliance with global regulatory requirements.
This is a client-facing position that requires exceptional communication skills and the ability to present professionally. The ideal candidate will have a PhD, 5-10 years of regulatory writing experience, and experience with lay summaries (plain language summaries) is highly desirable. The Regulatory Writer will collaborate with internal and external teams, lead regulatory writing projects, and provide strategic guidance on regulatory documentation best practices.
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
- Lead a project team, actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents)
- Serve as liaison and subject matter expert internally and for clients, guiding and advising them on strategies and best practices for achieving approval/agreement from regulatory authorities for all document types that the organization writes
- Author documents per client specifications, templates, style guides, and other guidance documents
- Author documents per regulatory authority guidelines and requirements
- Act as client advisor and proactive consultant to collaborate and anticipate the needs of the client based on the relationship and knowledge while looking for new business opportunities
- Take ownership of entire deliverable (e.g. CMC section) that include multiple writers
- Manage budget for all types of projects, liaise with finance and mentor others in fiscal responsibility and outcomes at the project level
- Usher documents through the review process, conduct comment resolutions meetings (CRMs), and successfully lead a project team to consensus
- Maintain collaborative, proactive, and effective communication with both client and internal teams
- Lead project-related meetings and teleconferences and coach others in same
- Provide coaching to junior staff for all documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements
qualifications:
- Candidates must have 5+ years of experience in a clinical regulatory writing capacity
- Experience writing protocols, CSRs, briefing books, ICFs, and CTD module 2.
- Experience writing lay summaries (lay language or plain language summaries).
- 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)
- Strong understanding of the document creation process and of the drug development lifecycle
- Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques
- Able to synthesize data across multiple data sources and documents to create summary reports
- Practice blameless problem solving, effectively managing all crisis communications, managing risks, and realizing business opportunities
- Ability to communicate difficult and complex ideas clearly and effectively to all stakeholders
- 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
- Ability to lead sub-teams for deliverables (e.g., pharmacovigilance documents, transparency & disclosure deliverables) , taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects
- Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making
- Ability to identify potential problems, promptly tackling those problems, particularly in sensitive or high-pressure situations
- Possesses broad experience and technical expertise across more than one therapy area and integrate this knowledge to deliver business successes and actively transfer this knowledge to strengthen the skill base across the organization
skills: CSR, CTD Structure, Regulatory Briefing Documents
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.
