Medical Writer (Clinical)
The O'Connor Group
1 month ago
Job type: Full-time
Hiring from: USA Only
Category: Medical / Health
Our Client is a world class consulting organization in Regulatory Affairs Submittals.
Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process for our clients. The Associate Principal Regulatory Writer (APRW) is a major contributor to document authorship for a variety of documents across different service lines. The APRW will be the project leader and authoring contributor for all types of client engagements, while mentoring others in the knowledge of authoring regulatory documents.
- 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, and actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents)
- Author documents per client specifications, templates, style guides, and other guidance documents
- Author documents per regulatory authority guidelines and requirements
- Act as client advisor, working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result
- Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work
- Manage budget for a low complexity project, including all contributors (writers, editors)
- 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
- Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements
Education, Experience, Training, and Knowledge:
- Bachelor’s degree
- 8+ years of regulatory writing experience with nonclinical, clinical, CMC or pharmacovigilance related documentation
- Understand regulatory requirements for different phases of development and different regulatory pathways
- Knowledge of global health authority requirements
- Experience in the development of submission-level documents
All your information will be kept confidential according to EEO guidelines.
Before you apply, please check if any restrictions apply in terms of time zone or country.
This job has a geo-restriction in place: USA Only.
Please mention that you come from Remotive when applying for this job.
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