Regulatory Writer-California

Company: Kelly
Location: Chino
Posted on: November 20, 2020

Job Description:

Clinical Regulatory Writer - REMOTE

Contract/Project Based

Kelly Services is currently recruiting for several Clinical Regulatory Writers for major Pharmaceutical and Biotechnology consulting company.

Job Overview:

Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process for our clients.  The Regulatory Writer is a major contributor to document authorship for a variety of documents across different service lines. Will be the project lead and authoring contributor for all types of client engagements, while mentoring others in the knowledge of authoring regulatory documents.

Job 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, 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

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

Job Requirements/Training:

Bachelor’s degree in related field preferred

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

Skills & Abilities:

Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques

Strong understanding of the document creation process and of the drug development life cycle

Able to synthesize data across multiple data sources and documents to create summary reports

Expertise to provide subject matter guidance for quality document preparation, document review, accurate comment resolution/incorporation, and document finalization

Ability to own 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

Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making

Pharmaceutical, Biotechnology, Clinical Research industry experience is required

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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