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1+ months

Principal Regulatory Writer - Clinical Focus

Kelly Services
Princeton, NJ 08544
Kelly Science & Clinical is currently seeking **Principal Regulatory Writers** for a long-term engagement with one of our Global regulatory, science, and solutions clients


*****These roles are fully remote*****


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


We are currently looking for experienced Principal Regulatory Writers who have authored clinical documents such as Module 2 documents, investigator brochures, CSRs, Protocols, and clinical sections of submission documents.


**Job Overview:**

Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process for our clients.

The Principal Regulatory Writer (PRW) is a major contributor to document authorship for a variety of documents across different service lines. The PRW will be the project leader and authoring contributor for all types of client engagements, while mentoring others in the knowledge of authoring regulatory documents.


**Responsibilities:**

Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents

Take ownership of entire deliverable (e.g., CMC section [SD1]) 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

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 company 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

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


**Education, Experience, Training, and Knowledge:**

Bachelors degree (minimum)

7+ years of regulatory writing experience with nonclinical, 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)

Strong understanding of the document creation process and of the drug development lifecycle


**Skills & Abilities:**

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 [SD4] (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) [SD5] , 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


**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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-10-15 Expires: 2021-12-18

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Principal Regulatory Writer - Clinical Focus

Kelly Services
Princeton, NJ 08544

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