Regulatory Publishing Specialist
- Employer
- ICON Strategic Solutions
- Location
- Belgium, Bulgaria, Homeworking
- Salary
- Competitive
- Start date
- 2 Aug 2024
- Closing date
- 31 Aug 2024
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
What you will be doing:
- Serves as a subject matter expert in clinical document preparation and document management system processes and procedures, which include compilation of granular clinical study reports and other regulatory documents
- Performs document formatting reviews and remediation to ensure compliance with style and submission-readiness requirements
- May act as a liaison with functional area teams to coordinate document finalization and assist in developing clinical submission content/document plans
- Serves as a technical expert for teams regarding the regulatory EDMS and regulatory publishing/submission-readiness requirements
- Acts as a liaison with functional area teams to coordinate appendices collection and document finalization
You are:
- Bachelor's degree
- 2 years of relevant experience in regulatory publishing
- Working knowledge of the requirements of report-level publishing and virtual document creation preferred
- Good working knowledge of Microsoft Office and Adobe Acrobat
- Basic knowledge of electronic regulatory submissions and records management (e.g. ICH E6, CFR 21 Part 11)
- Strong written and oral communication skills
- Strong attention to detail
- Strong project management skills
- Basic ability in electronic document creation, management, and finalization
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Company
As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond.
ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world’s leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact.
Why choose a career with ICON Strategic Solutions?
Meaningful Work: You’ll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives.
Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally.
Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently.
Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization.
Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.
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