Syneos Health is seeking a highly skilled Associate RA to join their team in a remote capacity. This role involves assisting with the preparation of Module 1 documents and regulatory submission documents, including components of Investigational New Drug Applications (INDs) and New Drug Applications (NDAs).
💼About the Role
As an Associate RA, you will play a critical role in supporting the regulatory submission process. Your primary responsibilities will include:
Regulatory Submission Support: Assisting with the preparation of regulatory submission documents, including INDs, NDAs, and other lifecycle maintenance activities.
Document Management: Maintaining and updating regulatory trackers, submission timelines, and status reports.
Research and Analysis: Conducting regulatory research to identify regulatory precedents and support the preparation of orphan drug designation requests.
Communication: Assisting clients, customers, or others with general information and preparing detailed reports and correspondence.
🎓Requirements
Education: Master’s degree in pharmaceutical sciences or a related field.
Experience: Minimum 2 years of experience in a regulatory, quality, or document management support role.
Skills:
Excellent Communication Skills: Ability to communicate effectively with clients, customers, and team members.
Advanced Microsoft Office Skills: Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
Time and Project Management: Ability to manage multiple projects and prioritise tasks effectively.
🌱What We Offer
Career Growth: Opportunities for professional development and growth in a leading biopharmaceutical solutions organisation.
Collaborative Environment: A dynamic and supportive team environment that values diversity and inclusion.
Competitive Benefits: Competitive salary and benefits package, including opportunities for career advancement and professional growth.
🌍Why Choose Syneos Health?
Industry Leader: Opportunity to work with a leading biopharmaceutical solutions organisation that has worked with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorised Products.
Innovative Culture: A company that values innovation, teamwork, and customer satisfaction.
Global Reach: Opportunity to work with a global team across 110 countries and contribute to the development of life-changing therapies.
👉🏻 Interested? Apply Now!
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