Associate Scientist I

Job Description
Proficiently manage the nonclinical portion of regulatory submissions involving multiple cross-functional subject matter experts. With input from the submission teams and project representatives, this individual establishes and maintains the nonclinical (Module 4) submission content planner, associated documents and timelines in support of development, marketing, and post-marketing regulatory authority applications.
Responsibilities:
Oversee nonclinical submission content, ensuring the timely delivery of high-quality dossier components that align with technical specifications outlined by regulatory authorities. These components should facilitate easy navigation and review by regulatory agencies. Serve as a liaison with scientific Subject Matter Experts (SMEs), conveying established submission processes and standards.
Coordinate and manage multiple interrelated activities concurrently for submission projects or various reports. Proactively anticipate obstacles and collaborate with the team to formulate solutions. Facilitate the creation or procurement of submission content deliverables such as summary documents, reports, and literature references.
Conduct thorough quality assessments of published output, ensuring alignment with regulatory standards and health authority guidance. Verify content, including Study Tagging Files and SEND components (where applicable), bookmarks, hyperlinks and tables of content.
Contribute to the development of optimal business processes and standards within the department, ensuring robust stakeholder support to achieve high quality submissions. Play a role in crafting and implementing internal standards for submission documents.
Position accountability/scope:
Regularly engage with the manager to discuss project priorities, timelines, progress and identified challenges.
Manage projects with oversight as necessary.
Provide training and cross-train with other team members to offer additional support as required.