At Allucent , we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a to Submissions Senior Publisher to join our A-team (hybrid). The Submissions Senior Publishe are responsible for preparation, compilation, and publication of electronic common technical documents (eCTD) and other regulatory submissions for investigational, new, and marketed drugs and devices. The Submissions Sr. Publisher has an increasing level of responsibility and is highly knowledgeable and experienced with complex types of submissions across different regulatory regions and Health Authority communications.
In this role your key tasks will include:
- Manages submission timelines and activities for assigned projects to meet or exceed required deadlines
- Performs the formatting, compilation, and publication of regulatory submissions to meet or exceed sponsor and agency requirements and expectations
- Increases skills, knowledge and experience of increasingly complex documents, applications and submission types, amendments to existing applications for lifecycle management purposes.
- Develops knowledge and experience of submissions across different regulatory regions as corporate needs dictate Learns and keeps abreast of updates to regulatory guidance, law, and best practice related to job functionality.
- Mentors less experienced Publishers and Submissions Specialists
- Assists with development and presentation of internal and sponsor training.
- With increasing knowledge and experience, manages and oversees submission processes.
- May interact with project teams to educate sponsors on technical requirements for submissions.
- With increasing knowledge and experience participates in submissions software evaluation, selection, and validation.
- Assists with or leads development and improvement of internal best practices and standards for regulatory operations activities.
- Interacts with regulatory agency technical counterparts to resolve issues and Participates in interdepartmental communications to assist with compliance with regulations pertaining to eCTD and other submission types.
- Submissions Senior Publisher with direct line reports.
- Provides training to direct reports on current and new regulatory requirements for submissions/
- Actively manages direct reports including development and performance management and Assists with evaluation of line report utilization and capacity.
- Actively participates in and leads staff learning & development within regulatory operations.
- Manages submissions team workload to meet or exceed sponsor deadlines.
- Coaches, mentors, and develops reports on collaborative consulting.
- Submissions Senior Publisher with or without direct line reports.
- Actively supports staff learning & development within the company.
- Provides guidance and advises Consulting Project Leads, and/or Project Teams on submissions requirements.
- Participates in meetings with clients to discuss submissions requirements.
- Provides mentorship to team members o Acts professionally with peers and clients, knows business etiquette.
- Draft and contribute as Subject Matter Expert (SME) in the field of Publishing activities to the evaluation/improvement of processes and procedures within the Quality Management System.
- Assure good communication and relationships with (future) clients Provides regulatory operations input to proposals and bids.
- Actively manages, develops, and strengthens client relationships, drives repeat business.
- Contributes and take part in client evaluations, visits and bid defenses.
To be successful you will possess:
- B.S., M.S., Ph.D., or equivalent degree, in a scientific area preferred, and equivalent combination of relevant experience.
- Strong regulatory knowledge of drug, biolo
