Jobs and Careers

Global Senior Specialist, Publishing - Regulatory Affairs

United Statesfull_timeVerifiedPosted 22 Aug 2024

About the role

The Role

The Regulatory Operations Senior Publishing Specialist is responsible for the planning, creation, and submission of regulatory submissions. In collaboration with the Regulatory Lead, you will plan and prepare high-quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner. The Senior Publishing Specialist provides regulatory operations expertise to cross-functional submission project teams, promoting and bringing excellence in planning, preparation, and delivery of regulatory submissions. You will act as the primary point of contact for daily submissions for major submissions. At Moderna, we act with urgency and behave like owners, reflecting our commitment to delivering transformative medicines to patients.

Here’s What You’ll Do:

Compile, publish, and verify submission dossiers in accordance with international eCTD requirements and regulatory guidelines.
Lead the submission of MAA, INDs, NDAs, BLAs, Master Files, and other regulatory documents.
Work closely with team members to compile documents, review hypertext links, ensure PDFs are submission ready, format tables and graphics, bookmark sections, and proof submissions according to internal standards.
Develop new processes and procedures to enhance efficiency and accuracy during the submission process.
Collaborate with submissions management to build technically valid and high-quality dossiers.
Manage the submission of eCTD sequences through health authority gateways.
Perform quality control (QC) of documents published by other team members to ensure compliance with applicable guidance documents.
Assist with the remediation of Word documents to ensure proper format and compliance.
Mentor and train other team members to increase the quality across the team.
Participate in internal and external audits, maintaining compliance with department systems, e.g., project database, timesheets, training.
Contribute to the development of new publishing services and actively participate in department initiatives and process improvements.
Maintain a strong understanding of applicable regulatory guidelines and ensure the achievement of individual utilization targets.

Here’s What You’ll Bring to the Table:

Bachelor’s degree or equivalent.
At least 5 years of experience as a regulatory Publisher in a pharmaceutical company or CRO.
Experience leading the submission of MAA, INDs, NDAs, BLAs, Master Files, etc., formatted according to international eCTD requirements.
Clinical report and global submission dossier publishing/compilation experience in the pharmaceutical or related industry.
Experience with electronic clinical document publishing standards/formats and global regulatory submission publishing standards/formats (e.g., eCTD, EU CTR).
Working knowledge of publishing tools (e.g., DXC, eCTD Xpress, Veeva), global submission validation tools, Document Management systems, Toolbox, HA electronic submission gateways, IRIS, CTIS, MS Office tools.
Familiarity with global Clinical and Regulatory HA requirements (e.g., FDA, ICH, EMA, MENA region, CH, MHRA).
Strong interpersonal and project management skills, with experience working in a complex, global cross-functional organization.
Highly motivated, organized, and detail-oriented team player.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Ability to readily adjust to change in a fast-paced environment and multitask.
Positive attitude and ability to effectively collaborate with peers, stakeholders, and cross-functional colleagues in a global team environment.
Strong technical skills.
Strong communication and business writing skills.
Fluency in English.
This role is based in our new LEED-certified HQ in Cambridge, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.