Digital Regulatory Project Manager

Job Description

• As a Digital Regulatory Project Manager, you will spearhead the execution of digital regulatory projects in support of the Digital roadmap. In this role, you will collaborate with various stakeholders and contributors from regulatory operations, medical writing, and regulatory strategy to advance digital projects for regulatory.
• This role will report to the Principal Project Manager, Clinical Informatics.

• The Digital Regulatory Project Manager acts as the project manager for structured content authoring (SCA) platform deployment:
• Identify project deliverables such as content model and taxonomy, components artifacts.
• Monitor and manage project risks as needed.
• Facilitate governance meetings and status updates.
• Coordinate activities and timelines with external vendors and Digital Centers of Excellence (Cloud operations, cyber security).

• Collect and organize AI project artifacts.
• Work with the AI team to scope and assign the relevant project team members.
• Lead Integration projects which entail a solid understanding of different technical workstreams and dependencies and incorporate them into overall project timelines
• Establish and manage project timelines and project deliverables.
• Work collaboratively across the organization to gain alignment on project goals and deliverables
• Engage with the Computer Systems Validation team to support validation activities (as needed).
• Report on project progress and status.

• 7+ years of experience in digital project management (GxP experience a plus).
• Proven experience with Regulatory processes and platforms (Veeva preferred).
• A tangible record of accomplishment in using Agile approaches in a regulated environment.
• As a technologist, you know your craft and you are fluent in the digital world. You have first-hand knowledge of SaaS (Software as a Service) technology in a GxP environment and a practical understanding of data integrity requirements for systems used in the conduct of clinical trials.
• You have a working knowledge of regulatory business processes in a drug development context.
• You work independently yet engage proactively with team members, colleagues, and stakeholders to get alignment and drive projects forward.
• You do not hesitate to dive in and work alongside your team. You can effectively manage conflicting priorities in a fast-paced environment, and you can navigate ambiguity and lead a team effectively.
• You put your team before tasks by collaborating actively with all team members and supporting them.
• Bachelor's degree in Computer Science, Biotechnology, or equivalent required.

• Our client operates as a developer of messenger RNA therapeutics. The company develops and discovers drugs that produce proteins or antibodies inside patient cells. Its pipeline includes various drug modalities such as prophylactic vaccines, therapeutic vaccines, intratumoral immuno-oncology, localized therapeutics, and liver intracellular. Through its mRNA therapeutics platform, they develop and produce human proteins, antibodies, and novel proteins, which help in preventing, treating, and curing diseases. It also develops therapeutics in the areas of infectious disease, rare liver disease, immuno-oncology, and cardiovascular disease.
• mRNA is now a turning point in the history of science, medicine, technology, and even humankind itself. With this breakthrough discovery, many of the world's biggest and most challenging medical problems are no longer a question of "how?" but merely a question of "when?"
• Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.