Digital Lead, Sca and Regulatory International

vor 9 Stunden

Basel, Schweiz Moderna Vollzeit

**T he Role**:
Do you want to join a team that wants to redefine technology for content creation and content management and leverage technology globally for Regulatory international business functions? Did you always think "there must be a better way" when considering technology in content authoring and content management? Do you want to "break the mold" and contribute your skills and talents to the most innovative company in the world? Are you obsessed with making an impact through technology?

Moderna is searching for a Digital Lead to be the owner of our Structured Content Authoring (SCA) platform. You will define and manage the product roadmap in consultation with stakeholders from regulatory, clinical and CMC. By effective communications and inspiration, you are the lead in achieving product vision. You will develop a full understanding of your business partners’ needs and create a priority-based roadmap which you will drive to completion.

In addition, as a digital lead for International Regulatory, you will engage with our international regulatory team to understand their needs and influence our digital strategy for regulatory globally.

**Here’s What You Will Do**:
Build content strategy across different R&D business functions focused on content reuse and componentization

Lead the initiative for a content library and relationships between various Clinical and Regulatory content

Identify digital opportunities to automate the content creation and content collation across R&D

Accelerate the assembly of regulatory submissions for our platforms (e.g., INDs (Investigational New Drug), CTAs (Clinical Trial Application)

Act as digital process steward to align digital tools and processes to support Regulatory international groups

Act as the Digital for Regulatory International liaison in digital international governance committee

Create a Regulatory International roadmap and perform global impact assessment on existing Regulatory roadmaps

Define and maintain product strategy and roadmap in collaboration with the business product owner

Create, maintain and prioritize a product backlog based on the overall strategy and business objectives

Define personas and write user stories to populate the product backlog

**Here’s What You Will Bring to the Table**:
Proven experience with structured content authoring platforms (e.g., RWS Tridion Docs (SDL), Workiva, Authorit, Fonto, Intellinotion)

Working knowledge of Regulatory Information Management Platforms (RIM) - Veeva RIM preferably

Knowledge of and experience in defining R&D content strategy, global regulatory business processes

Deep expertise in content modeling, content strategy across R&D for e.g., IB, IND (Investigational New Drug), CTA (Clinical Trial Application), CSS (Clinical Study Synopsis), Protocol, CCDS (Core Company Data Sheet) and working knowledge of structured content authoring tools

Adept at collaborating across clinical, regulatory, PV globally bridging the gap and connecting dots between various functions experience in Agile Software Development Life Cycle

Ability to practice design thinking and human-centered design to drive innovative solutions

Strong analytical skills, and ability to author user stories from conversations with end-use

Ability to articulate concepts and ideas for different audiences (end users, functional leaders, and digital management)

As a technologist, you know your craft and are fluent in the digital world. You have first-hand knowledge of SaaS (Software as a Service), cloud, and AI (Artificial Intelligence) technologies in a patient-centric environment.

You work independently yet engage proactively with team members, colleagues, and stakeholders to align and drive solutions 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 the team before tasks by collaborating actively with all team members and supporting them.

Minimum 8 years experience working with regulatory platforms for regulatory information management and submission

Bachelor's degree in Biotechnology, Engineering, Computer Science, or equivalent required; masters preferred.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary winter break
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary de

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