Job Description

Our Policy & Government Affairs team collaborate with government entities and policy organizations at local and national levels. We address legislative and regulatory issues that promote the discovery and development of innovative medicines, vaccines and animal health products while improving and protecting patient access to care.

We are looking for an Associate Director Regulatory Affairs, AI and Hyperautomation (m/f/d) who can join our team as soon as possible. This is a full-time and permanent role.

The Associate Director Regulatory Affairs, AI and Hyperautomation position will be responsible for developing, deploying, and maintaining AI and Power Platform capabilities within the Global Regulatory Affairs and Clinical Safety (GRACS) Organization. The role will encompass business operations, technical development, and organizational management. This role will enable business value using citizen development model techniques to enhance processes that are non-GxP and fall outside the scope of core Regulatory system capabilities. The position requires collaboration with stakeholders across the global landscape and will serve as a liaison between the Business Area and IT organizations to define and apply User Requirements for system build/release activities, ensuring delivery timelines are met.

Your profile:

Bachelor’s degree in Business, Technology (Information Management, Computer Science, Engineering), Analytics, Scientific or relevant business operations discipline is requiredA minimum of 5 years of experience supporting business operations in life sciences, pharmaceutical or related industry are requiredAdvanced expertise in Microsoft Power Platform (Power Apps, Power BI, Power Automate, etc.), Microsoft Copilot, MS, Fabric, Microsoft Dynamics 365, Azure, Dataverse, Microsoft Excel and Microsoft Office Suite strongly preferredAbility to leveraging a LLM to solve a business solution and highlight the process for identifying the necessary Gen AI steps to load data, learn from data, and predict or generate output leveraging the AI solutionsFamiliarity with open source HuggingFace models, vector embedding, chunking strategies, PEFT, RAG, pythonExperience with Content Management system (e.g., Veeva Vault) and Workflow systems (e.g., Appian)Working knowledge of processes, systems and business environment within Regulatory Affairs and / or pharmaceutical settingExcellent communication and presentation skillsDemonstrated ability to network, collaborate, and communicate across cultures, organizational levels and disciplinesGrowth mindsetDetail-oriented and able to manage multiple competing priorities executing project plans with a sense of urgencyExperience working in a cross-functional and collaborative team environmentAbility to lead by influence and work effectively in matrix organizational structuresBroad organizational awareness and knowledge of touch points/interdependenciesDemonstrated Change Management knowledge/experienceExcellent project management, problem solving, and communication skills

Preferred experience and skills:

Familiarity with Business System RequirementsRobotic Process AutomationAbility to leverage API calls – experience familiarity with JSON / Postman / APIs / MicroservicesMS SQL experience (relational database table structures, stored procedure creation, JSON parsing / logging)Object oriented programming, for cases where it makes sense to call external libraries / functions

What we offer

Exciting work in a great team, global projects, international environmentOpportunity to learn and grow professionally within the company globallyHybrid working model, flexible role patternPension and health insurance contributionsInternal reward system plus referral program5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contributionCafeteria for tax free benefits according to your choice (meal vouchers, Lítačka, sport, culture, health, travel, etc.), Multisport CardVodafone, Raiffeisen Bank, Foodora, and Mall.cz discount programsUp-to-date laptop and iPhoneParking in the garage, showers, refreshments, massage chairs, library, music cornerCompetitive salary, incentive pay, and many more

Ready to take up the challenge? Apply now!

Know anybody who might be interested? Refer this job!

Our Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

01/31/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R326137