Global Director of Science and Regulatory

For the past 25 years Klick Health has helped life science clients bring their groundbreaking ideas to market. We’ve also spent that time creating an ecosystem for talented and empathetic individuals to chase their passions while creating long-lasting friendships in the process. What does that mean for you? Well, we grow a lot—like every year for 25 years and counting. And as we evolve and scale, so does our global reach. With that in mind, Klick Health is opening offices in key global markets, and hiring people from those markets who value the health of their communities.

**Please send your resume in English.**

**The Science & Regulatory team is part of the Klick Medical group and is responsible for ensuring content quality and scientific/medical accuracy, while providing regulatory expertise, and managing everything in the wonderful world of promotional review. We’ve got a kick-ass team that does amazing, meaningful work in a dynamic, team-based environment. Klick’s goal is to shape the future of health, and we get to be a big part of that mission. Our business is growing quickly, and it’s time to add a new team member. That’s where you come in.**

**The SciReg team is looking for a seasoned leader in Promotional Regulatory Affairs to propel our tremendous growth from a full service agency/commercialization partner to full service global partner in healthcare. In this role, you will be building a team to support our global client relationships across pharmaceuticals, medical devices, and biologics.**

**Responsibilities**:

- **Client and promotional review-relationships**:

- Builds and oversees the relationship with marketing clients and promotional review committee members to coordinate successful launches, optimize processes, and deliver efficient submission strategies
- Works closely with client and promotional review partners to understand and capitalize on trends in marketing and promotional review
- Participates in review meetings for promotional and non-promotional approval processes, and coordinates with regional/local regulatory bodies
- **
Regulatory**:

- Prepares/reviews submissions for promotional review in accordance with client requirements
- Provides expert regulatory review direction for globally-, regionally-, and oversight of locally-developed promotional and non-promotional materials;
- Provides APAC regulatory expertise for cross-functional teams and communicate regulatory requirements to ensure optimal execution, including identifying and assessing regulatory risks
- Maintains awareness of current trends in Regulatory Affairs to bring innovative approaches to the cross-functional team and clients
- Ensures compliance with client and regulatory body pharmacovigilance requirements
- **
Medical and Editing**:

- Assesses adequacy of clinical evidence provided to support proposed claims, and consistency of proposed claims with approved labeling documents or other relevant medical sources
- Provides oversight for teams of editors, following editorial/proof-reading best practices
- **
Process/Efficiency**:

- Develops of SOPS, tools, reports, templates, business processes, training and communications in accordance with client and promotional review committee needs
- Possesses excellent organizational, computer, and documentation skills and an ability to prioritize effectively
- Identifies opportunities and creates mechanisms for improving the promotional and non-promotional review process, utilizing a data-centric approach
- Provides comprehensive expertise and oversight throughout a project life-cycle, from concept to delivery/launch, of promotional and non-promotional campaigns
- **
Soft Skills, Collaboration, and People Management**:

- Grows a team to provide high quality regulatory, medical, and editorial support, in compliance with client requirements to enable business growth
- Demonstrates an entrepreneurial spirit, and strategic and analytical thinking
- Is comfortable working under pressure and ambiguity; has the ability to work effectively in a cross-functional team environment
- Manages internal team to ensure the review processes and standards are upheld and global, regional, and local requirements are assessed and addressed
- Collaborates and communicates between global/regional and local leadership. Has the ability to lead and work well in multidisciplinary/multicultural teams

**Requirements**:

- Degree in a science
- or regulatory-related field, with pharmaceutical/medical device/biologics experience, or equivalent experience
- 8+ years experience in pharma industry, with 5 years of advertising and promotion experience preferred
- Experience building and growing teams and client relationships
- Knowledge and understanding of EMEA and Local Markets, regulatory expertise in advertising and promotion for prescription and/or non-prescription products
- Experience in international review and approval process of pharmaceutical/biologics/medical device promotion