Science and Regulatory Director
For the past 26 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.
Our philosophy is to invest in people early and to develop future leaders at all levels. It’s what’s put us on multiple Top 10 lists for workplace culture—we give people the necessary guidance and room to innovate. We know that career paths are seldom simple and straightforward, but we see that as an asset. If you feel like you'd be a good fit, please apply and join us in doing health differently.
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
- 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
- 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
- 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
- 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
- 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
Regulatory
Medical and Editing
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 APAC 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
- Proven people management skills
- Fluent in English, proficiency in Mandarin or Japanese as an asset
- Knowledge of Pharmacovigilance requirements
- Ability to relocate to Singapore and travel internationally
Klick is consciously creating a culture where everyone can thrive and grow in their careers. We believe that our best work comes from our diverse backgrounds, perspectives, and skills. We strongly encourage members of historically underrepresented communities to apply, including Black people, Indigenous peoples, and other people of colour, people with disabilities, people from gender and sexually diverse communities and people with intersectional identities.
We’re also committed to developing an inclusive, barrier-free recruitment process and work environment. Should you require any accommodation, please contact us at careers@klick.com and we will work with you to meet your accessibility needs and ensure you have a positive experience.