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Director of Science and Regulatory
Klick, Germany
Experience
1 Year
Salary
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
As mentioned in job details
Total Vacancies
1 Job
Posted on
Feb 17, 2023
Last Date
Mar 17, 2023
Location(s)
Job Description
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 lotlike 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 culturewe 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.
Please send your resume in English.
The Science amp; 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 glo
Job Specification
Klick
Information Technology and Services - Kingston, Canada