Medical Device/SaMD Medical Affairs Lead - Molecular Imaging & Nuclear Medicine Devices

Bayer•Indiana Township, PA

16d

About The Position

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. Medical Device/SaMD Medical Affairs Lead - Molecular Imaging & Nuclear Medicine Devices Responsible for global medical and scientific expertise regarding assigned product portfolio and to engage with R&D. Also responsible for supporting regional MA colleagues and collaborate with marketing and strategy teams related to assigned product portfolio and clinically relevant expertise areas.

Requirements

Medical qualification as MD or equivalent (D.O., M.B.B.S, etc.), or a Bioscience/engineering degree with relevant experience in the medical device area
Relevant experience with medical device development in nuclear medicine or molecular imaging
Initial knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing medical devices & SaMD
Medical device experience supporting the development of brand plans, marketing campaigns and related content or other relevant marketing experience
Ability to support the development of studies and build evidence generation plans
Must exhibit the capability to work collaboratively with management and peers to assess, evaluate and implement business strategies aligned with global or appropriate regional activities
Strong communication and interpersonal skills and the ability to drive measurable outcomes with virtual teams
Desire and ability to work in a fast growing, agile business environment
Willing to travel internationally to global meetings and international congresses
Good medical writing skills and ability to analyze safety data
Good communication skills
Fluent in English, both written and spoken

Nice To Haves

Clinical experience is an advantage
2-3+ years of experience with medical device development in nuclear medicine or molecular imaging
Knowledge of related imaging software and processes a plus

Responsibilities

Consolidates existing medical-scientific expertise & activities between global product experts
Co-develops/aligns global medical strategy for the relevant brands
Has deep expertise in the molecular imaging and nuclear medicine space. Has expertise and experience with related imaging systems, tracers, medications, delivery pumps, or clinical experience with related diagnostic imaging or therapeutic delivery
Completes evidence gap identification, publication planning, and opinion leader development
Improves the dialogue, information exchange and alignment between global/regions/countries
Member and medical lead for device development projects/studies within Product Squads
Co-develops, with marketing, the integrated brand strategy
Ongoing lifecycle support for license to market
Co-Leads the risk assessment for devices, provides health risk assessments (HRA) as required
Contribute to the global communication strategy and campaigns, reflecting disease management as applicable to devices or SaMDs
Lead/support aspects of global projects and adapt product offerings to critical industry trends and competitive activity with support from senior MA medical device/SaMD leaders
Contribute to development and execution of congress strategy and global standards development