Medical Affairs Software and Software as a Medical Device (SaMD) Lead

 

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 Affairs Software and Software as a Medical Device (SaMD) Lead 

 

The Medical Affairs Software and Software as a Medical Device (SaMD) Lead is responsible for global medical and scientific expertise regarding assigned product portfolio (device or digital) and to engage with R&D. Also responsible for supporting regional Medical Affairs (MA) colleagues and collaborate with marketing and strategy teams related to assigned product portfolio and clinically relevant expertise areas.

 

YOUR TASKS AND RESPONSIBILITIES

 

The primary responsibilities of this role, Medical Affairs Software and Software as a Medical Device (SaMD) Lead, are to:

 

• Consolidates existing medical-scientific expertise & activities between global product experts;
• Co-develops/aligns global medical strategy for the relevant brands;
• 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.

WHO YOU ARE

 

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

• Medical qualification as MD or equivalent (D.O., M.B.B.S, PharmD, etc.), or a Bioscience/Engineering degree with relevant experience in the device area;
• Experience within medical device development;
• 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.

Preferred Qualifications:

• Clinical experience is an advantage;
• Relevant 2-3+ years of industry experience;
• Exposure to artificial intelligence/machine learning applications in Radiology is a plus.

 

Employees can expect to be paid a salary of between $127,421 to $191,131. Additional compensation may include a bonus or commission (if relevant).  Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

 

This posting will be available for application until at least 5-24-24.

 

#LI-US

 

 

 

    YOUR APPLICATION      

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportun