Job Description

Senior Manager, Medical Affairs and Clinical Sciences

Job Summary

We are seeking a Senior Manager, Medical Affairs and Clinical Sciences to support product and clinical education and training internally and to external stakeholders, identify and engage patient advocacy groups through collaborative partnerships to enhance educational initiatives and to advise the department on matters of strategic importance. Additionally, this role will lead efforts related to safety related workstreams as well as support clinical operational related activities. This role involves strategic planning and cross functional team leadership projects ensuring that all are executed in a compliant manner. The ideal candidate will have a strong clinical and safety background and patient facing experience, communication skills with a focus on medical devices, and a proven track record leading compliant activities.

Responsibilities (Specific tasks, duties, essential functions of the job)

• Design and implement clinical training curriculums by assessing and analyzing organizational, HCP, and patient advocacy requirements, and by obtaining educational content through participation in cross-functional teams.
• Develop approach, scope, and methodology of training to maximize impact by determining target audience, time, location requirements, and other applicable factors.
• Conduct post-program evaluations of content, remain aware of all changes that may impact training requirements, and implement changes/improvements to training protocols and materials accordingly.
• Lead the efforts of establishing strong relationships with relevant patient advocacy groups and identify gaps in patient education and areas of improvement.
• Work closely with the sales organization to support team’s ability to understand clinical information and identify insights based on field experience
• Provide technical and clinical instruction of a complex nature during various interactions with different internal and external stakeholders including physicians and respiratory therapists
• Be the primary clinical touch point of the department for the sales, patient services, and training groups within the organization
• Create insights-based summary on a regular basis to guide the MA department strategy based on various stakeholder engagement
• Learn the company's products as well as the competitor's products to better educate the product portfolio and be up to date on the literature
• Lead on key compliance related activities such as post-marketing surveillance, HHEs, CER and CEP activities
• Assist clinical operations in portfolio document storage activities, departmental SOP training, and ensure various education and training related materials are stored in easily accessible repositories
• Assist and support in departmental clinical trial activities including oversight and execution of clinical trials in compliance with required processes
• Maintain a positive attitude, exhibit patience, and a can-do approach with internal and external stakeholders
• Ensure robust compliance related regulations on training, education, and HCP interactions are followed.
• Perform various assigned duties as needed based on evolving needs of the department

Knowledge, Skills, and Abilities:

• Strong presentation skills with an ability to perform clinical and product training of various data types to a diverse set of audiences; small or large
• Strategic thinker with a strong focus on education, adherence to compliance guidelines, and operational efficiency
• Ability to interpret scientific data, be current on clinical competitive landscape, and have strong scientific writing skills
• Strong knowledge and understanding of FDA regulations, GCP, and ISO 14155, specific to medical devices
• Must possess excellent verbal and written communication skills and work effectively in a demanding, fast paced environment
• Excellent organizational, relationship building skills, and leadership skills, capable of motivating a matrix team and managing across multiple projects.
• Detail-oriented with strong problem-solving skills and ability to adapt to work collaboratively with different cross functions at a global level
• Demonstrated problem-solving, critical thinking, and investigative skills in working relationships
• Strong sense of urgency and a desire to roll up sleeves to do the work.

Qualifications (Experience and Education)

• Degree in Life Sciences, Nursing, or related field; Master’s degree preferred.
• 5+ years of experience with patient and product facing roles specifically in the medical device industry.
• 5+ years of experience in clinical operations, specifically in the medical device industry based on deep Good Clinical Practice Knowledge
• 7-9 years of clinical safety experience and adverse event reporting in pharmacovigilance, clinical research or regulatory affairs in a CRO, medical device, or pharmaceutical company required.
• Demonstrated knowledge of technical and clinical aspects of product portfolio.
• Must be excellent with technology, able to present using a laptop and able demonstrate proficiency with Excel, Word, PowerPoint, Outlook, NCBI, Clinicaltrials.gov, FDA platforms
• Experience developing and maintaining relationships with physician customers and field reps
• Experience with development of educational content and delivering systematic training
• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

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