About Aerogen:
Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery.
Recognised through multiple MedTech awards and ten-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients' lives every day, having already reached 20 million patients in over 80 countries.
Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work.
We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care.
Our business is growing rapidly across the globe and as we grow, our core culture of "We Care" universally connects us.
We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers.
Join us as we continue to #discoverbetter.
What is the role?
The Senior Medical Affairs Advisor is a central Medical Affairs SME who helps shape, and leads the review of, promotional materials (PMs).
They are a key stakeholder guiding the generation of compliant, educational materials and Medical Affairs resources.
They identify and respond to the needs of field teams generating resources and providing scientific support and coach/supervise junior staff.
They manage medical information and are a key SME on Aerogen clinical data.
As needed, they may contribute to clinical evaluations to ensure compliant and accurate communication of device benefits and use.
What are the key responsibilities?
Help shape & produce promotional and scientific materials in collaboration with key stakeholders.
Lead & direct the medical review, approval of promotional and scientific materials ensuring accuracy with applicable global regulations, company policies, and codes of practice.
Provide guidance, direction and training on the generation of novel materials, in compliance with global regulations while ensuring cross-functional ethical PMA pathway awareness.
Monitor and proactively communicate relevant scientific and clinical developments to ensure up-to-date knowledge of the company's products and therapeutic areas.
Identify stakeholder needs and lead the generation of resources, evidence summaries and content for internal/external teams including educational content for webinars and HCPs.
Support field teams by acting as a clinical/medical SME, supporting and responding to medical inquiries, and providing clinical insights.
Provide accurate, balanced, and evidence-based medical information to internal and external stakeholders.
Lead the generation and production of Medical Affairs content & resources including publications, education decks, conference manuscripts, webinar slide decks etc.
Collaborate cross-functionally with Marketing, QARA and others to align medical and business objectives within ethical and compliance frameworks.
Participate in internal review committees and serve as the medical representative for designated product areas.
As needed, contribute to the development, review, and maintenance of clinical evaluation reports and related clinical documentation.
Supervisory support and coaching of junior staff and less experienced Medical Affairs Professionals.
Perform other related duties as assigned.
What education and experience are required?
Bachelor's degree in a life science, biomedical engineering, pharmacy, nursing, or related healthcare discipline required.
Advanced degree (Master's, PhD, or MD) in suitable discipline.
In depth proven clinical experience or in Medical Affairs, Clinical Affairs, or a related function within the medical device or pharmaceutical industry.
Strong background in scientific communication, medical writing, and stakeholder engagement and management.
Experienced clinical data reviewer, with working knowledge of biostatistical methods and the critical appraisal of data.
Demonstrable knowledge of relevant medical device regulations and guidelines (e.g., EU MDR, FDA regulations, industry codes of practice), particularly those related to promotional material, Medical-Legal-Regulatory review & Medical Affairs activities.
What key skills will make you great at the role?
Clear understanding of medical terminology, medical device regulations, standards, and industry codes of practice.
Ability to critically review scientific and promotional materials for accuracy, compliance, and clarity.
Excellent medical writing, scientific communication, and presentation skills(previous content generation and/or publication experience a plus).
Proficiency in interpreting and summarizing clinical and scientific data.
Effective collaboration and cross-functional teamwork skills, with the ability to influence and guide decision-making.
Strong problem-solving skills and attention to detail in complex regulatory and medical review processes.
Ability to manage multiple priorities and deadlines independently.
Very strong interpersonal skills with the ability to build relationships with internal teams, external stakeholders and manage conflict effectively.
Commitment to ethical standards and integrity in medical and promotional activities.
Adaptability to evolving regulations, industry trends, and clinical developments.
What is it like to work at Aerogen?
Our purpose is to transform patient lives and our ethos is to #discoverbetter.
This also translates to how we look after our people.
We want talented, passionate and engaged people to join Aerogen and build your career with us.
We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits.
There's something for everyone Here is an idea of what we offer:
Excellent medical care.
Bonus & Pension.
'Aerogen Connect' – our employee led programme which supports our global teams to unite and have fun.
We pledge 1% of profits and time to charities and organisations.
Aerogen is committed to promoting diversity, inclusion and equality in the workplace.
If you have any difficulty using our application process, please contact us by emailing (email protected).
Please include your name and preferred method of contact.