Clinical Affairs Associate

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 person in this role is responsible for supporting clinical data generation and analysis activities to demonstrate the benefits safety and effectiveness of Aerogen Medical devices

What are the key responsibilities
Support Aerogens PMCF programme including literature review IIS and HCP /patient level surveys etc.
Contribute to the creation/maintenance of key regulatory documents under supervision e.g. CERs PMCFP/ERs clinical assessments and HHE.
Act as required as the Clinical Affairs representative on R&D projects as appropriate.
Support Aerogen clinical operations its global evidence program & third-party research activities.
Manage day-to-day Clinical Affairs support of existing studies payments contracting in an efficient manner ensuring records are maintained consistent with GDPs.
Cross-functional and within department collaboration in support of Medical Affairs and Aerogens strategic objectives.
Work closely and under the supervision of senior Clinical Affairs staff.

What education and experience are required
Bachelors degree in a relevant field life sciences or in medically orientateddiscipline.
Relevant other qualifications (e.g. clinical trial experience ISO 14155 certification) or advanced qualification (e.g. MSc) preferred.
Previous experience in a related role in the Medical Device/Pharmaceutical industry a plus.
Medical/Technical writing experience in the Medical Device industry/ Pharma or academia strongly preferred.
Ability to critically appraise clinical/scientific data and literature the application of biostatistics and apply appropriate statistical methodology.

What key skills will make you great at the role
Scientific expertise - strong foundation in medical and scientific knowledge relevant to Aerogens therapeutic area(s).
Medical/Technical writing excellent ability to assess evidence and cogently present same in a variety of formats for a range of audiences.
Compliance/ Regulatory knowledge familiarity with the relevant regulatory guidances (EU/USA) for clinical evaluations and investigations adverse event review and reporting as well as PMCF.
Project management 0 ability to manage competing demands deadlines and balance a diverse workload.
Analytical skills ability to critically analyze clinical data and scientific literature identify trends.
Communication skills ability to communicate complex scientific information clearly to diverse audiences (orally/ written).
Interpersonal skills personable with strong relationship-building skills for interacting with team members cross-functional teams as well as KOLs/HCPs.

What is it like to work in 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. Theres 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 emailprotected. Please include your name and preferred method of contact.