Medical Affairs Specialist

Medical Affairs Specialist 

Location: Galway, Ireland - Hybrid working

Duration: 23 months 

Hours: 39 per week

Cerenovus, part of the J&J family of companies is currently recruiting for a Medical Affairs Specialist to be located in Galway, Ireland.

The Medical Affairs Specialist is a key executional partner who will provide scientific and clinical expertise to internal stakeholders throughout the neurovascular product lifecycle to ensure product safety, effectiveness, and evidentiary needs are met for successful commercialization and adoption.  The role collaborates closely with cross-functional teams (for example the medical and clinical operations team, R&D, clinical research, quality and regulatory affairs) to support the writing of the technical dossiers for regulatory bodies by reviewing from a medical perspective, supporting risk management activities including providing benefit-risk analyses, ensuring clinical and marketing claims are appropriate and well supported, and responding to medical information requests.

roles and responsibilities

Under limited supervision and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this will involve:

• Serves as the primary medical representative for product development projects (new products as well as lifecycle products). The main responsibilities include being the medical core team member on some product development project teams.

• Provides expertise in technical dossier review for regulatory bodies (such as FDA or MDR) from a medical perspective for products in development and in lifecycle management.

• Write the risk benefit analysis (RBA) in collaboration with Quality, Regulatory, and R&D.

• Review from a medical workflow perspective the documents related regulatory compliance such as the State of Art Review (SOAR), Clinical Evaluation Report (CER), Post-Market Clinical Follow-up (PMCF), or questions from Notified Bodies.

• Support the medical and clinical operations teams by providing critical medical and scientific input to ensure product safety and efficacy, and provide adjudication for off-label and mis-use.

• Provide clinical risk perspective for copy review of marketing material for commercially available products

• Contribute clinical/medical expertise with risk documentation analysis (dFMEA, pFMEA, aFMEA)

• Contribute and support the risk assessment process for marketed products in concert with the Quality Engineering team.

• Works with cross-functional partners, e.g., R&D, Clinical Research, Regulatory Affairs, Quality & Compliance, Pre-Clinical, Health Economics & Market Access and Professional Medical Education on product development and pre- and post-approval clinical evidence activities.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Performs other duties assigned as needed.

how to succeed

Experience and Education:

• A minimum of a bachelor’s degree is required, Master of Science or PhD are preferred.

• A minimum of 5 years of clinical, engineering or life science experience is required.

• Neurovascular experience is preferred.

• Neurovascular knowledge is preferred.

• Previous industry experience working with Medical/Clinical/R&D teams in a highly regulated, commercial medical device business is preferred.

• Proven track record of marketed product support (including development and compilation of regulatory documents such as CERs; labelling updates and copy approval) is required.

• Demonstrated knowledge and experience in quality compliance, regulatory compliance, and healthcare compliance, and Medical Device Regulation (MDR) is preferred.

Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations:

• Ability to understand, interpret and communicate complex scientific and medical information to diverse audiences.

• Strong interpersonal and scientific communication skills (written and verbal).

• Self-starter who can work effectively within cross functional teams

• Project management skills

• Ability to work effectively in a matrixed environment

benefits

This role offers a very competitive hourly rate. This contract will run for 23 months and has a strong chance of extension. 

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Cerenovus

Cerenovus is part of Johnson & Johnson MedTech and an emerging leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. At Cerenovus we offer a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke. Contribute to the next healthcare breakthrough with your next project at Cerenovus. 

https://www.jnjmedtech.com/en-US/companies/cerenovus

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.