Medical Affairs Trials Specialist

Medical Affairs Trials 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 Trials Specialist to be located in Galway, Ireland.

The Medical Affairs Trials Specialist is a key executional partner who will provide scientific and  medical expertise towards execution of company sponsored clinical trials.  This role will collaborate closely with the Clinical Affairs Department to serve as Study Medical Lead or assist assigned Study Medical Lead for several clinical trials, ensuring compliance with timelines and study milestones, while fostering strong, productive relationships with colleagues across the organisation. This position will require an analytical individual with a keen eye for detail and passion for clinical research. 

roles and responsibilities

• Serving as the study medical lead for company sponsored clinical studies, supporting the clinical trial team to execute on the study in a safe, effective, and timely manner.

• Contribute towards development and approval of clinical trial protocols, informed consents, investigator brochures, committee charters, and other study materials

• Conduct routine review of safety events, adverse events (AEs), medical coding, source documents, and subject narratives 

• Contribute to drafting and review of study reports for assigned studies to include annual reports (APR), study close out reports (CSR) as well as other regulatory submissions

• Attend Clinical Events Committee (CEC) meetings as required

• Develop strong collaborative relationships with the study core team and others internal and external stakeholders  to ensure study progress for assigned projects and that issues are identified and communicated to next management levels

• Provide informed clinical input during study team meetings

• Support the generation of the preclinical & clinical evidence strategies to support clinical claims and participating in characterizing the product's capabilities and clinical workflows in collaboration with Marketing, R&D, and other development team members.

• Work 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

• Partner with Clinical Research teams in the development and execution of product and/or procedural evidence generation and dissemination strategies

• Support early product introduction to the market supporting launches as well as internal & external training

• Perform other duties assigned as needed

how to succeed

Experience and Education:

• A minimum of a bachelor’s degree is required, MD, DO, MBBS, PhD, or other relevant clinical / scientific background is 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 supporting clinical 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”.