Medical Affairs Clinical Specialist - JJMT Neurovascular

Johnson & Johnson•Irvine, CA

19d

About The Position

Johnson and Johnson Neurovascular is recruiting for a Medical Affairs Clinical Specialist located in Irvine, California, USA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. We are looking for a highly motivated Medical Affairs Clinical Specialist to be part of our Medical Affairs team in Johnson & Johnson MedTech – Neurovascular. In this role, you will serve as the clinical, medical and scientific lead for clinical trials in the J&J MedTech Neurovascular portfolio. This role provides medical oversight, clinical direction and scientific expertise throughout study design, execution and reporting to ensure trial validity. The Medical Affairs Clinical Specialist collaborates closely with cross-functional teams to support successful trial delivery aligned with Johnson & Johnson’s clinical development strategy.

Requirements

Bachelor's degree is required. Advanced degrees such as Masters of Science, PhD are preferred.
Minimum 2 years of experience working in clinical, safety, scientific or life science fields is required
Ability to analyze and interpret scientific data quickly and accurately.
Excellent interpersonal, communication and presentation skills, with the ability to effectively communicate complex scientific concepts to both scientific and non-scientific audience.
Highly self-motivated, independent, and adaptable to changing priorities and environments.
Demonstrated project management skills.
Excellent computer skills, especially with the use of Microsoft Office.
Work authorization in USA.
Travel Requirement: up to 20%.

Nice To Haves

Neurovascular experience is preferred.
Neurovascular knowledge is preferred.
Previous clinical trial experience is preferred.

Responsibilities

Serve as the primary study medical lead for company sponsored clinical studies.
Support the clinical trial team to complete studies 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.
Review and interpret clinical data, ensuring medical accuracy and consistency with the current medical literature.
Contribute to drafting and reviewing 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) and Data Monitoring Committee (DMC) meetings as required.
Develop strong collaborative relationships with the study core team and other internal and external stakeholders to ensure study progress for assigned projects and that issues are identified and communicated to the next management levels.
Provides informed clinical input during study team meetings.
Support the generation of preclinical & clinical evidence strategies to support clinical claims and participate in characterizing the product's capabilities and clinical workflows in collaboration with Marketing, R&D, and other development team members.
Supports the clinical operations teams by providing critical medical and scientific input to ensure product safety and efficacy.
Works with cross-functional partners in R&D, Clinical Research, Regulatory Affairs Biostatistics and Data Management and other departments on product development and pre- and post-approval clinical evidence activities.
Performs other duties assigned as needed.

Benefits

The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year