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Clinical Project Scientist
Requisition ID: 8826180412
Janssen Scientific Affairs, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Clinical Project Scientist to be located in Horsham, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Scientific Affairs, LLC is dedicated to providing medical information and consultative support to the Janssen pharmaceutical companies.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
You will be collaborating with the therapeutic area leadership, is a key role between the Janssen Medical Affairs research group and the various operational counterparts in Global Development Organizations (GDO) that works to achieve successful implementation of investigator initiated studies (IIS), company sponsored trials and post marketing commitment registries, done through insourced, outsourced or matrixed organizations. This individual will focus on IISs, Phase II – Phase IV trials and post marketing commitment registries conducted globally, in addition to other Medical Affairs projects to ensure strategic level plans are executed in a timely and compliant fashion for achievement of Medical Affairs’ goals.
In this exciting role, you will:
- Act in concert with medical directors, therapeutic area leaders and Health Outcomes partners, to serve as a liaison between the company and clinical investigators; develop credible relationships with internal opinion leaders, GCO (Global Clinical Operations) staff, and key regulatory officials. Act as the key liaison for our GCO partners and other scientific and business related disciplines (GMA, GMS, QA/QM, Compliance as well as R&D and Supply Chain).
- Partner with Medical Directors in generating research concept sheets for new company sponsored studies and help marshal concept sheets through internal review bodies, as well as external review bodies (e.g., local review committees and co-license partners and Jansen affiliates).
- Assist in development of full protocol documents and case record forms for Medical Affairs programs. Assist preparation of oral and written internal/external presentations (e.g. at Steering Committee and data safety monitoring boards meetings).
- Work with therapeutic area leaders and operational staff, serve as a liaison between company and clinical investigators; develop, in collaboration with senior clinical staff, credible relationships with internal opinion leaders (e.g. CDTLs and GMALs).
- Support Director, Clinical Operations and therapeutic area leaders with franchise clinical initiatives (program quality, tracking against financial targets, metrics/ timelines). Initiatives may include support of advisory boards, investigator meetings, data safety monitoring boards (DSMB), clinical division meetings, business plan & strategic plan process, management of internal and external registries.
- In concert with medical/clinical personnel, the Clinical Project Scientist: will assist with execution of clinical studies, interpretation of results, and preparation of oral and written internal/external presentations, including FDA or Regulatory body submissions; will assist in the development, management, and tracking of trial budgets, and in budget and contract development with third party vendors.
- Responsible for tracking and managing adverse event data collection across trials (IIS and company sponsored); and where appropriate, incorporation into obligatory regulatory documents. Interface with GCO Safety personnel and Global Medical Safety.
- A minimum of a Bachelor’s degree in life sciences, healthcare or related field is required
- A minimum 3 years of clinical trial experience within the pharmaceutical industry is also required
- Therapeutic area experience is highly preferred
- Experience with IIS research is highly preferred
- Experience in supporting or overseeing vendor or grant contracts is preferred.
- Company Sponsor trial experience is required
- Strong business/finance acumen is required
- Ability to operate in a matrix environment with cross functional alliances is required
- This position will be located in Horsham, PA and will require up to 10% domestic travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Janssen Scientific Affairs, LLC (6120)