Johnson & Johnson Careers

Manager, Medical Affairs

Irvine, California
Medical Affairs


Job Description

Requisition ID: 1737180910

 

Every six seconds someone dies from a stroke. Stroke can be caused either by a clot obstructing the flow of blood to the brain (ischemic stroke) or by a blood vessel rupturing and preventing blood flow to the brain (hemorrhagic stroke). CERENOVUS is committed to changing the trajectory of stroke by providing physicians with innovative technologies to push the boundaries of what’s possible in neurovascular intervention. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.

 

The Manager, Medical Affairs is a member of the Medical Operation team.  S/he provides medical affairs management of the marketed product. This role will provide expertise in support of the Franchise Medical Strategy in concert with Operating Entity Franchise Medical Leaders.  S/he provides Strategic Medical support for operating companies with no dedicated medical affairs personnel (and as requested for those companies with franchise medical teams).

 

The Manager, Medical Affairs will:

 

•    Provide Lifecycle Management for marketed products including labelling updates, medical support and accountability for technical files and documents and medical support to Quality groups

•    Collaborate closely with the franchise Medical Directors in support of business responsibilities

•    Research, prepare and document responses to Medical Information Requests from Healthcare

providers.

•    Review and approve medical content in Copy Approval process; consults with Franchise

Medical Director when needed

•    Provide consultation to Shared Services in support of literature review, analysis and conclusions for Clinical Evaluation Reports (CER)

•    Provide review of CERs and assists in preparation of periodic safety reports for assigned products

•    Assist in reviewing of risk evaluation (PRE or PRA) documents

     Provide medical oversight of publication strategy for selected marketed products in close collaboration with the Franchise Medical Affairs team

•    Prepare and/or manages preparation of presentations and manuscripts around clinical data as well as medical and scientific information, this includes hands on management of publications and maintenance of timelines

•    Contribute to value dossiers for marketed products

•    Assesse work volumes, effectively prioritizes business needs to meet the demand, and escalates work load constraints accordingly to Sr. Manager of LCM

•    Act as a team member supporting and collaborating with the other LCM managers within their therapeutic space

  • Act as medical monitor for the post medical trials
 


Qualifications
Qualifications
 
 

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

•    Relevant degree is preferred (PhD, RN, BSc, etc.)

•    Some direct patient contact is preferred

•    Clinical experience with medical devices and knowledge of clinical trial design, 

      evidence generation, adverse event reporting, surgical practices/principles is

      preferred

•    Demonstrated knowledge and experience in quality compliance, regulatory

      compliance, and healthcare compliance is preferred

•    Operating room experience is preferred

     Lifesciences experience preferred

 
 


Primary Location
United States-California-Irvine
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Medical Affairs
Requisition ID
1737180910