Medical Director, Medical Affairs- CNS/Psychiatry

4 weeks ago

Florham Park New Jersey, United States AbbVie Full time
Job Description

Provides medical, scientific, strategic and operational leadership and expertise into core medical affairs activities such as: generation of clinical and scientific data) (enhancing therapeutic benefit, safety, and value) health-care professional and provider collaborations and interactions;); medical education, scientific communications and digital engagement, and benefit/risk. Works closely with cross-functional medical partners to support medical affairs activities that advance the appropriate and safe use of our medicines. Serve as a champion for HCP and patient perspectives and ensure commercial teams receive evidence-based medical input into core brand (product) strategies, and marketing (promotional material generation and product launches) and market access activities. 

 

Responsibilities: 

Initiate and lead medical affairs activities, data generation and dissemination supporting the overall medical/scientific strategy. 

Lead or support the design, analysis, interpretation, and reporting of scientific content of study protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. 

Oversee the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities. 

Participate in the design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies. 

May have responsibility for oversight of select clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. May help support study enrollment and overall timelines for key deliverables. 

Ensure / supervise the development of scientifically accurate and clinically relevant marketing materials, medical education programs, advisories, and symposia.  

Assist with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. 

Lead, support and/or coordinate appropriate scientific and medical activities with internal stakeholders (i.e., commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions. 

Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members and clinicians related to disease and therapeutic area information. Keeps abreast of the latest advances in the therapeutic landscape, medical/scientific literature, and innovations in technology and healthcare service delivery to support role as a trusted therapeutic area resource. 

Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities. 

Responsible for understanding and acting in accordance with the highest regulatory requirements and standards related to clinical studies and global drug development and other medical activities. 

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