- 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.
- Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred.
- Minimum of 2 years of medical affairs and/or clinical trial or clinical practice experience in the pharmaceutical industry or academia or equivalent. 3 years of experience is preferred.
- Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Ability to run a clinical study independently with little supervision.
- Proven leadership skills in a cross-functional global team environment.
- Ability to interact externally and internally to support global business strategy.
- Must possess excellent oral and written English communication skills and mastery of basic Microsoft Office software
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
- This job is eligible to participate in our long-term incentive programs
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Medical Director, Medical Affairs- CNS/Psychiatry - Florham Park, United States - AbbVie
Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.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:
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
Note:
No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable.
The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.
It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
