drjobs Scientific Director, International Medical Affairs - Gastroenterology

Scientific Director, International Medical Affairs - Gastroenterology

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1 Vacancy
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Job Location drjobs

USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

The Scientific Director International Medical Affairs - Gastroenterology provides medical and scientific strategic and operational input into core medical affairs activities including but not limited to: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); internal and external educational initiatives (medical education scientific communications training and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities).

  • Works closely with commercial teams to provide strategic medical input into core brand (product) strategies and to support medical affairs marketing activities (promotional material generation and product launches) and market access.
  • Develops and maintains professional and credible relationships with key opinion leaders.

Responsibilities:

  1. Leads and coordinates appropriate internal facing scientific and medical activities with internal stakeholders (i.e. commercial clinical operations discovery statistics regulatory etc) including but not limited to evidence gap workshops scientific platform and narrative external expert engagement mapping medical education projects and planning ahead of key scientific meetings/congresses aligned to the Medical Functional Plan
  2. Provides scientific/medical education to investigators clinical monitors and Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
  3. Initiates medical affairs activities generation and dissemination of data supporting the overall scientific strategy
  4. Leadership of external Medical Affairs activities such as but not limited to advisory boards congress support medical education programs training and symposia.
  5. Assists in the development of scientifically accurate marketing materials medical education programs advisories and symposia. Assists with the scientific review development approval execution and communication of medical affairs sponsored or supported clinical research activities.
  6. Ensures budgets timelines compliance requirements are factored into medical affairs programs and scientific activities.
  7. Participation in the design analyses interpretation and reporting of scientific content related to protocols Investigator Brochures Clinical Study Reports and regulatory submissions and responses.
  8. Participates 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.
  9. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements

Hybrid in Lake County IL 3x per week. May consider remote candidates  


Qualifications :

  1. Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D) or PhD in relevant field. Completion of residency and/or fellowship is preferred.
  2. Minimum of 5 years of clinical trial or medical affairs experience in the pharmaceutical industry. Experience in pre launch/launch activities for  indications within Gastroenterology preferred.
  3. Knowledge of clinical trial methodology data analysis and interpretation regulatory requirements governing clinical trials and experience in development strategy and the design of protocols. Deep understanding of the clinical research and development process.
  4. Ability to run a clinical study independently with little supervision.
  5. Proven leadership skills in a cross-functional team environment
  6. Ability to interact externally and internally to support business strategy.
  7. Must possess excellent oral and written English communication skills.
  8. Experience working within Gastroenterology highly preferred


Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

  • 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

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Yes


Employment Type :

Full-time

Employment Type

Remote

Company Industry

Key Skills

  • EMR Systems
  • Post Residency Experience
  • Occupational Health Experience
  • Clinical Research
  • Managed Care
  • Primary Care Experience
  • Medical Management
  • Utilization Management
  • Clinical Development
  • Clinical Trials
  • Leadership Experience
  • Medicare

About Company

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