Medical Affairs Project Manager

  • location: San Rafael, CA
  • type: Contract
  • salary: $32.68 - $38.45 per hour
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job description

Medical Affairs Project Manager

job summary:

location: San Rafael, California
job type: Contract
salary: $32.68 - 38.45 per hour
work hours: 9 to 5
education: Masters
Job Responsibilities

  • Provide technical expertise in Epidemiology to develop and maintain a Real World Evidence strategy to support products from clinical development through licensing, market access, and lifecycle management. Specific activities include:
  • Participates in new drug development programs as a Subject Matter Expert (SME) in the areas of Real World Evidence & Epidemiology
  • Evaluation and monitoring of literature in therapy area as well as advancements in Epidemiology methods and policy/acceptance of Real World Evidence by regulators/payors
  • Critically appraise existing epidemiology evidence and create new evidence through delivery of specific research protocols and analysis of healthcare databases and prospective burden of illness studies
  • Improve disease understanding relevant to the target patient population: incidence, prevalence, risk factors, natural history disease course, burden of illness, treatment patterns, co-morbidities, co-medications, outcomes measures, phenotypes, biomarkers and unmet need, and their variations across demographics and geographies
  • Support post marketing activities: Conduct of post marketing post authorization safety studies and post marketing effectiveness studies/registries, epidemiology studies for safety signal detection, evaluation of risk mitigation strategies
  • Develop strong partnerships with internal stakeholders in a multi-disciplinary framework (Market Access, Medical Affairs, Clinical Development and Commercial functions) to support Real World Evidence needs
  • Develop and negotiate research plans with external collaborators in academia or contract research organizations and work effectively to oversee external groups through the research process
  • Effectively communicate study findings to an internal and external audience base
  • Extend a track record of external publications in peer review journals and international congresses
  • Develop SOPs, guidelines, and templates to support conduct of Real World Evidence and Epidemiology studies
Education & Qualifications

  • A combination of academic training and practical experience in epidemiology is required. This may consist of:

    • Doctoral degree (PhD, ScD, or DrPH) or Master's of Public Health in Epidemiology (MPH) (Preferred)
    • Clinical degree (ie. Medicine, pharmacy, nursing) and a master degree in Epidemiology with at least 5 years of experience leading epidemiologic research
    • Master's degree in a relevant discipline (ie. Health services research, health outcomes research, public health, statistics, or pharmaceutical sciences) with at least 5 years of experience leading epidemiologic research
  • Demonstrated experience conducting pharmaco-epidemiologic research within or in support of the pharmaceutical industry
  • Self motivated with the ability to work independently to develop credibility with colleagues, as well as interact effectively in multi-disciplinary matrix teams
  • Experience in collaborating with research partners
  • Ability to work well in a business-driven environment, balance priorities and handle multiple tasks through careful planning, stakeholder management, project administration, and organizational skills
  • Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings
  • Record of high quality, peer reviewed epidemiology or outcomes research publications preferred.
  • Experience in the epidemiology of rare diseases or genetic epidemiology a benefit
skills: SOP, Epidemiology, Pharmacoepidemiology
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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