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location: Lexington, Massachusetts
job type: Contract
salary: $130.00 - 144.07 per hour
work hours: 9 to 5
- Provides expert Medical opinion / leadership to the Compassionate Use program.
- Experience writing safety narratives for complex clinical trial subjects.
Review data generated in phase III trials, oversight of CRO medical monitoring and safety coding for sponsored clinical research programs.
- Collaborates with Global Clinical Development Lead, Clinical Scientists, Global Program Lead, Clinical Operations to ensure that all development and product support activities for the therapeutic area(s) are coordinated and consistent;
- Provides scientific advice within R&D for product launches.
- Remains up-to-date with current information on pharmaceutical regulations, guidelines, and therapeutic area knowledge and ensures consistent best practice across all activities. Demonstrates expertise in data review and interpretation of phase III trials to deliver meaningful efficacy and safety conclusions.
- Demonstrates the ability to interpret conclusions in context of
product profiles and medical practice.
- M.D. degree; 3 years minimum clinical development experience
- Demonstrated experience in conducting Phase III clinical trials and ability to collaborate in a matrixed environment.
- Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities preferred.
- Therapeutic expertise (Infectious Disease or Transplant) preferred but not required.
- Demonstrated in-depth understanding of drug development
and working knowledge of regulations relating to drug development.
- Demonstrated ability to communicate and plan effectively with other departments and to respond to inquiries or from CRO and/or investigators.
- Strong judgment and decision-making skills with the willingness to roll up sleeves to assist the team to achieve its goals.
skills: IND, NDA, Phase iii, Maa, GCP (Good Clinical Practice), Submissions, ICH Regulations
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.