Provides technical and scientific guidance for specific project or area of treatment or disease
Works with cross functional teams (regulatory, medical affairs, market access, business units, etc.) to evaluate new clinical projects and study strategy
Develops clinical study designs and facilitates the transition of projects to clinical operations team
Develops central trial documents and contributes to clinical development files
Participates in the preparation and review of study-related plans, training materials, and regulatory updates
Determines format, evaluation, and interpretation of clinical data
Presents clinical trial data internally to relevant stakeholders
Leads activities for disclosure of clinical trial data through clinical study reports, abstracts, slide and poster presentations, and manuscripts
Key stakeholder in development of clinical publication and communication strategies
Develops and maintains relationships with physician experts to ensure proper alignment of clinical development strategy
Contributes to risk resolution by escalating and monitoring project risks
Maintains effective communication with cross functional teams and stakeholders
Performs literature reviews for area of treatment or disease
Provides broad medical and scientific support, including training and continuing education, to both internal and field-based teams
Participates in medical education and appropriate scientific exchange to enhance product and disease state knowledge
Maintains knowledge as to developments and trends in applicable treatment landscape including current treatment strategies, and new therapeutic
Requirements
Master's degree in Life Sciences, Health Sciences, or Engineering and 2 years of direct, relevant biotech/pharma industry clinical research experience
PhD in Life Sciences, Health Sciences, or Engineering
Strong background in data mining, literature searches, and scientific, medical and/or regulatory writing
Experience in the conduct and management of clinical studies; Experience in writing study protocols and other technical documents; Working knowledge of regulatory authorities and other regulatory requirements
Proficient knowledge of Microsoft Office software, and other general office equipment. Proficiency or comfort level working with material of a highly technical or scientific nature.
Benefits
Must maintain company quality and safety standards
This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.
Maintain regular and punctual attendance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical study designdata miningliterature searchesscientific writingmedical writingregulatory writingclinical trial managementstudy protocol writingrisk resolutionclinical data evaluation
Master's degree in Life SciencesMaster's degree in Health SciencesMaster's degree in EngineeringPhD in Life SciencesPhD in Health SciencesPhD in Engineering