Jobs in All Categories (18) Healthcare (3) Human Resources & Legal (2) Operations & General Management (2) Sales & Business Development (1) Science & Education (10)
Lead and/or participates in the company preparations for regulatory inspections, including working with Subject matter Experts in Inspection Readiness Activities.
Collaborate with the company internal CMC teams and associated CMO/CRO organizations to enable the completion of planned analytical activities in accordance to agreed scope, timing and budget.
Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting; ability to complete assignments on-time and on-budget.
Broad working knowledge of GCP/ICH/FDA requirements, clinical trial design and strategy, commercial and publication strategy, and medical information process.
Strong working knowledge of the clinical drug development process Track record in the conduct/participation in clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strength decision-making.
Lead the assessment of our health and welfare benefits strategy and direct the design, implementation, communication and cost control of health and welfare benefit programs for employees globally.
The Head US Medical Affairs will have a leading role in managing effective relationships with Key US Opinion Leaders.
Lead and develop a team of medical director and medical scientists assisting the development and implementation of the global medical strategy for niraparib.
Manage the resolution of compliance issues identified at clinical and non-clinical vendors and clinical sites and provide assessment of the impact of any deficiencies.
May be involved in the creation of an improved reagent inventory planning and management system for both small and large molecules, including standardization of material shipping processes.
Develop an in-depth understanding of the needs of oncology patients and demonstrated a focus on activities to meet those needs.
Represent at medical meetings, advisory boards and outreach meetings as needed/appropriate.
Develop a strong understanding of the strategic framework and responsible for translating to Core Team goals.
Strong credibility within the US medical community which includes the ability to reach out to key thought leaders in academia.