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Senior Scientist, Clinical Research Job
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.
Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field), 5-10 years experience in clinical research development or equivalent
Responsibilities will include, but are not limited to, the following:
1. Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
2. Prepare or assist with preparation of key documents e.g. Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc.
3. Review literature and prepare summary documents for inclusion in IB, protocols, Briefing documents, etc.
4. Participate in Development Planning for assigned compounds.
5. Protocol preparation (writing, reviewing and cross-functional facilitation as appropriate).
6. Assist with review of ongoing summary data including: safety, primary efficacy variables, laboratory data.
7. Clinical study report preparation.
8. Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects.
- Minimum 1-2 yrs. experience in medical or technical writing
- Extensive medical/scientific and clinical research knowledge
- Knowledge of Medical Terminology
- Knowledge of protocol design, implementation and proficient at data interpretation
- Experience in protocol development, study report preparation, Investigator Brochure preparation, IND safety updates
- Experience in all aspects of the drug development process (device & tissue experience an added benefit)
- Knowledge of GCP and ICH Guidelines
- Experience in presenting at Investigator Meetings
- Detail-oriented, well-organized
- Limited travel required
- Ability to assimilate technical information quickly
- Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project a plus
- Demonstrated ability to work as part of a team
- High level of interpersonal and communication skills (written and verbal)
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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