Job ID: 14575
Location: Basking Ridge, NJ -110
Full/Part Time: Full-Time
Department: Hematology/Oncology - 3606
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), 7-10 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. Assist the Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects
3. Prepare or assist with preparation of key documents e.g. Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc.
4. Review literature and prepare summary documents for inclusion in IB, protocols, Briefing documents, etc.
5. Protocol preparation (writing, reviewing and cross-functional facilitation as appropriate).
6. Clinical study report preparation.
7. Participate and present at investigator meetings
8. Participate in Development Planning for assigned compounds.
9. Oversees and challenges the adequacy of planning for study implementation
10. Assist in establishing project budgets
11. Assist with review of ongoing clinical data including: safety, primary efficacy variables, laboratory data.
12. Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects.
13. Participate in functional development/initiatives
- Minimum 2 yrs. experience in medical or technical writing
- Extensive medical/scientific and clinical research knowledge
- Knowledge of protocol design, implementation and proficient at data interpretation
- Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics
- Experience in protocol development, study report preparation, Investigator Brochure preparation, IND safety updates
- Experience in all aspects of the drug development process
- Knowledge of GCP and ICH Guidelines
- Clinical project management skills
- Detail-oriented, well-organized
- Ability to assimilate technical information quickly
- Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project a plus
- Experience working with electronic data capture systems
- Demonstrated ability to work as part of a team
- High level of interpersonal and communication skills (written and verbal)
Limited travel required
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.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.