Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Responsibilities will include, but are not limited to, the following:
- Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
- Prepare or assist with preparation of key documents e.g. Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc.
- Review literature and prepare summary documents for inclusion in IB, protocols, Briefing documents, etc.
- Participate in Development Planning for assigned compounds.
- Protocol preparation (writing, reviewing and cross-functional facilitation as appropriate).
- Assist with review of ongoing summary data including: safety, primary efficacy variables, laboratory data.
- Clinical study report preparation.
- Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects.
Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field),
7-10 years experience in clinical research development or equivalent.
- 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 allaspects of the drug development process
- 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.