Other Locations:US- NJ- Summit East
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.
Summary/Scope: Support the overall Clinical Study Subject Narrative Process within the Hematology/Oncology Clinical Research and Development Function in order to deliver the Clinical Study Narratives to the study teams with efficiency and accuracy.
Responsibilities will include, but are not limited to, the following:
Author and QC assigned Clinical Study Subject Narratives as needed. Ownership of identifying studies for narrative writing with the study teams. Coordination and development of the required narrative lists with programming/CRS for all studies. Assist in the development of narrative plans with the Associate Director, Clinical Narrative Lead. Coordination and development of the AESI lists for every study for incorporation into the narrative plan. Prepare and complete all narrative workflows to CQA, incorporation of comments, and CRP approval in eSub. Maintain the clinical narrative folders for all studies. Assist with the narrative automation process as needed. Assist the Associate Director, Clinical Narrative Lead with narrative metrics and tracking.
- BA/BS or equivalent degree preferably in life sciences or allied health field
- At least 3-5 years writing and clinical research experience (oncology preferred). Data management experience a plus.
- Understanding and good use of all study documents: protocol, SAP, CRF, SMQs, MS Word, Data Listings, and CSRs.
- Experience in worldwide registration studies and large studies.
- Experience in driving, managing and collaborating in a team/matrix work environment
- Expertise in MS WORD, Sharepoint, and Excel, including the ability to solve technical problems with WORD templates.
- Excellent grammatical and communication skills, both written and oral.
- Ability to work with complex projects and within cross-functional teams.
- Ability to anticipate and resolve problems.
- Proficiency in data interpretation.
- Experience working with automated data solutions in clinical documents.
- Ability to work in a complex, fast changing environment.
- Sound organizational skills.
- Knowledge of FDA/ICH guidelines and industry standard practices regarding clinical research and development.
Key (PDI) Competencies:
- Planning: Develops short and long-range plans that are appropriately comprehensive, realistic and effective in meeting goals; integrates planning efforts across work units.
- Develops Systems & Processes: Identifies and implements effective processes and procedures for accomplishing work.
- Effective Speaking: Speaks clearly and expresses self well in groups and in one-on-one conversations.
- Listens to Others: Actively attends to and conveys understanding of the comments and questions of others; listens well in a group.
- Displays Organizational Savvy: Develops effective give and take relationships with others; understands the agenda and perspectives of others; recognizes and effectively balances the interest and needs of one’s own group with those of the broader organization
- Fosters Teamwork: Builds effective teams committed to organizational goals; fosters collaboration among teams; uses teams to address relevant issues.
- Commitment to Quality: Emphasizes the need to deliver quality products and/or services; defines standards for quality and evaluates products, processes and/or services against those standards; manages quality
- Recognizes Global Implications: Seeks to understand issues, trends and perspectives of various cultures and countries; addresses cultural and geographic differences in strategies and approaches.
- Demonstrates Adaptability: Handles day-today work challenges confidently; is willing and able to adjust to multiple demands, shifting priorities, ambiguity and rapid change; show resilience in the face of constraints, frustrations or adversity; demonstrates flexibility.
- Analysis of Issues: Gathers relevant information systematically; considers a broad range of issues or factors; grasps complexities and perceives relationships among problems or issues; seeks input from others; uses accurate logic in analyses.
- Innovation: Generates new ideas; goes beyond the status quo; recognizes the need for new or modified approaches; brings perspectives and approaches together combining them in creative ways.
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.