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Description
About Celgene
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 60 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 and hematology. If youd like to join a company where you can make a difference, please consider the Celgene family.
Prerequisites
Completed BS/BA degree in Biomedical Science (completed MA/MS degree or higher preferred) required.
Previous leadership or supervisory experience required.
Must have 5 or more years of professional working experience in the pharmaceutical industry or in CRO, including 3 or more years of professional medical writing (specifically for regulatory submissions) experience.
Must have extensive experience writing all types of clinical & regulatory documents and with registration dossiers for worldwide use.
Must have strong ability to analyze industry trends for study reports and international dossier preparation, including electronic document submissions (eCTD), and synthesize standardized solutions.
Expertise in multiple therapeutic areas required.
Summary
1. Working with other relevant line functions, prepare phase 1 - IV clinical and regulatory documents and submissions, including:
Investigator Brochures, clinical study reports, integrated summaries of efficacy and safety, registration dossiers, package inserts, and responses to health authorities.
2. Participate in study and clinical team meetings and assist the teams in resolving issues related to document preparation.
3. Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
4. Prepare internal guidelines for document preparation.
5. Prepare templates for clinical documents that are consistent with FDA and ICH guidelines and with electronic submission guidelines.
6. Develop the strategy for document preparation, including time frames that meet or exceed company standards and the document review processes.
7. Facilitate document review meetings and discussions.
8. Participate in the development of outsourcing plans for medical writing.
9. Manage outsourced medical writing projects.
10. Review work of other writers (in-house or contract) for accuracy, quality, focus, and adherence to format and stylistic requirements.
11. Train and guide other writers (in-house and/or contract) in company policies and procedures related to document preparation.
12. Assist with preparation of presentations for major external meetings.
13. Assist with transferring and presenting clinical / regulatory data to Marketing for journal submissions.
Skills/Knowledge Required:
Completed BS/BA degree in Biomedical Science (completed MA/MS degree or higher preferred) required.
Must have 5 or more years of professional working experience in the pharmaceutical industry or in CRO, including 3 or more years of professional medical writing (specifically for regulatory submissions) experience.
Extensive experience writing all types of clinical & regulatory documents and with registration dossiers for worldwide use.
Knowledgeable in preclinical development including discovery, toxicology etc.
Knowledge of FDA and ICH guidelines.
Ability to analyze industry trends for study reports and international dossier preparation, including electronic document submissions (eCTD), and synthesize standardized solutions.
Ability to work with complex projects and within cross-functional teams.
Experience working with CROs.
Expertise in multiple therapeutic areas.
Excellent grammatical and communication skills, both written and oral.
Expertise in MS WORD, including the ability to solve technical problems with WORD templates.
Previous leadership or supervisory experience required.
Equal Employment Opportunity
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 employees 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.
Details:
Job Id:
19245219
Posted / Updated:
10/9/2010 3:39:37 AM
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