Celgene (Document) Specialist I, Clinical Pharmacology in Summit, New Jersey
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.
The Document Specialist I interfaces with the Trial Managers, Pharmacologists, and Pharmacokineticists to perform the QC, formatting, publishing and eSub maintenance of all TD-CP documents.
As part of the Clinical Pharmacology Operations team the incumbent is expected to require moderate supervision. He/She will work together, cultivate open communication and utilize knowledge and skills to partner with clinical stakeholders. This person will provide premium quality operation in all aspects of translational development and clinical pharmacology projects.
Responsibilities will include, but are not limited to, the following:
Provides QC, formatting and publishing support to Translational Development- Clinical Pharmacology, including the Trial Managers, Pharmacologists, and Pharmacokineticists.
Responsible for the QC of all documents written in TD-CP which include protocols, protocol amendments, investigator brochures, clinical study reports, bioanalytical reports and submission documents such as INDs and NDAs for submission to health authorities for quality, correct grammar, spelling, accuracy, and consistency.
Conducts QA/QC reviews of bookmarks and hyperlinks.
Reviews document content for accuracy, completeness and consistency against source documents and source data.
Provides formatting of text and tables for all documents written in TD-CP which include protocols, protocol amendments, investigator brochures, clinical study reports, bioanalytical reports and submission documents to ensure adherence to Celgene style guide.
Communicates changes in the documents described above to authors, including CRO personnel in an effective manner when applicable.
Provides instruction and guidance on templates, formatting and publishing to CROs in accordance to the Celgene style guide.
Interacts with various departments for Document Quality (eg. Regulatory Operations and Clinical Quality Assurance).
Liaises with the Regulatory Operations department to maintain TD-CP electronic document repository, assists authors with initiating workflow's, takes part in the review and approval process of protocols and clinical study reports to meet all eSubmission requirements per Celgene policy.
Works with Clinical Quality Assurance department to initiate and maintain SOP and WP training to department to ensure compliance.
Assists in the development and tracking of new departmental forms, templates, standard operating procedures (SOPs), working procedures (WPs) and guidances.
Supports TD-CP personnel as needed for report management and provides electronic submission training and troubleshooting as needed.
Assists with the compilation of the monthly report for Clinical Pharmacology.
Bachelors Degree / Life Sciences or related field and 4+ years related experience OR Masters Degree / Life Sciences or related field and 3+ years related experience
Basic knowledge of document management
Basic knowledge of clinical development process
Basic knowledge of GCP/ICH guidelines
Basic knowledge of computer applications including document management systems such
Documentum or eSubmission preferred
Able to follow SOPs/WPs
Basic knowledge of SOPs/WPs and templates, and contributes to writing of these documents
Basic knowledge of document formatting/editing/publishing techniques/tools such as ISI Toolbox and all of its features (eg. creating bookmarks and hyperlinks, using the auditor)
Able to multi-task and prioritize with moderate guidance
Excellent written and oral communication skills required.
Must be able to work with moderate supervision and coaching on projects
Candidate should demonstrate creative thinking as it relates to identifying/recognizing issues and recommending solutions to problems.
Ability to escalate higher level issues/ problems to appropriate individuals is desirable.
Must possess strong interpersonal and communication skills, be a team player and be willing to work in a fast-paced environment, where changing project priorities and work assignments require flexibility.
Strong PC experience, Microsoft Office Suite experience required including Microsoft Word; Excel; Outlook; PowerPoint and strong computer acumen.
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.
(Document) Specialist I, Clinical Pharmacology
Location: Summit, NJ, US
Job ID: 17001682