Principal Medical Writer II

Job Description

Req #: 1901506
Location: Summit, New Jersey, United States
Job Category: Medical
Work Location: 86 Morris Avenue 07901
Organization: Medical Writing
Employee Status: Full-time
Job Type: Regular
Other Locations: United States-California-San Diego

Job Description
Responsibilities will include, but are not limited to, the following:
1. May act as medical writing lead on submission team or early development program. Author and give directions for preparing clinical and regulatory documents, including Investigator’s Brochures, Clinical Study Reports (CTD Module 5), Integrated Summaries of Efficacy and Safety (CTD Module 5 for FDA),
Clinical Summaries of Efficacy (CTD Section 2.7.3) and Safety (CTD Section 2.7.4), Clinical Overviews (CTD Section 2.5), Pediatric Investigation Plans, Proposed Pediatric Study Requests, Requests of Product Specific Waivers and Confirmation of the Applicability of Class Waivers, applications for Orphan Drug
Designations, and responses to health authorities
2. May direct the entire document portfolio required for a project (eg, an NDA submission or an early
development program)
3. Provide direction to team on content and optimal data presentation/summarization in the document
4. In collaboration with medical writing and other functions, prepare internal guidelines for document
preparation and templates for clinical documents that are consistent with EMA, FDA and ICH guidelines,
and with electronic submission guidelines
5. Develop the strategy for document preparation and the document review processes, including the
management of timelines
6. Facilitate document review meetings and discussions
7. May contribute to Clinical Trial Data Sharing activities, including act as the lead for team review and
redaction of private patient and/or confidential commercial information from documents, manage data
sharing projects and vendors
8. Participate in planning for medical writing resources and contribute to the development of project timelines
9. Manage teams and medical writing projects
10. Review work of other writers for accuracy, quality, focus, and adherence to format and stylistic
requirements
11. Serve as mentor for medical writers and senior medical writers
Prerequisites:
Minimum of BS/BA degree in science (Masters or PhD preferred) with
approximately 5-10 years of regulatory writing and submission experience
Skills/Knowledge Required:
• Experience writing clinical and regulatory documents
• Experience with registration dossiers for worldwide use preferred
• Understanding of drug development processes
• Knowledgeable in preclinical development including discovery, toxicology etc
• Knowledge of EMA, FDA and ICH guidelines
• Ability to work with complex projects and within cross-functional teams
• Experience with effectively managing vendors and contract writers to meet timelines/project objectives
preferred
• 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/mentoring experience preferred

About Us
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.