Principal Writer, MW & Submission Planning

Employer
Celgene
Location
San Diego, CA
Posted
Apr 30, 2018
Ref
1801442
Required Education
Bachelors Degree
Position Type
Full time

Other Locations:US- CA- San Diego- Science Park


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.

  • 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

  • May direct the entire document portfolio required for a project (eg, an NDA submission or an early development program)

  • Provide direction to team on content and optimal data presentation/summarization in the document

  • 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

  • Develop the strategy for document preparation and the document review processes, including the management of timelines

  • Facilitate document review meetings and discussions

  • 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

  • Participate in planning for medical writing resources and contribute to the development of project timelines

  • Manage teams and medical writing projects

  • Review work of other writers for accuracy, quality, focus, and adherence to format and stylistic requirements

  • Serve as mentor for medical writers and senior medical writers

Knowledge and Skill Requirements:

  • Minimum of BS/BA degree in science (Masters or PhD preferred) with approximately 5-10 years of regulatory writing and submission experience

  • 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

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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.