Director, Medical Writing and Submission Planning

Employer
Celgene
Location
San Diego, CA
Posted
Mar 19, 2018
Ref
1800612
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.

This position manages the development of all clinical and regulatory documents, publications, and conference materials. This position builds strong relationships with Regulatory Affairs, Biostatistics, Clinical Operations, Clinical Development, Project Management, and other functional areas.

Position is located at 3033 Science Park Road, San Diego, CA.

Major Responsibilities:

  • Manage and develop direct reports and resourcing plans across multiple products

  • Provide guidance on medical writing aspects of regulatory submissions and contribute to submission strategy

  • Develop the strategy for timelines, document preparation, SOPs, and guidance documents

  • Lead the project management efforts in the preparation of clinical and regulatory documents and submissions,

  • 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

  • Develop subject matter experts for key medical writing processes

  • Review document content and be accountable for the work of medical writers

  • May lead kickoff meetings, data interpretation, document review meetings and discussions

  • Participate in cross-functional team meetings and assist the teams in resolving issues related to document

  • preparation

  • May review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of

  • presentation

  • 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 vendor

  • Prepare presentations for major external meetings, as needed

  • Assist Senior Director with forecasting staff needs based on planned programs and submissions and internal

capacities

Knowledge, Skills and Abilities Required:

  • Advanced scientific degree (MA/MS, PhD, PharmD, MD preferred) with approximately 15  years of regulatory writing & submission experience and experience managing writers as direct reports

  • Previous experience with managing direct reports/contractors and in developing resourcing plans

  • Experience with regulatory requirements for various types of submissions (eg, pediatric plans and orphan drug

  • designations)

  • Extensive experience writing clinical & regulatory documents and leading preparation of registration dossiers

  • for worldwide use

  • Ability to influence decision makers, promote change, and lead process improvement initiatives

  • Experience with effectively managing vendors and contract writers to meet timelines/project objectives

  • Expertise in multiple therapeutic areas

  • Excellent communication skills, both written and oral

  • Experience with MS Office and electronic document management and publishing systems

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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.