Manager Medical Writing

Company: Daiichi Sankyo, Inc.
Location: Basking Ridge
Posted on: January 24, 2023

Job Description:

Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryUnder the supervision of the Associate Director or Director, this position will be responsible for the hands-on preparation of protocols, Investigator Brochures (IBs), and Clinical Study Reports (CSRs). As a content expert, this position must have a working knowledge of and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics). Support for compilation of appendices and narrative support.ResponsibilitiesServes as primary author on a variety of clinical documents (protocols, CSRs, investigator brochures), with guidance as needed from MW management and functional area experts; Understands clinical data and uses text, tables, and figures as appropriate to accurately and effectively convey key messagesOrganizes and leads cross-functional meetings to determine timelines and processes for document developmentSupports Associate Director/Director in management of outsourced activities, including development of CSR safety narrativesParticipates in appropriate development teams and internal strategy and operations meetingsChecks electronically published CSRs for completeness (including Section 16 appendices) and adherence to company's electronic publishing standards before archivingParticipates in development of medical writing processes and working standards; Uses knowledge of document development best practices to continuously improve medical writing SOPs, templates, and house style guide10Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)Bachelor's Degree 5+ years of experience as a medical writer with a Bachelor's degree in a relevant scientific field requiredMaster's Degree 2+ years of experience as a medical writer with a Graduate Degree in a relevant scientific field preferred Experience Qualifications2 or more years experience with a Graduate Degree, with Regulatory/Medical writing experience and submission document experience required5 or more years experience with Bachelor's degree, with Regulatory/Medical writing experience and submission document experience preferredTravelAbility to travel up to 5% Ability to travel up to 5%In-house/remote office position that may require domestic travel.Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Keywords: Daiichi Sankyo, Inc., Newark , Manager Medical Writing, Executive , Basking Ridge, New Jersey