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Manager Medical Writing (Operations)

Employer
Daiichi Sankyo
Location
Remote by Design Home Office
Start date
Sep 28, 2022

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Discipline
Clinical, Medical Writing, Manufacturing & Production
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

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.

Summary

Provides support to the Medical Writing organization through document processing in the company's EDMS and eTMF. Leads the compilation of document-specific appendices (eg, CSR, briefing book) in association with the Documents Lead/Lead Medical Writer and CRO, if applicable. Is highly proficient in Submissions Vault and regularly trains/advises others. As requested by the Documents Lead/Lead Medical Writer, assists in the planning and execution of clinical and regulatory documents; is knowledgeable in the requirements of GCPs, global SOPs and templates, FDA regulations/EU CTR Directive, and ICH guidelines. Using available tools and technology and systems/processes knowledge, accomplishes tasks with minimal supervision.

Responsibilities

  • Manage, oversee the assembly of, and ensure the quality of ancillary/appendix documents in binders; ensuring documents are processed per global SOPs, filed appropriately and ensuring there is no duplication within the EDMS, and as needed, in the eTMF. Work with external third parties as necessary in the execution of the Medical Writing strategy and vision for CSR and other document appendices
  • Support BLA/NDA/IND submissions by tracking and performing quality checks (QC) on various components (as needed), filing documents into the appropriate location in the company’s EDMS, and following up with appropriate subject matter experts.
  • Process Driver for Safety Narratives (CSR and 90 DSU), IBs, and other documents as requested including development of the narrative plan and maintainance of the narratives tracker; vendor and reviewer oversight/liaison; coordination with Lead MW of kick-off meeting and CRMs; liason with QA; initiation of esubmission readiness and approval workflow for the final deliverables.
  • For various document types at the request of MWs, create the EDMS binders and subfolders, initiate esubmission readiness/approval workflows, ensure all the components are complete/approved/ready to be published, etc. Edit and format documents as requested by MWs.
  • Maintain current literature content for submissions in the company’s EDMS and make new references eSubmission Ready by using Acrobat plug-ins such as ISI tool
  • Mark documents (IB, CSR, narratives) for redaction in compliance with EU CTR
  • Crosslink Submission Vault documents into eTMF, upload KOM presentations and conduct Sponsor Functional QC in eTMF as requested by MW for MW documents
  • Interact with multi-disciplinary team members and work closely with MW stake holders to ensure that tasks are completed within the agreed timelines

Qualifications: 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 in medical writing/regulatory operations/document excellence with a Bachelor’s degree in a relevant scientific field preferred
  • Master's Degree 2+ years of experience as in medical writing/regulatory operations/document excellence with a Graduate Degree in a relevant scientific field preferred Experience Qualifications
  • 4 or More Years medical writing/regulatory operations/document excellence preferred

Travel

Ability to travel up to 10% Remote office position may require domestic travel to headquarters offices.

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.

Company

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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.

For more information, please visit: www.daiichisankyo.com.

Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com.

STOCK EXCHANGE: Tokyo Stock Exchange

STOCK SYMBOL: 4568

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Find Us
Website
Phone
(908) 992-6400
Location
211 Mt. Airy Road
Basking Ridge
New Jersey
07920
United States
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