Assoc Dir GMA Oncology - Publications

Daiichi Sankyo•Basking Ridge, NJ

About The Position

Associate Director, Global Medical Affairs Oncology Publications works with GMA Oncology Publications Lead, to develop publication plans, drive the execution of publication projects, and support other GMA Oncology activities as needed for their assigned product.

Requirements

Bachelor's Degree preferably in Health Sciences required
An advanced degree preferably in Health Sciences strongly preferred such as a: PharmD in Health Sciences preferred or PhD in Health Sciences preferred
Must have at least 7 or more years overall related experience or commensurate education/experience required
Experience with publication planning required
7 or more years with publication/communication agency for MS degree in health sciences.
4 or more years of pharmaceutical industry, clinical, and/or academic experience for candidate with either a PharmD, or PhD
Must have publications expertise from within the pharmaceutical industry
A proven track record of working successfully with cross-functional teams to achieve goals.
Must have the ability to travel both domestic and global up to 20%

Nice To Haves

Experience with clinical trials and international work experience preferred

Responsibilities

Collaborate with alliance partners, Global and Regional Medical Affairs and various cross functional teams to develop and execute publication plans of assigned GMA Oncology product
Facilitate Publication discussions
Liaise with internal external authors, academic research organizations, and study investigators
Manage vendor budget and activities
Oversee the quality and timeline of vendor work
Collaborate with study clinical or medical lead and biostats to ensure availability of necessary data
Coordinate author review/approval internal review approval
Abstract/manuscript submission with vendor support
Facilitate response to journal reviewer comments/requests
Publication tracking and announcement, in coordination with Medical Information Education (ME)
Leads the planning, execution and delivery of publication projects to ensure high quality and timely delivery of scientific publications
Manage publication activities in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures and author approvals
Ensure documentation of compliance with authorship and publication guidelines as stipulated by the International Committee of Medical Journal Editors (ICMJE) and Good Publication Practice for Communicating Company-Sponsored Medical Research (GPP)
Work with and oversee publication vendors to ensure deliverables are of high quality, delivered in a timely manner, and in budget. (Applicable for Oncology Medical Affairs)
Liaise with internal and external stakeholders, including authors, researchers, investigators, GMA Therapy Area leads, RD clinical leads, biostatistics and Joint Publications Team members on publication activities
Lead study publication committee discussions, including monthly, quarterly and yearly publication update meetings as needed.
Manage timelines of publication output
Facilitate Publication discussions
Liaise with internal external authors, academic research organizations, and study investigators
Manage vendor budget and activities
Oversee the quality and timeline of vendor work
Collaborate with study clinical or medical lead and biostats to ensure availability of necessary data
Coordinate author review/approval internal review approval
Abstract/manuscript submission with vendor support
Facilitate response to journal reviewer comments/requests
Publication tracking and announcement, in coordination with Medical Information Education (ME)
Support global medical communication plan development by collaborating with GMA team
Support other global data dissemination activities as needed
Support GMA Oncology Publications Lead by assisting with key meetings, acts as delegate
Align with the GMA Oncology Publications Lead and respective team members to ensure robust publication plans for the Therapeutic Area and respective products.
Lead and facilitate Joint Publication Team discussions as needed.
Coordinate author review/approval and internal review approval of manuscripts, abstracts, poster presentations, oral presentations, medical slide deck and other ME materials related to the brand(s).
Manage vendor budget and activities and oversee the quality and timeline of vendor work
Manage Publication tracking and announcement, in coordination with Global Oncology Medical Affairs Team (GMAT) Lead and Medical Information Education or Global Specialty Medical Affairs (GSMA) Team.
Contribute to development of publication plan budget.
Collaborate with GMAT Lead on tracking and management of budget.
Work with and oversee publication vendors to ensure deliverables are of high quality, delivered in a timely manner, and in budget.