Medical Writing Operations Leader - New Jersey, United States - Daiichi Sankyo, Inc.

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 16,000 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.

The Oncology Early Development Center (OEDC)

Program Lead, who directly reports to the Head of the OEDC, supports the OEDC and its leadership triad: 1) Head of OEDC and KEE Chair, 2) Scientific Committee Chair, and 3) Infrastructure Committee Chair.

This position is critical in transforming Daiichi Sankyo (DS) Oncology Early Development Center (OEDC) so as to be regarded as one of the world's most innovative, trustworthy, and experienced oncology early development focused centers.

This role will help the OEDC Leadership Team (OLT) to accomplish its vision to promote innovative, science-driven portfolios with an equally robust and agile infrastructure.

The Program Lead plays a central role in supporting OEDC to drive strategy and to manage and facilitate key global DS oncology early development initiatives.

The Program Lead will have direct accountability for administrative deliverables, will interact regularly with senior leadership and will play a role to integrate OEDC with internal scientific and functional line areas as well as externally with OEDC stakeholders, both internal and external.

This role will assist the OLT with assessing portfolios, preparing documents and communications, and conducting a final review of materials prior to OLT submission.

This position acts as a "change agent" within DS to ensure compliance and alignment with DS highest standards.

This position interfaces with senior Scientific and Infrastructure Committee members on key scientific and infrastructure issues to facilitate OEDC's role in defining oncology early development strategy and execution for DS.

This position provides direct oversight of the internal OEDC staff necessary for meeting the daily operations as well as the strategic objectives of the center.

1) Head of OEDC and KEE Chair, 2) Scientific Committee Chair, and 3) Infrastructure Committee Chair, the Program Lead will ensure a smooth operating environment. WIll manage the day-to-day operation of OEDC.

Attends and participates in all Committee meetings, specifically the Scientific, Infrastructure, and KEE committees and all other meetings as necessary.

Delivers routine, concise updates on project statuses and next steps and supports thorough preparation of the Scientific, Infrastructure and KEE committees for upcoming discussions, commitments, meetings and governance forums; Will assist the OEDC Network Lead in maintaining and managing the DS FIH Site Network.

Will work with the OEDC Administrative Coordinator in the fulfillment of their duties. This includes review and editing of OEDC communication, including the website, FAQ site, and regular OEDC newsletter.

Interacts regularly with senior leadership and assists in integrating OEDC with internal scientific and functional line areas and with internal and external OEDC stakeholders.

Reviews and edits all OEDC documents and communications, including meeting notes from the Scientific Infrastructure, and KEE committees.

Assists the OLT with assessing portfolios, preparing documents and communications, and conducting a final review of materials prior to dissemination.

Assists OEDC leadership with timely submission and compliance of all required DS documentation for quality control/assurance, legal, finance, operational and educational requirements.

Provides oversight of all OEDC activities and direct oversight of internal OEDC staff necessary for meeting the daily operations as well as the strategic objectives of the center.

Is directly accountable for administrative deliverables.
This includes liaising with senior executives in global RD, GCO, and other functional areas.

Promotes Oncology Early Development knowledge through oversight of the OEDC fellowship program through partnerships with academic institutions, content development for the OEDC website, and participation in the OEDC lecture series.

Uses data-driven decisions to improve responses to OEDC stakeholders (GPTs, functional lines, KEEs, DS leadership), identifies issues with service responsiveness, performs root cause analysis, identifies improvements, and measures success.

- Coordinates with OEDC leadership and stakeholders globally to ensure effective communication, effective decision making and consensus building where required.

Identifies risks and develops and implements risk mitigation plans.

Interfaces with senior Scientific and Infrastructure Committee members on key scientific and infrastructure issues to facilitate the OEDC's role in defining oncology early development strategy and execution for DS.

KPIs, KQIs, and other speed and quality metrics) through the use of dashboards.

Collaborates with the OEDC Network Lead to provide updates from the DS FIH Site Network and the KEEs to the OEDC monthly newsletter.

The OEDC Program Lead leads an agile team in a rapid growth environment and conducts all other duties as assigned.

Plans, assigns and directs work for successful OEDC operations; sets direction and manages competing priorities as appropriate.
Uses quality improvement techniques to increase the quality of all OEDC work.
Develops and implements plans in collaboration with global and local teams to raise the profile of OEDC.

Bachelor's Degree Evidence of high performance at all levels of education required

• PhD Life Sciences preferred
• 10 or More Years Experience in pharmaceutical scientific research and operations methods and processes in industry setting required
• Experience with phase 1 oncology trials in either a pharmaceutical or academic organization preferred
• Professional writing and communication preferred
• Familiarity to a Japanbased organization preferred Travel

Ability to travel up to 30%. In-house Office position that may require occasional travel (domestic and global).

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.