Senior Associate, Legal Operations - Basking Ridge, United States - Daiichi Sankyo

Description

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.

SummaryThis position is responsible for the overall quality of materials subject to Product Material Review Process (PMRP) - including but not limited to: Brand sales materials, Training Department materials, Managed Markets sales tools, speaker slide decks, Website materials, advertising and New Product Planning materials.

This individual will be an integral member of the brand teams as well as the Product Material Review Team (PMRT) with the Legal, and Medical Affairs departments, ensuring consistency of materials across brands and departments, adherence to corporate guidelines and the final QC sign-off.

This individual will be able to provide cross-functional coverage as needed for PMRP and assist with the scheduling and review of PMRP for Global submissions.

This individual will also be responsible for cross functional assistance for PGC, Learning Management System (LMS) and Regulatory, as needed.

Responsibilities

• Editorial Review of Materials

Review and consult with initiators on promotional material (Brand, Managed Markets, NPP, Training, etc) prior to Product Material Veeva Platform (PMVP) submission to ensure metadata is accurate and submission data is complete for review

Review and edit all promotional material prior to PMRP to ensure adherence to brand guidelines as well as consistency of messaging thereby reducing overall review time and increasing efficiency for review teams

Review materials for errors in grammar, punctuation and spelling; check materials for readability, style and agreement with corporate policy

Respond to inquiries from brands, agencies and PMRP reviewers regarding materials and timelines

• PMRT Member

Review all materials prior to PMVP submission - consult with other PMRP members on materials if needed

Attend all PMRP meetings and concept review meetings

Enter comments into PMVP prior to review of materials

Record agreed upon Product Material Review Team (PMRT) comments for incorporation into the piece by agency/initiator

Conduct training and provide guidance to internal/external customers who interact with PMRT in accordance with the AOP; maintain training documents

• Quality Control of all PMRP Material

Access review material through the PMVP

Confirm all changes have been made and comments addressed throughout various rounds of PMRP

Communicate changes to project initiator/vendor

Provide quality control signoff in PMVP

Provide final PMRP approved PDF to Production for printing

Responsible for uploading final PDF to the PMVP

Generate final approval notifications for distribution

• Extended Brand Team Member

Attend bi-weekly brand team meetings to gain knowledge and understanding of initiatives and messaging

Collaborate with brand teams (all initiators), Product Material Review Team (PMRT) and Production to ensure awareness of incoming materials and timing requirements

Attend workflow management meetings with Production, Distribution & Brands to plan management of incoming materials, POA timeframes and priority projects

• Provide cross-functional support to Legal Operations as needed

Partner with Regulatory Analyst on the submission of all PMRP approved promotional material to FDA as needed

Generate ad hoc reporting requests

Partner with PGC Coordinator on submission and review of PGC requests

Manage the internal tracking and reporting needs for Legal and Corporate Affairs. Revise any training modules as instructed by assigned attorney in Legal Affairs. Assist with the Legal and Corporate Affairs department's use of LMS.

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 required

Experience Qualifications

• 4 or More Years experience in marketing/marketing operations and/or editorial function within the pharmaceutical industry or healthcare advertising industry required

* experience/knowledge of pharmaceutical advertising agency preferred

• Strong working knowledge of Microsoft Office suite of tools and Adobe Acrobat, knowledge of APA preferred

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.

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