Manager, Medical Information & Education in Bernards, NJ at DSI

Date Posted: 4/25/2018

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise

The vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science Franchise, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary

The Manager, Medical Information and Education will have responsibility for developing and reviewing high quality medical information documents, as well as conducting medical review and approval of promotional and training materials/programs as part of the Promotional Material Review Team (PMRT). The manager may have a primary focus in one of these areas and a secondary focus in the other. The Manager leverages his/her functional and technical expertise to assist in improving organizational effectiveness of the Medical Information and Education function.

Responsibilities

Conduct comprehensive medical review and clearance of materials/programs as a memberof PMRT. Proactively provide medical counsel and medical/scientific direction on strategies for promotional and sales training materials/programs for assigned therapeutic area(s):
  • ensure comprehensive, high quality, medical review and appropriate sign-off/approval of materials/programs in a timely fashion
  • attend PMRT meetings and ensure appropriate coverage for review of PMRT materials and meetings when absent
  • collaborate with other PMRT reviewers from Legal Affairs prior to PMRT meetings to discuss submitted or up-coming materials/programs, as necessary/needed.
  • collaborate with MR&S and/or HEOR as needed to discuss content and scientific rigor of materials/programs and to assure alignment in Medical Affairs, as needed
  • collaborate with Marketing and Sales Training colleagues outside of PMRT meetings as needed (e.g., provide medical guidance, request more background information etc…)
  • provide proactive medical input/guidance to Marketing and Sales Operations on appropriate strategies and messages
  • participate in early planning discussions and strategy review with the Legal Affairs PMRT reviewer
  • consult with supervisor as needed
Develop high quality, scientifically sound Medical Response Documents (MRDs) to fulfill unsolicited requests for information.
  • manage MRDs through the complete drafting, review and approval process as per established AOPs, incorporating (and discussing as needed) input/recommendations from other reviewers (e.g., Peer Reviewers, Legal Affairs reviewer, Supervisor) and discussing with other functions as needed
  • conduct detailed peer review of MRDs and provide appropriate and effective feedback/recommendations.
Serve as integral member of Medical Affairs (MA) and the Medical Product Team to:
  • ensure MI&E is aligned with the overall Medical Affairs strategies, plans and objectives;
  • assure knowledge and information transfer between MI&E and other functions across Medical Affairs;
  • drive the consistency in medical information
  • provide medical support/expertise across functions as needed
  • plan and/or staff Medical booths at select congresses
  • lead or participate in projects/initiatives within MI&E or across functions, as assigned.
  • conduct inquiry analyses, develop reports and analytics
  • provide customer and scientific insights
  • assist in developing/reviewing/updating policies and procedures, sharing best practices across MI&E, training new colleagues
  • assist with post-doctoral fellowship program as needed
Review and provide feedback on various forms of communication of medical/scientific content, including but not limited to slides, abstracts, manuscripts, Standby Statements, Press Releases and FAQs for assigned therapeutic area(s) as needed.

Assist in the management of the Contact Center:
  • ensure quality and efficiency of inquiry and document management, including timely handling of escalated inquiries
  • participate in the training of Contact Center personnel as needed
Assist or lead the development of other medical information documents (e.g., AMCP dossiers, custom dossiers, executive summaries, product testimonials, CMS-approved Compendia submissions etc.)

Interact with DSI Information Systems department for the development and/or updating of systems-based solutions (e.g., electronic inquiry and document management systems)

Qualifications

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience

PharmD strongly preferred; a minimum of 1 year of Oncology experience required; experience in industry in medical review and/or medical information is strongly preferred; proven track record of working successfully with cross-functional teams to achieve results

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.