Assoc Dir Case Management in Bernards, NJ at DSI

Date Posted: 11/1/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Bernards, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/1/2018
  • Job ID:
    9407BR

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:
This position oversees case processing activities, projects, and procedures. This level interacts within CSPV and with CROs, vendors, and partners; and participates on interdepartmental study teams. This level handles escalated CSPV case processing, handles project oversight issues, and participates in hiring, compensation, and personnel management decisions. This level oversees NDA PADERS and IND safety section preparation and coordinates training, as needed, and reports to Level VI (Director of Case Management Operations).

Responsibilities:
  • Case Processing: Oversees daily case processing staff assignments, activities, and projects and interacts with vendors, CROs, and partners on a daily and as-needed basis. Oversight of the management of staff workload, projects and initiatives, and management of escalated case processing issues/trouble-shooting. Oversees CAPA implementation. Oversees management of staff administration issues including work schedules, rewards and discipline. Conducts mid-year and annual performance reviews of direct reports, contributes to compensation and hiring decisions.
  • Vendor Case Processing Oversight: Acts as subject matter expert in case processing and provides management oversight and decision making for case processing project and trouble shooting. Identifies and arranges for CRO/vendor training as needed. Reviews overall processes and identifies areas of concern, arranges for remediation of same. Monitors CRO/vendor reports (daily, weekly, monthly as required by project) to ensure quality completion of deliverables. Lead for PV CRO/vendor projects. Works with Strategic Partner Management Lead to manage relationship with CROs and Vendors.
  • Case Processing Policies and Procedures: Reviews, approves, and provides input on SOPS, SOIs, and process guides. Participates in inspection preparation activities and internal and external audits and audit CAPA preparation.
  • PV Representative on Study Teams: PV contact for study teams as needed and oversees staff assignments on study teams. May attend multidisciplinary study team meetings and provide management oversight of initiatives and trouble shooting. Participates in study start up activities related to case processing as needed.
  • Aggregate Reports: Participates in the preparation of quarterly Case Processing Compliance and Volume Report. Works with the Aggregate Reports Coordinator to ensure the Case Processing team supports preparation of aggregate reports. Oversees NDA PADERS and IND safety section preparation.

Qualifications

Education and Experience
  • Bachelor’s degree in nursing, pharmacy, life sciences, health care or related field;
  • Minimum of three (3) years of management experience in PV;
  • Minimum of ten (10) years of Drug Safety/Pharmacovigilance experience, including both investigational and marketed products;
  • Extensive knowledge of AE and drug coding conventions (MedDRA, WHO-DD).
  • Extensive knowledge of FDA regulations, clinical and safety databases,
  • Familiarity with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP)
Competencies
  • Ensures high quality work is completed throughout the function and that internal and external expectations and timelines are met.
  • Develops functional strategic plans, provides guidance on priorities within the function and leads implementation.
  • Expertly identifies issues independently, thoroughly understands cause of issues, recognizes functional impact, develops and implements solutions.
  • Expert scientific knowledge is used to provide leadership and to serve as subject matter expert throughout the function.
  • Routinely interfaces, collaborates, and negotiates with project and functional leaders to drive results and resolve complex issues.
  • Assists in driving timely management decisions, appropriately shifts functional timelines, resources and priorities to address regional needs.
  • Applies clinical trial knowledge to influence strategy and promote efficiency and compliance for assigned projects within the team and externally.

Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.