Job Order: 5120
Staff Representative: Tim Jadwin
Position: Senior Director, Systems And Operations
Location: Illinois
Company Summary:
Our client, a large pharmaceutical company, is dedicated to serving patients by providing innovative products that improve their lives with better healthcare. With a foundation built on a robust, early-stage pipeline, our client is a world class pharmaceutical company.
Description:
Objective:
The purpose of this position is to successfully lead Global Medical & Scientific Affairs systems and operations function. This position is responsible for the establishment, coordination and support business critical MSA systems and operations to ensure global alignment of processes, content, and compliance (e.g. SOP, etc).
Accountabilities:
- Set and lead strategic direction of GMSA systems and operations group, under the guidance of Head of GMSA.
- Lead, direct and follow through on increasing cross-functionaland cross-regional collaboration among MSA functions of multiple sites, specifically the systems and processes for sharing medical information.
- Establish and direct long-range planning and development programs to ensure optimum use of group resources and capabilities to achieve global growth and profitability.
- Develop and execute an annual program plan and budget consistent with GMSA’ goal.
- Develop strategies and plans to integrate and share medical information globally, including common medical documents (e.g. PIR in U.S., CRD, etc.), ISRs, off-label uses, medical & scientific literatures and publications, and others.
- Oversee development and maintenance of global medical information database, delivery of medical information to internal stakeholders and scientific support at professional meetings and trade exhibits.
- Lead the design and development of global medical information response (e.g. PIR in US), standard response letters (CRD), etc, and their databases.
- Provide access to the GMSA databases to regional/local MSA to increase their efficiencies and ensure consistency across regions. Support training on use and implementation.
- Integrate and support global access of the Intelligencenter resources amongst regions and negotiate global licensing contracts to leverage efficiency.
- Propose and develop appropriate tools and technology (computer system and software, etc.) that could be used to continually enhance the services provided by GMSA.
- Leverage collected information to support SPPD, regional marketing functions, and other divisions/departments and its affiliates, including PRD and PDD.
- PharmD, MD, or PhD in a health science discipline with clinically relevant experience
- 10 plus years medical affairs experience in the pharmaceutical industry
- 5+ years managerial experience
- 5+ years Product commercialization, launch and life cycle management experience
- Experience interacting with Medical and Scientific Affairs organizations in foreign countries.
- Understands US/EU/JP regulations relative to IND, adverse events, consumer communication, medical communications and filing strategies (strong knowledge about one region and a certain degree about other regions)
- Industry Knowledge - understands the pharmaceutical industry and the prescription drug distribution process in a large healthcare organization or prescription drug vendor
- Product Knowledge -understands medical/therapeutic impact of products; understanding of potential product applications
- Operations - understands global operating structure and methods
- Leadership - ability to provide ongoing feedback and coaching to employees and guides leaders within the department and global teams in doing the same
- Leadership - ability to use confidence, decisiveness and a willingness to listen to influence and engage others in the accomplishment of functional and global team goals
- Budget Management - ability to develop an operating budget to monitor and control expenditures; manages variances between budgeted and actual expenditures of time, dollars, and personnel
- Communication - ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner
- Analytical Skills - ability to analyze a wide variety of scientific data including financial figures and market research data to make management decisions
- Business Process Acumen - ability to apply the knowledge of core business capabilities to help the organization meet its goals and desired outcomes
- Strategic Approach - ability to predict broad-based changes in business partner environment and translates them into functional strategies to continually meet business partner needs
- Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables and models for others to use
- Knowledge Management - ability to document resolution to issues and or customer concerns in a manner that ensures reusability of that resolution
- Pharmaceutical Industry Acumen -ability to develop and implement business solutions based on trends, opportunities, needs, and market direction within the pharmaceutical industry
- Requires approximately 20% travel.
- Intercontinental business trips: about four times a year
