Description
Department Name
Clinical Development & Medical Affairs (CDMA)
Job Summary
Primary Role
Provide a brief summary describing the major role, responsibilities and purpose of the job. Summarize key areas of accountability and budget responsibility, if applicable.
Provides comprehensive medical and scientific support for Shire product portfolio within a local operating company (LOC). Primary responsibilities include medical and scientific education for internal and external colleagues, collaborative support for commercial activities and therapeutic expert development.
As appropriate for the LOC, responsibilities also include ensuring adherence to applicable laws, codes and regulations.
Essential Functions
Responsibilities
Describe the essential job duties.
Internal Medical/Scientific Support (50%)
Serve as a resource to the company on therapeutic area knowledge and interacts as needed with CDMA partners such as CDO&B, Regulatory, Compliance, and Commercial Functions
Participate in internal therapeutic advisory groups and project teams
Provide input and participate in cross-functional therapeutic projects such as publication planning, slide-deck development, scientific training initiatives at the LOC level
Provide medical and scientific disease and product training to the sales forces
Provide local medical support to the XXXXX global pharmacovigilance department
Provide scientific support for local reimbursement dossiers
Review and approve LOC promotional materials and activities, including congresses and meetings, ensuring compliance with applicable laws, regulations and codes of practice.
External Medical/Scientific Support (30%)
Develop and deliver quality medical education/scientific presentations in a variety of internal and external settings and to obtain valuable feedback that can be disseminated throughout the organization
Discuss research cooperation with experts to fill knowledge gaps we might identify for XXXXX products
Respond to requests for information from healthcare professionals
Provide speaker training as appropriate for qualified speakers identified by the LOC
Attend and/or manage Advisory Panels and other special projects involving thought leader interaction
Attend selected appropriate national and international professional meetings to represent XXXXXX, respond to medical and scientific questions and enhance the development of therapeutic expert relationship
Technical knowledge (20%)
Maintains a high level of technical expertise through familiarity with disease and therapy area knowledge and expertise, including competitor information, in relation to the XXXXX product and pipeline portfolio.
Develops and maintains updated knowledge of applicable current pharmaceutical regulations, guidelines (eg, GCP), codes of practices and Shire policies related to medical program activities.
Education & Experience Requirements
Include educational requirements or equivalency, required years and type(s) of experience, and necessary licenses or certificates. Specify which are required and which are preferred.
Required:
Medical Doctor degree is preferred, alternatively PhD, PharmD degree with industry experience
Proficient in English language
Desired:
2 years pharmaceutical industry experience, with experience in medical affairs/medical program functions preferred.
Relevant therapeutic area research or substantive patient care experience
An established track record of effective and influential oral presentations within the healthcare profession
Knowledge of local, regional and international regulatory requirements as applied to product development, promotional activities, and pharmacovigilance
Understanding of pharmaceutical regulations, guidelines, codes of practices required
Key Skills and Competencies
Describe critical skills needed to successfully perform job, which should be representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Building Authentic Relationships
Works to Build Authentic Relationships for the Future: Works to build trusting relationships with individuals in anticipation of future working opportunities or business potential. Communicates the philosophy that trust is a two-way process and takes the lead both verbally and through one's own actions.
Global and Cross Boundary Communication
Creates the Conditions for Successful Collaboration: Builds processes that allow for information sharing and an understanding of what each other can offer. Builds good morale, cooperation and cohesiveness within the team. Initiates activities and events designed to improve relationships with others. Promotes and protects the group's reputation in the interest of both the team and Shire.
Serving Customers
Addresses Customers' Underlying Needs: Goes significantly beyond the norm to be available to customers during critical periods. Knows customers' businesses and proactively seeks information about real, underlying needs beyond those expressed initially. Attempts to anticipate customers' needs before they are expressed.
Judgment and Decision-Making
Evaluates Immediate Business Impact: Thinking through how decisions will impact the team. Shire and customers prior to execution. Uses one's knowledge of the issue at hand to conduct a thorough cost-benefit analysis regarding the decision one is about to implement. Once a plan is in place, sticks to the plan and moves on to the next decision in line with the business direction. Is able to change decisions to meet changing priorities.
Accountability and Ownership
Accepts Personal Ownership for End Outcomes: Expresses responsibility for seeing a task to completion or achieving a desired result. Resists temptation to excuse failures by citing variables that are outside one's own control. When faced with challenging circumstances, finds creative ways to ensure the achievement of the desired outcome.
Other Job Components
Complexity and Problem Solving
Describe the decisions made by the incumbents on a regular basis. Include decisions within the incumbent's authority to make as well as those decisions that must be referred to a higher level.
Incumbent is responsible for assessing multiple competing tasks and demands, identifying priorities and managing deliverables
Incumbent is responsible for prioritizing projects and seeking direction from supervisor as appropriate
Appropriate assessment of the situation and ability to communicate realistic expectations to external contacts
Internal and External Contacts
List contacts this job advises, consults and coordinates with on a regular basis. Describe to whom this job is accountable. Indicate each Contact Category (Internal, Vendor, Customer, or Other) and provide examples.
The role will have routine daily interactions with any of xxxxxs internal functions; key functions including Clinical Development and Medical Affairs, Clinical Development Operation and Biometrics and several commercial functions. The role will work closely with the CDMA Medical Director and Medical Science Liaisons if applicable.
External interactions include vendors providing services and project capabilities and professional organizations, therapeutic experts, and academic and medical/scientific professionals.
The position is accountable to the Medical Director, LOC.
Other Requirements
List any other job requirements, including domestic travel, international travel, driver's license, physical abilities required, etc.
Domestic, and potentially international, travel may be required to support Medical Affairs activities. Duties may often call for early or late meetings and attendances at meetings on holidays and weekends.
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