Jobs at Aspen Pharma Group

OBJECTIVE OF ROLE

• To provide state-of-the-art medical insight into the GenMed therapeutic area and/or specific molecules to Local and International teams for Aspen and Third Parties.
• This position is a field-based position for the cardio-metabolic therapeutic area within the Medical Affairs organization, to maximize Aspen’s value propositions through first-class medical and scientific projects, services and expertise, with key scientific customers. The MSL will interact with healthcare professionals to communicate and advance the scientific platform as aligned with Aspen’s corporate goals and objectives. The MSL is an integral position in assuring accurate, clear, and valued information regarding our scientific platform is communicated to multiple levels within the medical community. The MSL will communicate complex cutting-edge scientific information and research concepts to healthcare decision makers. The role may also include clinical and pharmacoeconomic value discussions with payers and formulary decision makers. The MSL is also responsible for training key stakeholders (both internal and external) to ensure they are updated on new data. In addition, the MSL will provide insights and feedback based on field interactions and scientific
• support consistent with Aspen’s corporate goals and objectives.

KEY RESPONSIBILITIES

• Establish and maintain an in-depth scientific and clinical understanding of related clinical area
• Identifies, develops and maintains collaborative relationships with current and future KOLs, scientific experts, cooperative study groups and study sites
• Engage in scientific exchange with healthcare professionals to communicate and advance the scientific communication platform, as aligned with Aspen’s corporate goals and objectives
• Communicate complex, cutting edge, scientific information and research concepts to healthcare professionals
• Respond to unsolicited inquiries consistent with the MSL compliance standards
• Provide and/or present field observations and insights to internal stakeholders
• Delivers targeted internal training for selected topics (e.g. study update, congress news, latest scientific developments)
• Supports Head MSL/Medical Manager in developing local territory Medical tactics
• Execute scientific engagement plan according to annual MSL goals and metrics
• Develop and implement local KOL plans in line with scientific engagement plan
• Develops required qualitative and quantitative reports; collates competitor information
• Implements and disseminates high quality medical and scientific educational programs
• Attend and support congress activities as aligned with strategy
• Ensures society engagement: MSL support of international, regional and local congresses
• Identify / recommend sites for Aspen’s partners clinical trials in conjunction with clinical development organizations
• Manage the field activities related to the submission and execution of Investigator Supported
• Studies (ISS) in line with Aspen’s existing policies
• Provide scientific support, consistent with the MSL compliance standards, for commercial, corporate accounts, and other matrix colleagues who may forward HCP inquiries
• Discusses scientific value messages, clinical outcome and patient benefits with KOLs, hospital pharmacists and local payers in close collaboration with KAM/Market Access
• Lead and/or participate on committees or project teams that support MSL strategies and tactics as delegated by Brand Team 80 % travel/infield
• Ensures conduct of work in line with compliance regulations

Requirements
EDUCATIONAL REQUIREMENTS

• Medical or scientific education or experience from similar positions
• Advanced degree (MBChB, PhD) preferred or strong demonstration of equivalent combination of relevant educational and professional training

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• Minimum 2 years of experience in industry, or a related scientific field in academia
• Experience affiliate Medical Department or Clinical Development
• Willingness to travel; possesses valid driver’s license
• Experience with clinical study management and conduct
• Medical / scientific research experience
• Network of customer contacts
• Scientific expertise in the therapeutic area, related products, disease state, and interested in latest discoveries
• Knowledge of value messages, clinical outcomes and patient benefits for the products
• Has solid understanding of country health care system and decision-making, stays on top of changes
• Demonstrates strong project management and presentation skills
• Knowledge of commercialization and business practices
• Good knowledge of clinical research, drug safety, legal and compliance environment
• Willingness to continuously expand medical, scientific, market, and industry knowledge

SOFT SKILLS REQUIREMENTS

• Scientific expertise in the therapeutic area, related products, disease state, and interested in latest discoveries
• Knowledge of value messages, clinical outcomes and patient benefits for the products
• Has solid understanding of country health care system and decision-making, stays on top of changes
• Demonstrates strong project management and presentation skills
• Knowledge of commercialization and business practices
• Good knowledge of clinical research, drug safety, legal and compliance environment
• Willingness to continuously expand medical, scientific, market, and industry knowledge
• Can leverage the collaboration with other functions such as Commercial and Access

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Description
Overview:

• Process and application owner for Automation and Manufacturing systems across site.
• Manage, plan & execute CI projects as well as provide required support as SME.

Responsibilities:

Support and Reliability

• Application owner for all Manufacturing systems and software packages.
• Responsible for Automation Architecture design and site standards for automation.
• Implement corrections, corrective actions, and countermeasures arising from CAPA’s.
• Develop scope for capital projects targeted at both short and longer term needs.
• Act as user representative for capital projects or delivery agent for local projects.
• Understand equipment reliability issues with the objective of improvement.
• Provide technical expertise of equipment and processes in area of responsibility. This includes clear understanding of equipment flow chart/process flow document, critical process parameters, and master formula instructions for the process.
• Monitor/trend control systems as tool for verifying and optimizing equipment performance.
• Lead troubleshooting efforts to resolve more complex process and software problems.
• The Maintenance Tech/Electronics Tech is the first line of support in troubleshooting but will involve the Automation Process Specialist as needed.
• Utilize formal problem solving techniques, including Root Cause Analysis, FMEA to resolve equipment issues related to Automated systems
• Respond to and initiate OEM requests related to complex Technical/software issues.
• Communicate effectively with others, especially process team members, customers, engineering, and production personnel , providing technical insight.
• Provide Application systems oversight to Electronics Tech(s) that support the area.
• Evaluate all activities for impact on qualified state of applications/servers where application changes or software changes are requested.
• Participate in Periodic Reviews for industrial network performance
• Lead or participate in IQ/OQ/PQ and commissioning activities for software upgrades or implementation of new applications in the Virtual Environment.
• Coordinate with asset management personnel to align on improvements and assure alignment of useful lifecycle of hardware and related software to build risk register and submit Capex requests
• Identify and drive improvement opportunities (procedural changes, upgrades, projects, etc.) associated with equipment within the area.
• Goals/objectives should target world-class levels of operation for safety, quality and customer service

Continuous Improvement & Projects

• Work with production supervisors and managers for optimal efficiency to meet the needs of internal and external customers
• Communicate regarding schedule adjustments
• Develop and manage project plans for software upgrades
• Lead automation equipment lifecycle upgrade projects across site
• Provide input to project User Requirements Specifications as per developed standards
• Develop obsolescence plan for installed automation equipment.
• Assist CI team on OEE process improvements
• Ensure change controls are actioned appropriately

Risk management

• Communicate automation and application risks to HOD and production departments.
• Lead risk assessments for IT related security patch updates or network outages related to manufacturing systems.
• Lead risk assessments for automation failures that have resulted in deviations or CAPA’s
• Review CPP and CQA’s for critical manufacturing processes

Operational Input

• Provide technical and operational input for manufacturing investigations
• Provide technical reports and feedback as required for Automation/application related queries.
• Effectiveness reviews of CAPA’s implemented.

Requirements:

Background/ experience

• N6 or equivalent NQF level certificate (e.g. Electronic or Electrical Engineering) in Electronics or similar with 3 yrs experience in an Electronics Technician role OR High School diploma with 5+ yrs experience in an Electronics Technician Role within a pharmaceutical manufacturing facility.
• Siemens Accredited Training
• Proficient in PLC programming, Networking and IT systems (Virtual Environments)
• Siemens Step7, Siemens TIA, Siemens WinCC, Versiondog, Wonderware system Platform, Metasys Building Management, Vshpere Virtual Environments, Pharmagraph
• Electronics experience in a pharmaceutical sterile manufacturing environment
• Computer literacy: proficiency in Excel, Word, Power point and ERP system

Competencies

• Complex pharmaceutical process experience
• Problem solving techniques
• Project management
• Risk Assessment
• Planning and Organising