Merit Medical Oncology

• Ensures that company procedures (GP, GPS, QSP, etc.) and regulatory standards (FDA, CFR, MDR, ISO, etc.) are followed with respect to assigned areas of responsibility. • Consult with Merit staff regarding the use of products in a clinical setting by clinicians. Provides clinical input for new product design and development. • Works with Sales Representatives and customers to clarify, obtain, and/or better understand the clinical information in relation to reported product complaints. • Answers incoming customer calls to collect clinical information. • Provides clinical training to employees and customers on the complaint system requirements. • Establish relationships and builds confidence among lab staff, physicians, Sales Representatives, and other Merit customers. • Ensures clinical details involving customer complaints are documented. • Attends meetings to help determine which events/incidents require notification to regulatory authorities. • Creates and submits reportable adverse events to regulatory agencies. • May supervise the work of technicians or others who assist in related assignments. • Responsible for complaint Nonconformances (NC’s) and Corrective Preventive Actions (CAPA) and investigates, resolves issues and determines course of action. • Initiates and/or implements action to prevent occurrence or use of nonconforming components, manufacturing materials or finished devices. • Identifies and records any product, process and quality system problems. • Provide clinical input on and approve investigation methods and experiments. • Provide clinical input from a complaint perspective on CRA, HSA and FMEA development. • Write documents to address complaints, investigations, or reports requiring clinical input. • Makes presentations at and/or attends local, regional, and national meetings requiring clinical expertise, knowledge, and experience. • Performs other duties and tasks as required.

• Meeting regularly with clients to present and demonstrate Merit products and explain their benefits • Identifying potential customers and introducing them to the products offered by Merit • Maintaining contacts with clients to monitor their satisfaction with products • Identifying opportunities to improve customer satisfaction with products • Preparing customized drawings for clients needing custom kits or manifolds • Preparing and submitting pricing contracts to clients for products • Following up with clients to identify opportunities to increase sales volume and profitability • Resolving problems with clients regarding manufacturing or delivery problems • Coordinating with other Merit marketing and sales staff • Making decisions regarding product pricing to optimize sales volume and profitability • Preparing a monthly report summarizing sales results • Participating in various sales training and planning meetings • Maintaining a high level of knowledge about Merit and competitor products • Setting and achieving personal performance goals • Participating as a member of the Merit sales team • Traveling by car, airplane, etc. to perform sales duties • Performing a variety of other sales related duties as required

• Presents and sells Merit products to new and existing accounts and follows up with these customers to confirm that products delivered meet their needs. • Makes in-service presentations to clinicians, explaining new products and their use. • Maintains close relationships with clients to ensure that their needs are understood and met. • Coordinates with Merit marketing and sales staff to ensure that products are delivered on time, to stay informed about new products, and to provide customer feedback about product innovation. • Establishes and maintains close relationships with new clients and existing accounts by: Meeting regularly with clients and accounts to present and demonstrate Merit products and to explain their benefits. • Identifying potential customers and introducing them to the products offered by Merit. • Maintaining contacts with clients to monitor their satisfaction with products. • Identifying opportunities to improve customer satisfaction with products. • Preparing customized drawings for clients needing custom kits or manifolds. • Preparing and submitting pricing contracts to clients for products. • Following up with clients to identify opportunities to increase sales volume and profitability. • Resolving problems with clients regarding manufacturing or delivery problems, if they occur. • Coordinates with other Merit marketing and sales staff to ensure that the right products are shipped to customers on a timely basis and in the amount required, to stay informed about new products provided by Merit, and to provide feedback from customers about product needs and possible innovations. • Makes decisions within approved authorization limits regarding product pricing to optimize sales volume and profitability. • Prepares a monthly report summarizing monthly sales results achieved, contacts made, needs for change in products and suggestions for improvement in Merit's procedures. • Participates in a variety of sales training and planning meetings to learn about new products and marketing promotions, and to share information about sales goals. • Maintains a high level of knowledge about Merit and competitor products and their advantages and disadvantages. • Sets and achieves personal performance goals for sales volume, new contacts made, new client sales and other related sales results achieved. • Participates as a member of the Merit sales team to improve Merit's ability to increase market share by identifying ways to increase product quality and customer satisfaction. • Travels by car, airplane, bus, etc. to perform sales duties with clients. • Performs other sales related duties, as required.

• Independently researches, prepares, writes, edits and reviews clinical evidence documents, e.g. CERs and SSCPs. • Conducts proofreading, editing, document formatting, review comment integration and document completion/approval activities. • Supports regulatory approval process through clinical evidence document formulation and responding to regulatory agency questions. • Manages and maintains the procedures, systems and processes required to meet regulatory requirements for clinical evidence documents and ensures they stay up-to-date based on guidance, regulation and feedback from regulators. • Collaborates with cross-functional teams to ensure high quality and successful project delivery. • Develops and maintains in-depth therapeutic and product operation knowledge; applies this knowledge to the development of well written clinical evidence documents. • Provides input to post-market surveillance and risk management activities. • Creates and manages schedule of deliverables. • Conducts training for medical writers, regulatory affairs and other functions, as needed. • May supervise or mentor other medical writers, as assigned. • Performs other duties and tasks, as required.

• Presents and sells specific Merit product groups to new accounts and follows up with these customers to confirm that products delivered meet their needs. • Maintains close relationships with clients to ensure that their needs are understood and met. • Coordinates with Merit marketing and sales staff to ensure that products are delivered on time, to stay informed about new products, and to provide customer feedback about product innovation. • Actively involved with peer education, training, and onboarding of new team members.

• Achieves sales target, increases market share and profitability. • Sets and follows up an action plan aligned with the strategy to achieve goals. • Works closely with teammates to ensure good communication and to combine efforts. • Being present with customers and accounts daily to present and demonstrate Merit products and to explain their benefits. • Identifying potential customers and introducing them to the products offered by Merit. • Maintaining contacts with customers to monitor their satisfaction, address concerns and provide solutions. • Preparing and submitting pricing contracts to customers for products. • Makes decisions within approved authorization limits regarding product pricing to optimize sales volume and profitability. • Implements sales and marketing strategies in the territory. • Enters and follows up sales opportunities and customer information in the CRM. • Coordinates with other departments to stay informed about new products provided by Merit, and to provide feedback from customers about product needs and possible innovations. • Prepares and submit reports to RSM when needed. • Prepares and presents a resume of the activity on a regular basis. • Participates in a variety of sales training and planning meetings to learn about new products and marketing promotions. • Maintains a high level of knowledge about Merit and competitor products and their advantages and disadvantages. • Maintains a high level of knowledge about the clinical environment and clinical studies. • Participates in industry or promotional events (e.g. trade shows, workshops). • Participates in various sales meetings. • Manages consignments on a regular basis. • Travels by car, train, airplane, etc. to perform sales duties with customers. • Performs a variety of other sales related duties, as required.

• Present and sell Merit products to new and existing accounts • Follow up with customers to ensure product satisfaction • Prepare customized drawings for clients needing custom kits or manifolds • Submit pricing contracts to clients for products • Identify opportunities to increase sales volume and profitability • Resolve problems with clients regarding manufacturing or delivery issues • Participate in sales training and planning meetings • Maintain a high level of knowledge about Merit and competitor products • Set and achieve personal performance goals for sales volume

• Answers incoming customer calls promptly to place orders for product sales. • Resolves problems and concerns that customers may have with all facets of product ordering, sales and service. • Tracks product shipments upon the customer's request or Sales Representatives' request. • Enters standing orders, fax orders, blanket orders, and mail orders as needed. • Assists Sales Representatives with customer account problems and sends samples of Merit's products to customers and Sales Representatives upon their request. • Corresponds with Shipping, Marketing, Quality Assurance, and Manufacturing to ensure that Merit's products are available as soon as possible for shipment to the customer. • Enters fax & phone orders as needed. • Performs other tasks as required.

• Determines global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required. • Participates on various teams to define regulatory requirements of U.S. and international submissions, Technical Files or regulatory rationales. • Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation. • Prepares regulatory submissions to the FDA, the Notified Body and other regulatory authorities. • Prepares IDEs and PMAs and assists with clinical trials when required. • Interacts with various levels of management, external agencies and companies. • Analyzes and makes recommendations regarding field complaints. • Develops, maintains and analyzes department systems and provides training when needed. • Remains current on developing regulations and revises systems as necessary. • Participates in and assists with FDA facility inspections, Notified Body Audits and other inspections and audits as directed. • Assists with supervision of department staff, as directed. • Performs other related duties and tasks, as required.

• Develops and executes marketing strategy, plans, and forecasts. • Performs market research functions--including the collection, dissemination, and analysis of industry, medical procedures, competitor information, and market trends and opportunities. • Identifies new markets and growth opportunities and develops strategic business plan. • Manage product portfolio, including price analysis, new product launches, campaigns, etc. • Work with marketing communications to develop collateral for campaigns in brochures and general print media. • May manage department employees by interviewing, hiring, coordinating work assignments, training, evaluating work, disciplining, and other related duties. • Supports field readiness and execution for new product launches, including sales training, launch tools, and in field enablement. • Collaborates closely with Sales, Clinical, and Customer facing teams to support product adoption and implementation in the field. • Gathers and communicates field feedback, customer insights, and competitive intelligence to inform marketing strategy and product development. • Supports key opinion leader (KOL) engagement and field based educational initiatives, including meetings, events, and peer to peer programs.