Merit Medical Oncology

QA Engineer

• Executes supplier development engineering for the Company’s supplier base
• Works with manufacturers and service suppliers to ensure product / services provided meet company requirements
• Interfaces with other departments as well as with suppliers and other external parties on issues related to product manufacturability and product changes
• Plans, organizes, directs and reports on all engineering supplier development activities such as raw materials changes, contracted designed and manufactured items, packaging materials, service providers, and laboratories to assure procurements meet or exceed the requirements
• Works directly with the Company manufacturing plants and the contract manufacturer to integrate the incoming performance of raw material and component supplier to collaboratively resolve issues
• Assures that customer technical requirements are adhered to by supplier and that a quality system is maintained
• Develops procedures for supplier management to establish world class supplier processes
• Conducts programs designed to improve supplier performance, productivity, and process validation
• Supports quality issues through Supplier Corrective Action Reports as needed and provides assistance to develop corrective actions in an effort to reduce and eliminate defects
• Manages cost savings initiatives with suppliers through integration into Merit manufacturing facilities
• Manages supply chain resiliency programs which include but are not limited to supplier consolidation, dual sourcing, acquisition integrations
• Responsible for ensuring that the cost savings initiatives and supply chain resiliency programs are communicated effectively to senior leadership
• Develops reports on supplier performance for company management
• Liaises between corporate and manufacturing sites for the deployment and communication of needs and new or improved requirements

Senior Supplier Quality Engineer

Medical writer

• 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.

Senior Medical Writer

Procurement

• Determines production requirements and dock dates by running shortage reports and communicating with production planners.
• Obtains appropriate signature levels for purchase orders; prepares the order through the ERP/MRP/EPO system.
• Expedites materials from suppliers to ensure on-time delivery.
• Works with the Quality Assurance and Engineering departments to verify the accuracy of Non-Conforming Material Reports before returning materials to suppliers.
• Obtains corrective action reports from suppliers to ensure that quality problems are resolved in a timely manner.
• Supports the Engineering and Manufacturing departments on new product requirements to ensure that program deadlines are met.
• Attends scheduled production planning and engineering meetings.
• Provides monthly purchasing reports.
• Supports production teams, as required.
• Reviews supplier contracts and ensures Suppliers are meeting the negotiated service levels and agreed pricing.
• Evaluates vendor price increases. Works with management in obtaining new negotiated pricing and service levels.
• Meets with suppliers and manufacturers' representatives to obtain information concerning pricing, quality, availability and delivery of parts.
• Evaluates Engineering Change Notices for cost or delivery impacts and to coordinate implementation of changes with suppliers.
• Assists with supplier selection and set up.
• Performs other tasks, as required.

Procurement Agent II

Account Manager

• 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.

Territory Manager

• 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

Territory Manager – Vascular Interventions

Compliance

• 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.

Senior Regulatory Affairs Specialist

Marketing

• 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.

Field Marketing Manager

Accounting Manager

• Reconcile general ledger accounts.
• Perform accounts payable functions.
• Assist in closing financial records.
• Document process and transaction flows.
• Performs a variety of related tasks, as required.

Accounting Intern

Manager

• Provides clinical training to various groups such as Sales Representatives, Tech Teams, Merit employees, Cath lab and Radiology staff, and physicians on all Merit products.
• Demonstrates mastery, competence, and expertise with all assigned products within the CI/PI verticals and associated therapeutic procedures.
• Leads in organizing and overseeing the on-site or remote clinical aspects of product related account trials or conversions.
• Operates within the clinical applications team, acting as the main clinical resource for the assigned products.
• In-service, guide, and clinically support customers on new and existing products, training and in-servicing at accounts’ locations ~50% of the time.
• Assist in the assessment of new product market research trials in the field (CPE’s) and new product introductions.
• Provide ongoing product related instruction to customers and offer relevant product information.
• Address clinical inquiries from doctors, technicians, sales representatives, and other relevant parties.
• Integrate into the clinical and regional teams to become a value-add contributing member.
• Perform other duties and tasks, as required.

Clinical Development Manager – Vascular

• Assists with guidance and training support for StatSeal product-based knowledge to all related customers internal or external.
• Territory includes Florida, Georgia, Alabama, Mississippi, and Southern North Carolina.
• Demonstrates mastery, competence, and expertise with all assigned products within the CI/PI verticals and associated therapeutic procedures.
• Leads in organizing and overseeing the on-site or remote clinical aspects of product related account trials or conversions, including documenting and tracking of comments, opportunities and projects in CRM.
• Operates within the clinical applications team, acting as the main clinical resource for the assigned products in the assigned region, as well as a resource for other team members and providing assigned mentorship to peers.
• In-service, guide, and clinically support customers on new and existing products, training and in-servicing at accounts’ locations ~50% of the time.
• Assist in the assessment of new product market research trials in the field (CPE’s) and new product introductions.
• Provide ongoing product related instruction to customers and offer relevant product information.
• Address clinical inquiries from doctors, technicians, sales representatives, and other relevant parties.
• Integrate into the clinical and regional teams to become a value-add contributing member.
• Acts as clinical product related resource to customers and sales teams.
• Perform other duties and tasks, as required.

Clinical Development Manager, Vascular

• Deliver approved comprehensive training and education programs that provide customers and personnel with up-to-date information on company products, procedures, and best practices.
• Deliver approved content during didactic portions of training.
• Provide case support to trained customers (domestic and international) as part of Merit's commitment to the safe and efficacious use of products.
• Conduct assessments to ascertain the skill level and ability of those being trained, and develop training curriculums and programs to improve knowledge, skill, and ability.
• Defines protocol and assists in the field assessment of new product market research trials (MRT’s).
• Develops and implements ongoing home-study training courses to improve and maintain a high level of product and clinical expertise in the field sales organization.
• Conducts ongoing staff training and provides clinical feedback to resolve customer-related issues.
• Serves as a clinical expert for the company.
• Standardizes & computerizes (digitalizes) sales training materials.
• Works with Product Managers to develop sales training and in-servicing videos.
• Answers clinical questions from doctors, technicians, sales representatives, etc.
• Supports sales and marketing efforts by in-servicing key customers on Merit products.
• Works in the field to support and train clinicians on the use of Merit products and troubleshoot product-related issues in the field.
• Assesses clinical competency of new employees and provides comprehensive feedback and recommendations for improvement.
• Writes technical papers to support new emerging markets, segments, and niches.
• Assists in coordinating and executing Symposiums and other clinical education events.
• Develops value-added CEU credits to augment sales effort.
• Performs other duties and tasks as required.

Clinical Training and Education Manager, Endoscopy

Account Executive

• 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.
• 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.

Account Executive, Oncology

• Assists with guidance and training support for product-based knowledge to all related customers internal or external.
• Demonstrates mastery, competence, and expertise with all assigned products within the CI/PI verticals and associated therapeutic procedures.
• Leads in organizing and overseeing the on-site or remote clinical aspects of product related account trials or conversions.
• Operates within the clinical applications team, acting as the main clinical resource for the assigned products in the assigned region.
• In-service, guide, and clinically support customers on new and existing products, training and in-servicing at accounts’ locations ~50% of the time.
• Assist in the assessment of new product market research trials in the field (CPE’s) and new product introductions.
• Provide ongoing product related instruction to customers and offer relevant product information.
• Address clinical inquiries from doctors, technicians, sales representatives, and other relevant parties.
• Integrate into the clinical and regional teams to become a value-add contributing member.
• Acts as clinical product related resource to customers and sales teams.
• Perform other duties and tasks, as required.