Kelly Services is seeking a fulltime Customer Service Associate for one of their client to be part of their team and an asset to the company's USA organization. Ideal Customer Service Associate will have experience in medical device research is preferred, includes responsibility for coordinating and managing all aspects of clinical and commercial activities to maintain regulatory compliance and meet company timelines and goals for the clinical development program.
PRIMARY JOB FUNCTION:
The position reports directly to the Vice President, and oversees all domestic sales support and logistics functions for both Sales Leadership Team as well as the Independent Distribution Network in the USA.
Essential Duties and Responsibilities:
Operations and Sales Support
Need to have the ability to learn the clinical disease states need answer surgeon questions related to product usage
Be able to comply to regulations of regulatory bodies
Manage process flow definition for ERP integration projects
Use of CRM for development into Exact ERP system
Work with Exact ERP to process orders and invoices
Manage Instrument sets/units for on-boarding new surgeons/hospitals
Conduct thorough analysis of customer inventory levels in comparison to sales volume
Proactively monitor inventory levels in partnership with the sales team and internal departments
Manage excess inventory and monitor to ensure product is received
Resolve errors and/or discrepancies with regards to inventory with Customer Service, Field Auditors, and with customers as needed
Follow appropriate procedures and ensure customers are in compliance, from an inventory standpoint
Provide information on inventory levels and usage for the sales team
Distribution of sales reporting & analytics.
Work with sales management team to develop the quarterly sales forecast and coordinate with operations to assure that inventory is available to meet requirements
Monitor ongoing sales trends
Actively participate in development and implementation of sales programs, and all other development projects that relate to field execution
Coordinate contract agreement process including creation, revision, and execution of documents
Hospital pricing quotes & contract pricing administration
Perform research to support presentations and preparation of presentation data for sales team
Assist in operational management of relationships with distributor partners
Develop and distribute necessary contract agreements in conjunction with the company's USA legal team for all distribution partners
Manage distributor price lists
Distributor database management
Manage and execute distributor on-boarding process, including contracts, demo starter kits, marketing collateral and all on-boarding forms
Liaise between USA / EU team, distributor partner, and internal operations team to effectively integrate distributor partner into the USA Distribution Network
Serve as main point of contact for distributor partners
Assist with annual physical field consigned inventory process
Provide support to clinical accounts
May include the need to organize investigator-s start-up meeting and study site initiation meetings.
Ensure procedures are in place for appropriate optimization of patients into the clinical trial.
Monitoring the assigned clinical trial following company SOPs and in accordance with GCP.
Planning the requirements for clinical trial material, ordering clinical trial material (head office or local comparators), setting up and monitoring the systems whereby the Clinical Research Assistant can ship material to the investigator, maintaining procedures to account for the material, checking the expiration of material and requesting extensions if necessary.
Be the point of first contact for customers and surgeon or site personnel inquire about patient inclusion/exclusion criteria for ongoing trials.
Participate in global conference calls and meetings to review progress of ongoing clinical trials.
Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion.
Manage patient recruitment strategies to increase patient randomization into the trial (eg. investigator and research nurse meetings, update newsletters, advertising, letters to GPs).
Be able to travel and represent the company and the products.
Conduct product training and attend conferences in the United States and internationally?
Assist in preparing study related reports;
1. File and archive study related documents;
2. Ship and receive study related devices and documents;
3. Perform internal and external study related audits;
4. Working knowledge of the study protocols and procedures;
5. Working knowledge of Good Clinical Practice and US FDA regulations related to medical device clinical studies;
6. Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
7. Complete submissions to FDA, EU regulatory entities.
8. Create and maintain product EU technical files.
9. Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.
QUALIFICATIONS / REQUIREMENTS
Customer Service Experience in optometry, medical devices or biotechnology.
Bachelor's degree is a plus, or equivalent experience;
Approximately 10% - 15% travel is required;
Proficient knowledge of Microsoft Office;
Excellent communication and organizational skills;
Attention to detail and a high degree of accuracy with respect to study documentation and data collection;
Customer Relationship Management
Resolve Customer Issue
Explain Product Feature
Promote Customer Loyalty Plan