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Directs the development, planning, implementation, and maintenance of Quality methods, processes, and operations for new or existing products and/or technologies. The QC group is comprised of the following functions: QC systems, Analytical Chemistry, Microbiology (including Environmental Monitoring), Method Validation, Stability and support. Provide strategic and tactical leadership to the Quality organization ensuring the execution of responsibilities within the Quality System.This position manages people and is responsible for all work completed within the QC group for pharmaceutical and medical device products across the entire product lifecycle.
Clinical research expert responsible for the co-development and execution of Medical Affairs scientific strategies spanning investigator initiated trials, clinical development studies (phase 1-4), and payer-informed research activities. Medical Directors contribute to the development of research questions, data analysis, interpretation, presentation, and publication of Ocular Therapeutix data across the Ophthalmology Scientific and Payer Communities.
The Clinical Document Specialist (CDS) will conduct clinical documentation tracking and trial master file activities. This position is highly visible and interactive with external vendors and cross-functional teams. In addition, the CDS plays a critical role in TMF management activities to ensure adherence to established processes and compliance with applicable global regulations.
Lead product lifecycle (development through discontinuation) compliance quality assurance activities to ensure Ocular Therapeutix processes are compliant against the applicable protocols, quality agreements and/or Standard Operating Procedures. Manage cGMP, cGCP and cGLP quality activities, Quality Data Integrity Reviews (DIR), Supplier Quality Management (SQM) and internal/external auditing program.
Responsible for managing and operating the business in an assigned geography and leading a team of Key Account Managers. Accountable for the successful execution of sales and marketing strategies. A successful candidate has demonstrated the ability to lead and to focus teams on business outcomes while fostering a positive environment and ensuring compliance. The Regional Director must develop a solid understanding of the market access situation for the company’s product(s) in order to be effective in coaching their KAMs and assisting customers directly.
Driven formulation scientist to support the R&D team in designing and developing novel controlled release drug delivery products, from ideation, to prototyping and proof of concept evaluation. The ideal candidate will be self-motivated, work with a sense of urgency, and have a strong foundation in sustained drug delivery and formulation development for injectable and implantable dosage forms.
The candidate will be expected to execute research and development activities as assigned by management, including prototype, product, and processes development and documentation. May oversee the execution of project tasks relevant to R&D and monitor the activities and deliverables of project teams when in a leadership role
The Validation Engineer-II shall support the validation activities associated with equipment, utility, facility and computerized system at Ocular including commissioning, and qualification (IQ, OQ and PQ). The validation engineer will also ensure the maintenance of the validated state, of all direct impact manufacturing systems used to support the clinical development and commercialization of multiple therapeutic drug substance platforms. The position is set in a dynamic, fast-paced start-up environment and shall require the individual to work on a broad range of tasks.
The validation engineer will also be responsible for generating risk assessments, authoring technical reports, assisting with factory and site acceptance testing of equipment or developing new procedures/methods.
The Medical Affairs Operations role will be an integral part of the Medical Affairs team. S/he will be accountable for executing logistical and operational tasks critical for cross-functional and department activities, including management of contracts, purchase orders and budget spend. S/he will manage the training materials for internal and external stakeholders, in partnership with Medical Communications. In addition, S/he will be responsible for team organization at conferences of all sizes, providing administrative support and assistance as needed. S/he will serve as the medical signatory on medical review of materials for promotional materials and non-promotional materials. This individual liaises with a variety of stakeholders across functions and is responsible for managing project deadlines and ensuring high quality documents are available for distribution to support the Medical Affairs team.
The Medical Statistician is an integral part of the Medical Affairs team, driving data generation and dissemination strategies across products and assisting in overall strategic planning. He/she will lead the development, coordination, performance, and validation of all statistical analyses in support of Medical Affairs, inclusive of overseeing the work of statistics and programming for external vendors as needed. He/she will also be accountable for working collaboratively with internal and external partners to apply statistical methodology to clinical trials across various trial phases and types, and act as lead statistician for key projects. Additionally, s/he will serve as the medical signatory on the internal promotional and medical review committees, ensuring all messages are medically accurate and appropriately cited. As an excellent communicator and collaborator maintain effective communication with clients, study teams, and other internal partners. Frequent cross-functional collaboration, both internal and external to the organization, is expected.
The Quality Systems Specialist II supports all activities within the Quality Systems team, including CAPA, Deviation and Change Control, and with a special focus on Document Control and Training. This includes, administering MasterControl, the electronic Document Management System (eDMS), supporting the document revision process, controlled document issuance, customer support, and establishment of training courses within the eDMS.
The Key Account Manager (KAM) is responsible for the successful promotion of approved products and helping define the Company as a leader within the ophthalmology community. This is done through development, cultivation and maintenance of long-term relationships with ophthalmic surgeons and all relevant personnel at ambulatory surgery center accounts. The KAM works on executing both clinical training of the product as well as understanding and assisting accounts with the reimbursement process to position products for rapid uptake. To accomplish this, successful performance will involve facilitating patient and provider access of product, and require the ability to help accounts understand and manage local payer reimbursement policies.
This role requires interaction with a variety of customers including; physicians (primarily surgeons), nurses, billing staff, administrators, financial personnel, i.e., any relevant stakeholder within ASCs and hospital outpatient departments. The KAM works with his/her assigned Area Sales Director and Reimbursement Manager to develop a local strategy and business plan that maximizes the opportunity across the assigned territory.
The Key Account Manager (KAM) is responsible for the successful promotion of approved products and helping define the Company as a leader within the ophthalmology community. This is done through development, cultivation and maintenance of long-term relationships with ophthalmic surgeons and all relevant personnel at ambulatory surgery center accounts. The KAM works on executing both clinical training of the product as well as understanding and assisting accounts with the reimbursement process to position products for rapid uptake. To accomplish this, successful performance will involve facilitating patient and provider access of product, and require the ability to help accounts understand and manage local payer reimbursement policies.
This role requires interaction with a variety of customers including; physicians (primarily surgeons), nurses, billing staff, administrators, financial personnel, i.e., any relevant stakeholder within ASCs and hospital outpatient departments. The KAM works with his/her assigned Area Sales Director and Reimbursement Manager to develop a local strategy and business plan that maximizes the opportunity across the assigned territory.
We are seeking an experienced and motivated R&D Engineer/Scientist to join our Drug Product Development Team. This individual is responsible for formulation, process development and scale-up of drug delivery candidates including the manufacture of preclinical and early phase clinical trial materials utilizing the company’s hydrogel-based drug delivery technology in concert with standard microencapsulation biodegradable polymer systems. In this role you will work collaboratively with group and cross-functional project team members and will oversee the execution of project tasks and activities when in a leadership role.
The Field Reimbursement Manager (FRM) is a regionally aligned, field-based position that provides reimbursement education and support for customers that utilize DEXTENZA®(and other future products) from Ocular Therapeutix. Customers may include Healthcare Providers (HCPs) within offices, ambulatory surgery centers (ASCs), hospital outpatient departments (HOPDs), and other appropriate site-of-care facilities as well as specialty pharmacies. The FRM will work closely with internal/external business partners including HCPs, billing and coding staff and other professionals involved in securing appropriate Access & Reimbursement for the use of DEXTENZA®.
The Manager, Calibration & Planning/Scheduling will be responsible for the management of the Metrology/Calibration Program and the Computerized Maintenance Management System (CMMS) in support of formulation, development and commercialization of innovative therapies at a GMP biopharmaceutical manufacturing plant.
The Key Account Manager (KAM) is responsible for the successful promotion of approved products and helping define the Company as a leader within the ophthalmology community. This is done through development, cultivation and maintenance of long-term relationships with ophthalmic surgeons and all relevant personnel at ambulatory surgery center accounts. The KAM works on executing both clinical training of the product as well as understanding and assisting accounts with the reimbursement process to position products for rapid uptake. To accomplish this, successful performance will involve facilitating patient and provider access of product, and require the ability to help accounts understand and manage local payer reimbursement policies.
This role requires interaction with a variety of customers including; physicians (primarily surgeons), nurses, billing staff, administrators, financial personnel, i.e., any relevant stakeholder within ASCs and hospital outpatient departments. The KAM works with his/her assigned Area Sales Director and Reimbursement Manager to develop a local strategy and business plan that maximizes the opportunity across the assigned territory.
The Field Reimbursement Manager (FRM) is a regionally aligned, field-based position that provides reimbursement education and support for customers that utilize DEXTENZA®(and other future products) from Ocular Therapeutix. Customers may include Healthcare Providers (HCPs) within offices, ambulatory surgery centers (ASCs), hospital outpatient departments (HOPDs), and other appropriate site-of-care facilities as well as specialty pharmacies. The FRM will work closely with internal/external business partners including HCPs, billing and coding staff and other professionals involved in securing appropriate Access & Reimbursement for the use of DEXTENZA®.
