Ocular Therapeutix, Inc.

Manager

• Support implementation of data dissemination plan for all programs via execution of the medical communication plan and incorporate strategic insights as relevant to medical
• Lead the execution of developing manuscripts, abstracts, presentations, and posters through collaboration with the medical communications team
• Collaborate with internal/external medical writers and/or vendors to draft, review, and edit medical and scientific content
• Provide support to internal/external authors and reviewers to track and facilitate content reviews, approvals, submissions, and other related activities as needed per ICJME guidelines
• Maintain the scientific communications platform
• Assist in the development of additional content for external audiences such as field medical, advisory boards, FAQs
• Shepherd medical materials through the review and approval process
• Coordinate and participate in MRC meetings to resolve comments and questions
• Manage reviewer timelines with close attention to deadlines, understanding sensitivities related to detail and timeline of information dissemination
• Create and maintain project status and projected timelines for medical and scientific materials
• Organize and maintain internal document and information repository with citations and references
• Develop broad and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with products and relevant disease states

Medical and Scientific Publications Manager

Marketing

• The Executive Director of ECP Marketing will help develop and analyze the treatment journey for retinal diseases and create a marketing strategy for ECPs.
• They will synthesize ECP and patient insights into actionable strategies to support patient Dx, treatment and ongoing support for associated retinal diseases.
• The Executive Director of ECP Marketing also has strategic guidance on all creative, messaging, platforms, tools, and resources focused on the treatment journey.
• This includes but not limited to selecting appropriate vendors, optimizing all aspects of internal operation, designing field facing campaigns, tools and resources that support Retina practices and patients throughout their treatment journey.
• The Executive Director of ECP Marketing collaborates with internal stakeholders (Market Access, Finance, Legal, Communications) to develop and launch relevant customer-facing support solutions.
• The Executive Director of ECP Marketing collaborates with external vendor partners and customers to ensure successful design, execution and utilization of tools and resources.

Executive Director, ECP Marketing

• Performs Lead CDM role for assigned studies
• Designs and/or assists with design of the clinical database based on protocol and study needs, including queries and dynamics
• Performs User Acceptance Testing (UAT) of the clinical database
• Authors, reviews, and approves study specific CDM documentation (DMPs, CCGs, DTAs, EDC specifications)
• Performs data cleaning activities for assigned studies; provide oversight of data cleaning activities for outsources studies
• Monitors study progress to ensure successful achievement of study milestones
• Provides oversight of CDM vendors for assigned studies
• Ensures that all CDM operations are conducted according to applicable SOPs
• Identifies and communicates potential risks/challenges to head of CDM and study CPM based on protocol, timelines, forecasts, and study metrics.
• Collaborates with the study team to identify, develop, and implement risk-based solutions
• Ensures CDM study documents are filed in the TMF (Trial Master File) in a timely manner
• May oversee tasks delegated to other CDM staff for assigned studies
• Performs other duties as required

Manager, Clinical Data Management

QA Engineer

• Plan and conduct audits of suppliers, investigator sites, and internal processes to assess compliance with the applicable regulatory requirements, guidelines, standards, agreements and / or Standard Operating Procedures.
• Write and distribute audit reports
• Collaborate with cross-functional teams to ensure timely resolution of audit findings and follow up on corrective and preventive actions (CAPAs).
• Manage audit scheduling, reporting, and tracking of audit activities, including audits outsourced to third parties
• Evaluate the design, feasibility, and operational integrity of clinical trial protocols
• Identify gaps or weaknesses in protocol implementation that could impact trial participant safety, data reliability, or regulatory compliance.
• Ensure consistent implementation, use and review of SOPs.
• Escalate issues to management in a timely manner implementing appropriate solutions, including preventive actions.
• Collaborate with internal cross-functional teams to improve quality and increase efficiencies.
• Support Ocular Therapeutix Quality Management System (QMS) by assisting with the development and updating of standard operating procedures and other controlled documents.
• Lead functional process improvement initiatives to drive efficiencies and effectiveness of Clinical Quality Assurance processes.
• Provide guidance and training on GXP regulations, corporate standards, and quality policies
• Provide support for inspection readiness and inspections
• All other duties as needed or assigned.

Senior Manager, Clinical Quality Assurance

• Oversee a multi-channel patient activation campaign
• Drive innovative messaging and campaign development
• Design patient marketing strategy and support tools
• Oversee patient marketing insight collection and analysis
• Design go-to-market engagement model for patients
• Engage with external customers to understand patient perspectives
• Manage reporting of performance analytics and insights
• Oversee KPIs of patient marketing tools
• Monitor market insights for continuous improvement
• Provide strategic direction on patient-centric programs

Medical and Scientific Publications Manager

Executive Director, ECP Marketing

Manager, Clinical Data Management

Senior Manager, Clinical Quality Assurance

Director, Patient Marketing