Veristat

Medical writer

• Prepare high-quality regulatory documentation for client submissions
• Contribute to authorship of documents across different service lines
• Lead projects and author regulatory documents for client engagements
• Mentor others in regulatory document authoring
• Author and lead Modules 3 and Module 2.3
• Serve as document lead for submission-level documents
• Provide subject matter guidance on document preparation, review, comment resolution, and finalization
• Lead project teams toward goals within timelines and budgets
• Build professional client relationships and support business relationships
• Identify and institutionalize effective work practices
• Resolve sensitive or high-pressure project problems
• Transfer knowledge across the organization

Principal Medical Writer – CMC Focus

• Prepare high-quality documentation for regulatory submissions to streamline the regulatory documentation process for clients
• Contribute to authorship of various documents across different service lines
• Lead projects and contribute as an author for all types of client engagements
• Mentor others in authoring regulatory documents
• Lead submission-level sections for clinical documents, including Clinical Study Reports, Protocols, Investigator Brochures, ISS and ISE
• Lead sub-teams for pharmacovigilance and transparency and disclosure deliverables
• Take responsibility for clarity of purpose and lead others toward common goals within timelines and budgets on complex projects
• Manage crisis communications and risks
• Identify and promptly address potential problems, particularly in sensitive or high-pressure situations
• Integrate expertise across multiple therapy areas to deliver business successes and transfer knowledge across the organization

Principal Medical Writer – Clinical Focus

Security Analyst

• Serve as the organization’s primary internal coordinator for cybersecurity procedures, monitoring, reporting, and continuous improvement
• Oversee the managed service provider’s security services
• Review the MSP’s work and recommendations
• Coordinate internal responses and ensure identified risks and required actions are addressed
• Manage recurring security reviews, reporting, incident and vulnerability follow-up, documentation, and customer security audits
• Present security findings, risks, and recommended strategies to senior management, customers, and internal staff
• Support the CIO and IT Manager

IT Security Analyst II

• Independently plan and prepare a range of regulatory documents and medical communications supporting all phases of product development.
• Organize, analyze, interpret, and present scientific and statistical information in accordance with ICH and other regulatory guidelines and company document standards.
• Work under the direction of Medical Writing management.
• Collaborate with cross-functional internal and external document production teams.

Principal Medical Writer

• Independently plan and prepare regulatory documents and medical communications supporting all phases of product development
• Organize, analyze, interpret, and present scientific and statistical information
• Ensure documents comply with ICH, other regulatory guidelines, and company document standards
• Work under the direction of Medical Writing management
• Collaborate with cross-functional internal and external document production teams

Senior Medical Writer

Clinical Research

• Perform data management tasks from study start-up through database lock for assigned clinical research projects
• Manage paper-based and electronic data capture (EDC) studies
• Ensure overall data quality and documentation on clinical research projects
• Work on mid-to-large complex projects across various indications
• Serve at times as program manager overseeing multiple studies for the same client
• Lead a team of clinical data managers to ensure contracted activities follow Veristat Standard Operating Procedures and/or sponsor-specific requirements
• Promote consistent operations, efficient resource use, knowledge sharing, and best practices with Data Management leadership
• Assist with training data managers on project-specific and general data management processes, procedures, and systems
• Provide training to other company functions as needed

Principal Clinical Data Manager

Manager

• Manage Veristat’s vendor lifecycle end-to-end, from vendor identification and proposal support through selection, qualification, negotiation, and contract execution.
• Lead global strategic sourcing and procurement activities, including activities supporting clinical trials conducted for Veristat’s sponsors.
• Develop and maintain relationships with contracted vendors.
• Serve as a key point of contact for vendor performance concerns and escalations.
• Establish and maintain vendor performance measures, including KPIs and scorecards.
• Monitor vendor performance and market trends.
• Evaluate new and emerging vendors to maintain a strong, competitive, and high-performing vendor network.

Vendor Manager

Associate

• Process and manage serious adverse events
• Oversee study patients’ safety matters
• Work closely with other departments, sponsors, and investigator sites
• Ensure proper plans are in place to appropriately collect and report Adverse Events (AEs) and Serious Adverse Events (SAEs)
• Facilitate the development and implementation of training programs for internal and external personnel managing safety information
• Assist the department head in managing relevant safety group activities