Author and manage regulatory documents such as Clinical Study Reports and protocols while leading document development efforts. Serve as a project owner by coordinating timelines and collaborating with cross-functional teams to ensure submission readiness.
Syner-G
21 Remote Job Openings at Syner-G
The Sr. Revenue Accountant is responsible for ensuring accurate revenue recognition and billing in compliance with ASC 606 for complex consulting arrangements. This includes managing accounts receivable, performing monthly reconciliations, and partnering with cross-functional teams to resolve contractual and invoicing issues.
Lead the planning, coordination, and execution of capital projects including facility expansions and infrastructure upgrades. Manage project scope, budgets, and risks while coordinating between internal teams, contractors, and client stakeholders.
Design and develop stable formulations for high concentration subcutaneous dosage forms and optimize lyophilization processes. Manage the transfer of designs to CDMO partners and prepare regulatory submissions such as INDs and CTAs.
The Validation Engineer is responsible for developing and executing validation protocols (FAT, SAT, IOQ, PQ) for processes, equipment, and facilities. They drive overall quality performance and compliance by maintaining the organization's validation program and supporting tech transfer projects.
Oversee the design, validation, and execution of analytical methods for oligonucleotides and peptides while managing transfers to CDMO partners. Collaborate with CMC teams to prepare regulatory submissions and ensure compliance with FDA, EMA, and ICH guidelines.
Provide advanced organizational and administrative support for construction and maintenance projects with a heavy focus on health and safety. Act as a facilitator between project managers, contractors, and stakeholders to ensure regulatory compliance and efficient project execution.
Guide clients through regulatory affairs and clinical development to ensure successful pharmaceutical product approval. Oversee the preparation and submission of clinical regulatory documents and lead communications with the FDA and global authorities.
The role involves guiding clients through regulatory affairs, overseeing the preparation and submission of clinical and non-clinical documents to the FDA. Additionally, it entails leading the implementation of digital validation platforms like ValGenesis or Kneat within regulated pharmaceutical environments.
Oversee project execution with a focus on clinical supply operations, including managing goals, budgets, and resource allocation. Lead project teams and maintain strong relationships with clients and vendors to ensure timely delivery of clinical supplies.
Lead GCP quality and compliance engagements for biopharma clients, overseeing CROs and vendors to ensure inspection readiness. Establish sponsor oversight programs, conduct GCP audits, and advise on regulatory strategy across the clinical development lifecycle.
Lead the delivery of continuous improvement and organizational change frameworks to help clients adopt sustainable business excellence processes. Serve as a strategic partner to client leadership to translate strategic objectives into actionable operational goals and transformation roadmaps.
The role serves as the global regulatory point of contact for designated products, leading life-cycle management and the execution of global regulatory submissions. It involves managing agency communications, coordinating labeling updates, and collaborating with cross-functional partners to ensure regulatory alignment.
The Vice President of Regulatory Partnerships will lead and expand strategic regulatory partnerships with a focus on post-approval lifecycle management and integrated client solutions. This role involves driving revenue growth, managing global teams, and ensuring operational excellence across regulatory consulting and service lines.
The Sr. Fill-Finish Process Engineer will support the design, construction, and qualification of new commercial fill-finish suites while serving as a subject matter expert for aseptic manufacturing processes. They will collaborate with cross-functional teams to ensure technical troubleshooting, process optimization, and strict adherence to GMP and regulatory standards.
The Sr. Fill-Finish Process Engineer will support the design, construction, and qualification of new commercial fill-finish suites while serving as a subject matter expert for aseptic manufacturing processes. They will collaborate with cross-functional teams to ensure technical troubleshooting, process optimization, and strict adherence to GMP and regulatory standards.
The Senior Process Engineer will lead process optimization for oral solid dose manufacturing and support technology transfer activities. They will troubleshoot complex process issues and collaborate with various teams to implement sustainable process improvements.
The Facilities Technician III is responsible for performing advanced maintenance activities and troubleshooting complex issues across multiple building systems. This role also includes supporting reliability and compliance requirements in laboratory, manufacturing, and utility environments.
This role involves leading the strategic planning, development, and execution of the company’s AI roadmap and long-term innovation strategy, focusing on identifying and prioritizing opportunities to improve operations and business value. Key functions include overseeing the entire AI development lifecycle, implementing responsible AI frameworks, building and mentoring a high-performing AI organization, and communicating complex technical insights to executive leadership.
This role is responsible for leading territory strategy, driving new business generation, expanding existing accounts, and managing high-value client relationships across multiple regions and service lines. The Director will partner with internal teams to shape proposals, negotiate contracts, and drive overall revenue growth.
The role involves providing regulatory consulting to a global pharmaceutical client, focusing on Chemistry, Manufacturing, and Controls (CMC) for post-approval products to ensure compliance with FDA, EMA, and global regulations. Key duties include leading the authoring and review of global CMC submissions, executing regulatory strategies, and coordinating responses to health authority questions.
