The role involves executing high-volume outbound outreach through email, LinkedIn, and phone to schedule discovery calls and qualify business leads. Additionally, the representative will maintain accurate records in Zoho CRM and support pre-sales coordination to ensure a smooth handoff to Business Development Managers.
Lead and deliver GxP-focused consulting engagements across quality, regulatory, manufacturing, and clinical operations. Provide expert guidance on compliance readiness, regulatory inspections, and the optimization of quality management systems.
Lead and deliver GxP-focused consulting engagements as a subject matter expert across quality, regulatory, and manufacturing functions. Develop and optimize Quality Management Systems while providing expert guidance on compliance readiness and regulatory inspections.
Lead cell therapy research and development projects to advance novel cellular therapies for various diseases. Design and optimize manufacturing processes while collaborating cross-functionally to move programs from preclinical stages to commercialization.
The CRA will manage study maintenance and closeout activities, including data lock and budget monitoring. They will act as the primary liaison between internal study teams and external third-party organizations to ensure operational compliance.
Provide expert consulting and strategic advice to biopharmaceutical clients regarding biologics development, manufacturing, and regulatory compliance. Conduct gap analyses and support regulatory submissions such as INDs and BLAs to ensure client compliance and patient safety.
Lead gene therapy research and development projects from early discovery through clinical development. Design and optimize vectors and delivery systems while collaborating cross-functionally to ensure regulatory compliance.
Lead and manage cross-functional projects within pharmaceutical, biotechnology, and medical device environments. Develop project plans, timelines, and budgets while ensuring alignment with GxP and FDA compliance requirements.
Execute high-volume outbound outreach to business development leads and candidates via email, LinkedIn, and phone. Manage the recruitment and sales pipeline using Zoho CRM and Zoho Recruit to schedule discovery calls and interviews.
Provide expert consultation and support in bioequivalence study design and analysis to pharmaceutical companies and CROs. Review study protocols and prepare regulatory submissions to ensure compliance with guidelines.
Serve as a key point of contact for EU regulations and provide regulatory guidance for product development and commercialization activities. Collaborate with cross-functional teams to ensure alignment on regulatory strategy and stay updated on emerging regulatory trends.
Serve as the primary clinical expert within the organization, providing guidance across clinical development programs. Monitor ongoing clinical trials for protocol adherence and patient safety while collaborating with cross-functional teams.
Provide expert regulatory affairs guidance and support for biosimilars development projects. Collaborate with cross-functional teams to ensure alignment on regulatory strategy and objectives.
Lead and contribute to gene therapy research and development projects from early discovery through to clinical development. Collaborate cross-functionally with research, preclinical, clinical, and regulatory teams to advance gene therapy programs.
The Clinical Research Manager is responsible for the strategic and operational oversight of clinical trials, ensuring compliance with regulatory requirements and managing cross-functional teams. Key tasks include overseeing site selection, patient recruitment, and managing timelines and budgets.
Provide expert consultation and support in drug safety and pharmacovigilance to pharmaceutical companies and regulatory agencies. Review and evaluate adverse event reports and safety data for investigational and marketed drugs, ensuring compliance with regulatory requirements and guidelines.
Lead and provide expert guidance on CMC regulatory strategy and submissions for biologic products. Collaborate with cross-functional teams to develop and execute CMC regulatory strategies aligned with product development objectives.
Provide expert consultation and guidance on homeopathic treatments and remedies to clients. Develop personalized homeopathic treatment plans tailored to individual clients' needs and preferences.
The Clinical Data Manager is responsible for overseeing the integrity and quality of clinical trial data from collection through database lock. This includes designing CRFs, developing data management plans, and ensuring compliance with regulatory requirements.
Lead and contribute to cell therapy research and development projects, focusing on advancing novel cellular therapies. Collaborate with cross-functional teams to advance cell therapy programs from preclinical development through to commercialization.
Provide expert consulting services and strategic advice to clients in the biopharmaceutical industry, focusing on biologics development and regulatory affairs. Collaborate with clients to develop tailored solutions and conduct assessments to identify areas for improvement.
Lead and oversee quality management system activities for medical device products throughout the product lifecycle. Develop and implement quality and compliance strategies to ensure adherence to regulatory requirements and standards.
Support pharmaceutical manufacturing operations by applying engineering principles to optimize processes and equipment. Collaborate with cross-functional teams to ensure efficient and compliant manufacturing operations.
Lead and deliver GxP-focused consulting engagements while serving as a subject matter expert across multiple functions. Develop and optimize Quality Management Systems and provide expert guidance on compliance readiness and regulatory inspections.
The Contract Administrator will draft, review, and negotiate clinical study agreements and manage the end-to-end contracting process. They will collaborate with various internal teams to resolve contract issues and maintain organized records.
Lead and execute electrical design verification testing (DVT) activities for medical devices. Collaborate with cross-functional teams to resolve technical challenges and ensure compliance with quality and regulatory standards.
Lead end-to-end UX/UI design for medical device interfaces and digital tools. Collaborate with cross-functional teams to ensure compliance with usability and design control standards.
The R&D Engineer will lead and contribute to the entire product development lifecycle, ensuring compliance with regulatory standards. This includes developing designs, conducting testing, and collaborating with cross-functional teams to enhance product quality.
The Project Engineer will lead the planning and execution of medical device product development projects from concept through launch. They will coordinate all aspects of project planning, execution, risk management, and reporting while ensuring compliance with regulatory standards.
The Quality Engineer will ensure compliance with medical device regulations and global standards throughout the product lifecycle. This includes supporting design control activities, risk management, process validation, and maintaining the Quality Management System.
