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The Scientist II, Analytical Development is responsible for performing and supporting analytical testing, method development, and optimization for drug substances and products. This includes analysis using techniques such as HPLC and GC, collaborating with cross-functional teams, maintaining laboratory records, and ensuring compliance with regulatory standards and operating procedures.
The Senior Manager, Quality Assurance - GxP (GCP) ensures compliance with GCP regulations by managing QA functions, conducting audits, and supporting inspection readiness. They work collaboratively with clinical teams, lead audit activities, and oversee quality management processes, while also mentoring direct reports.
The Senior Scientist in Analytical Development develops and validates analytical methods for drug products, coordinates testing and documentation for regulatory submissions, and collaborates cross-functionally on analytical issues, while ensuring compliance with regulatory standards. The role also involves troubleshooting techniques and overseeing stability studies.
The Senior Manager, Statistical Programming leads programming activities for clinical studies, ensuring timely analysis of clinical data, developing statistical programs, and coordinating with CROs. They participate in team meetings, review CRFs and statistical plans, and may create standard operating procedures related to statistical programming.
The Senior Manager, Quality Assurance - GxP (GCP) oversees GxP Quality Assurance functions, emphasizing Good Clinical Practice compliance. Responsibilities include conducting internal and external audits, leading inspection readiness activities, managing direct reports, and ensuring adherence to regulatory requirements and company SOPs.
The Contract TMF Specialist is responsible for collecting, reviewing, maintaining, and archiving regulatory documents for the Trial Master File (TMF) in compliance with GCP, ICH Guidelines, and relevant regulations. They work with various teams to ensure TMFs remain inspection-ready, track document expiration dates, upload TMF documents, provide oversight of CROs, and assist during audits.
The Market Access Regional Account Manager is responsible for gaining and maintaining access and reimbursement for PTC Therapeutics products across key regional payers. The role includes establishing relationships with pharmacy and medical decision makers, executing business plans, and collaborating with internal teams to address market access issues and drive sales success.
The Market Access, Regional Account Manager develops and maintains relationships with key regional payers to ensure access and reimbursement for PTC Therapeutics products. Responsibilities include collaborating cross-functionally, optimizing business performance, and adhering to regulatory standards while engaging with internal and external stakeholders to enhance patient services and market strategies.
The Market Access, Regional Account Manager is responsible for achieving broad coverage and reimbursement for PTC Therapeutics products by collaborating with regional payers and internal departments, developing business plans, and providing insights into market trends and changes in policies.
The Lead of US Pricing and Contracts Operations oversees pricing strategies and contract management operations. This role involves managing the contract lifecycle, ensuring compliance, conducting financial analysis, and collaborating with cross-functional teams. The individual is responsible for developing standardized processes, enhancing operational efficiency, and supporting revenue optimization.
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