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Communicates effectively with team members and key stakeholders on assigned program's progress, issues, risks, needs and opportunities.
Interacting with analytical scientists within and outside the company to ensure timely and accurate completion of activities.
Provide technical support to manage API process development and manufacturing activities.
Manage the effort to generate deep market, competitive and customer insights to inform brand strategy and tactics.
Identifying and analyzing legal and business issues and address them appropriately in contracts.
Manage communications with and provide oversight to partner companies, collaborative sponsors & respective CROs regarding the evaluation & processing of case reports.
Lead the medical safety group as well in product level safety governance (SMT) and communicate with VP Head of Safety for safety oversight.
Primarily responsible for clinical trial contract accrual GAAP accounting.
Define target audiences, behaviors, activation strategy, launch positioning and messaging for etrasimod.
Manage and support ongoing academic and industry collaboration studies; support portfolio projects through collaboration with investigators on proposals.
Oversee CRO activities relating to the preparation, negotiation and execution of agreements with clinical sites and investigators, and serve as primary liaison between CROs and legal team.
Draft regulatory documentation from approved sources; review regulatory documentation for consistency and compliance with guidelines.
Working with medical writing to develop and maintain standard text within templates, which may be company-wide or program specific; building and maintaining positive working relationships with key stakeholders, team members, and vendors.
Coordinating the compilation and writing of CMC sections for company's products for US, EU and Canada in compliance with applicable ICH, FDA and EMA guidelines.
Provides expertise on regulatory requirements and ensures assigned documents are produced in accordance with such guidance and relevant internal SOPs.
Create and execute annual publication plans for each product, incorporating scientific platforms, abstracts, posters, presentations, manuscripts and literature surveillance/library management.
Maintaining accurate documentation for all relevant support-related processes and procedures including updating systems and application technical standards, installation notes, and support procedures.
Significant experience conducting primary (qualitative and quantitative) and secondary market research with physicians, patients and payers across several therapeutic areas.
Ensure essential regulatory and administrative documents are processed accurately and in compliance; review and approval of monitoring reports.
Collaborate with clinical operations to support timely and on budget development and execution of the clinical program.
Collaborating with leading academic medical centers and foster relationships with thought leaders, investigators and study personnel.
Establish plan for data quality control, including consistency and accuracy of data collection, edit checks, data query management, and quality audits.
Collaborates with the programming and data management, functions to ensure data collection and reporting is done in conformance with ongoing practice and regulatory expectations.
Manages final archival of data management documentation, and assists Clinical Trial Team in assembling and archiving the documentation.