Liaise across functions on market access, pricing & reimbursement and registration (for Patient Reported Outcomes) evidence requirements to provide strategic input across the product lifecycle in order to optimize product utilization.
Support all aspects of business development process including target identification, business case development, due diligence, deal structuring, negotiations and transition planning.
Lead Development of tools and reports to analyze supplier spend activity, compliance, risk, cost savings opportunities, identify and prioritize sourcing projects, and long-range planning inputs to the overall process to ensure accurate pipeline and supplier project visibility.
The ideal candidate will have a strong understanding of databases and data analyses procedures, be tech-savvy and possess excellent troubleshooting skills.
The role is both business and technical focused requiring a strong technical level understanding of Sales Operations applications, Veeva CRM, Master Data Management tools, Qlik for Sales Reporting/Analytics.
Analyze and monitor reports from MMIT, Shyft Analytics (Specialty Pharmacy dispense data) and any other identified data source (at least quarterly) for Market Access Key Account Directors and Gross-To-Net Financial Operations team.
The Clinical Research Scientist (CRS) will support and work predominately with the Medical Monitor for assigned protocols and/or projects, partnering with vendors and cross functional teams.
Effectively manages the cross-functional study team to achieve deliverables with high quality, on time and within budget through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management planning.
Provide Regulatory direction for the coordination, and preparation of Regulatory submissions consistent with Regulatory requirements to meet corporate strategy & timelines.
Business partner to global Technical operations and Contract Manufacturing Organizations (CMO's) and Contract Packaging Organization (CPO) key contributor to the Sales and Operational Planning (S&OP) process.
This position will be responsible for SAS programming and statistical analytics for HEOR scientific evidence development in support of Insmed product value propositions to address stakeholder evidence requests.
The successful candidate is responsible for the complete preparation, including but not limited to, the writing, reviewing and editing of protocols, Investigator Brochures (IBs), clinical study reports (CSRs), and Summary Modules for Regulatory Submissions.
Involved in early development planning of development strategies to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
Communicating deviations identified through monitoring to the business, and providing it with tailored remedial training and/or suggested process/procedural changes to help prevent further deviations.
Leadership role within a cross functional team of medical professionals in planning and executing all aspects of the integrated medical affairs plans for ALIS.
Identify opportunities to enhance performance; e.g. secondary data analysis for business insights (source of business, national / sub-national analytics), key prescribers, patient start and treatment adherence trends, resource allocation.
Leadership role within a cross functional team of medical professionals in planning and executing all aspects of the integrated medical affairs plans for ALIS.
Track Market Access/Payer account landscape coverage pre- and post-launch, based on lives, level of control, prevalence/diagnosis rates, reversal/rejection rates, etc.
Execution of the global scientific communications tactical plan. Ensures the timely dissemination of scientific data to a diverse healthcare professional audience, maximizing the communication of the latest data and the unmet medical need of the relevant disease areas.
Ensures the publication development process and all materials produced are in compliance with current relevant guidelines including, but not limited to, the ICMJE, PhRMA, and GPP3. Develops and maintains relevant SOPs and guidance documents.
Responsible for the oversight of tech transfer and manufacturing operations at CMOs. This includes the introduction of appropriate process manufacturing engineering and technologies required to increase robustness and reproducibility of manufacturing processes. This is to be achieved by leveraging the process expertise within Insmed and our contract partners.
Critically review documents produced by external writers for scientific content and alignment with company position, clarity, accuracy, and consistency.
Annual Report