Jobs in All Categories (26) Accounting & Finance (3) Engineering & Construction (2) Marketing, Media & Design (1) Operations & General Management (3) Science & Education (14) Technology (3)
Collaborate with the Sr. Director Supply Planning to set the strategy for analytics, reporting and global supply planning as well as budget reporting.
Collaborate with internal teams, CROs and external vendors to prepare, review and finalize clinical protocol documents.
Performing statistical analysis, generating analytic reports, tables, figures, and slides in support of clinical study and other reports.
This position will have responsibility for the quality assurance oversight of manufacturing operations at company's CMO including the review of batch records and product release.
Manager, Process Chemistry will have responsibility for the management of API and solid oral dosage manufacturing operations at Insmed's CMOs .
Support the Commercial Leadership team in annual Business Planning Process, including proactively working on risks and opportunities related to revenue and investments.
Provide technical expertise in their area of specialization (i.e., Inhalation Devices, Device Development, etc.).
Review/revise Data Management related study plans including Data Management Plan, Data Validation Plan and other study documents to ensure quality and standardization.
Contribute to the strategic IT Launch roadmap to build Commercial capabilities in CRM, Case Management for Patient Services, Sales Roster, Incentive Compensation, Reporting and Master Data Management.
Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development as appropriate.
Work closely with medical and clinical leadership and other cross functional partners and outside vendors in order to effectively execute key commercial activities.
Retain secure access to the US Medicare database and conduct data and analytic evaluations following an approved study protocol.
Analyze cost savings opportunities, develop project plans and monitor progress and results .
Responsible and oversight for PV inspection readiness activities and quality in collaboration to company Quality Assurance.
The Medical Science Liaison develops and maintains professional relationships with external healthcare practitioners to provide comprehensive medical and scientific support for company assigned therapeutic areas.
Reviews current policies/practices and guidelines issued by Federal regulatory agencies and update management as needed.
Lead a motivated and focused team aligned with the organizational goals of the Research Department and with Company policy.
Working with the Executive Director, Corporate Compliance, Policies and Training, on designing auditing and monitoring programs to ensure robust implementation of corporate compliance policies and training.
Oversight of the development and implementation of compliance policies and procedures with input from all relevant stakeholders.
Participates in meetings to identify data collection instruments and database design requirements to ensure that the data evaluated are free of bias, contain maximum information, and satisfy analysis requirements.
Assist staff the medical information booths at conferences to provide unsolicited medical information to healthcare providers.
Monitor delivery of approved results in accordance with Quality Service Agreements.
Able to work in a fast-paced, team-oriented environment to accelerate early drug development.
Interacts with internal partners, CMOs and contract laboratories during the technology transfers of analytical methods, clinical batch testing, stability testing and CMC compilation of assigned projects.
Manage and oversee analytical method development in support of drug development.