Lauren Maher Email & Phone Number

Center Valley, Pennsylvania, Us

Marlborough, Ma, Us

Marlborough, Ma, Us

Marlborough, Ma, Us

Marlborough, Ma, Us

Marlborough, Ma, Us

Marlborough, Ma, Us

Watford, Hertfordshire, Gb

• Develop and implement global marketing plans for arthroscopy knee products• Manage entire marketing process, including market strategy, product launches, product life cycle management, pricing, customer segmentation and position, competitive analysis, after-launch surveillance and obsolescence• Interface with cross-functional teams to ensure global revenue objectives are met• Analyze product costs and develop forecasts, and establish list pricing• Liaison with field sales management and consulting surgeons and other key opinion leaders to evaluate, validate and deliver marketing strategies and programs• Surgeon education and training

Boston, Ma, Us

Responsible for the coordination of regulatory submissions of new clinical trials in the MGH Cancer Center Protocol Office. Work with investigators, study staff, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies to ensure that regulatory requirements for clinical trials are met. • Independent work of completion and submission of new clinical trials applications to the IRB• Writing lay language and detail oriented informed consent documents• Tracking and facilitating the progress of new trials throughout the review process• Correspondence with the FDA, IRB, investigators, sponsors, and CROs throughout the review process• Collection, completion, and submission of regulatory documents to various regulatory entities• IND drug application submissions to FDA• Creation and maintenance of regulatory binders and other relevant files during review, approval, and activation process of new trials• Liaison and key contact to the Proton Radiation department• Oversee and maintenance of CALGB protocols between participating sites• Training and mentoring of new staff

•Responsible for U.S. and International compliance and quality activities and assisting in meeting various government regulations•Development and maintenance of FDA compliance related business processes, such as Adverse Event Reporting and Vigilance Reporting•Maintenance and release of device listings and facility registrations•Product Recalls and Health Hazard Assessments – from notification to FDA and customers to termination•Quarterly Medical Advisory Meeting – compile and present trending data •Assist in International Regulatory submissions and compilation of dossiers

- Addressed health administration issues of congressional committees Responded to concerns of constituents and boards - Reviewed health bills passed by committee members - Scheduled and performed research

Mba/Health Administration, Business Administration And Management, General

Bs, Business Administration; Management

Education record