I’m a Veteran Life Sciences professional combining 16 years’ experience in the pharmaceutical industry and 10 years of clinical experience. Pharmaceutical industry experience includes working for Big Pharma to medium size companies. Areas of strength include leadership, case processing, quality review, SOP development, vendor management, and creating and maintaining both internal and external relationships. I possess an uncanny ability to analyze the overall picture, identify gaps, and create solutions. I am a positive leader who is passionate about people, with…

Long history of site management and clinical site excellence.

Lead scientific teams in the development and implementation of clinical outcome assessments (COAs) to support regulatory, payer, and communication strategies for pharmaceutical industry clients. • Expertise in qualitative research, including patient and expert concept elicitation and cognitive debriefing interviews, to support initiatives in endpoint development and outcomes assessments. • Provide support in the optimal selection of COAs to evaluate treatment benefit. • Articulate, as well as execute, the regulatory steps for clients when submitting Type C Meeting requests, developing briefing…

Clinical Research professional with extensive knowledge of clinical study design and CRO collaboration. A natural leader with exceptional technical, creative, and interpersonal skills. A passion for optimizing clinical trial processes through motivating and directing others. Proven ability to predict issues at the early stages of a project. Unique talent to quickly identify problems during the conduct and elevate data-driven insights to mitigate risks. Unmistakable professional integrity and commitment to excellence.

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Specialty: Pharma/Med Device quality remediation projects • Extensive experience in government (Food and Drug Administration)/ DEA industry, quality assurance and regulatory, notified body, US, and foreign pharmaceutical manufacturing/medical devices. • Knowledge and skills in ISO 13485, 14971, QSR GMP 820, ICH, MDR, Eudralex Annex 1, CGMP 210/211, HCT/P, AATB, FDA 1271, AABB, EMEA/MHRA Audit, Quality Mgmt. Systems, Risk-Based Auditing, Inspection Readiness, QualityControl, Investigations, Root Cause Analysis, Preventive Maintenance, Complaints/HHE, Deviations, Supplier/ CMO Quality and Agreements, Supplier Auditing, CAPAs, Data Integrity,…

MedLitera is a small, specialized virtual firm that provides high-quality medical and health economics writing services. When you work with MedLitera, you have access to the expertise of a group of professionals whose range is a unique strength. Our writers, editors, and researchers are versed in both the clinical and economic aspects of health care. MedLitera can tailor your project to the appropriate audience. We are comfortable writing for specialists and primary care physicians, pharmacists, and other healthcare professionals. We…

I am a highly accomplished leader and innovator with over 25 years of the proven track record of R&D in immunology, oncology, and experimental medicine. Metrics focused, innovative problem-solver with extensive experience directing research spanning all aspects of scientific discovery: from conception through preclinical development and translation to a clinical setting.

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I have exceptional expertise in preparing and compiling regulatory submissions, formatting complex documents, developing business process documentation, managing and leading Regulatory Operations teams, and providing up to date regulatory submissions recommendations and advice. I possess a solid reputation for never missing a project timeline, being able to multi-task successfully, and being extremely organized, responsive, and resourceful.

Thorough knowledge of our clinical trial ecosystem. An ability to lead and create the conditions of the successful delivery of your program(s) using advanced technologies.

Virtual CIO – on demand/as needed  Mentoring & Advising  Interim Information Technology management  IT Department formation, evaluation, organization  IT budgeting & benchmarking  IT RFP management and review  IT contract review  IT readiness for legal hold processes and eDiscovery  IT support for mergers & acquisitions  Systems selection, implementation, validation and stabilization

Established clinical research professional with 20 years of research experience on both the operational and business sides of the clinical research industry from the investigative site, clinical research organization (CRO), and sponsor perspectives. Strengths include excellent interpersonal skills, positive attitude, ability to play multiple roles in a team, and keen attention to detail.

Expert data management problem solver specializes in EDC/CDM, reporting, dashboards, data integration, and implementation.

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.For the past 19+ years I have had numerous roles of Regulatory experience. I have provided Regulatory consultation to top tier Pharmaceutical and Biotech companies and submitted numerous Original and Lifecycle applications to FDA and EMA. As a core member of the CSC Regulatory Operations Team, I have managed several different groups to exceed client expectations while meeting vigorous timelines, and continuously striving to improve internal and external process flow to maximize utilization rate and to optimize client relationships.

Expert on all things RIM and regulatory operations. Highly regarded industry thought leader. Ability to deliver expertise in the following areas either as an individual or multi-level vetted teams for scale: Process Improvement & Optimization Regulatory Information Management Standards Definition Regulatory Data Governance ​Industry Benchmarking ​User Requirements ​Vendor Selection Assistance ​Education and Training ​Electronic Submissions (eCTD, RPS, etc.) Submission Authoring Regulatory Data Governance CTD/eCTD Authoring Templates and Style Guide.