My Medical Department

My Medical Department

Pharmaceutical Manufacturing

A physician-led team committed to upholding patient safety, providing a full array of medical team functions

About us

My Medical Department is a physician-led global medical consultancy, bringing excellence to the development and use of your products throughout their lifecycle. Our versatile team offers a range of solutions, tailored to your organisation’s specific needs. We are a specialized pharmaceutical medicine consultancy, providing a full array of medical team functions throughout the product life cycle. Our innovative service provides the operations of a full medical department, only charging for what you actually use. As a physician-led team committed to upholding patient safety, we place a strong focus on the quality of our work and integrity of decision-making. Please talk to us about how we may help you.

Industry
Pharmaceutical Manufacturing
Company size
11-50 employees
Headquarters
Australia & United Kingdom
Type
Privately Held
Founded
2014
Specialties
Strategy Consultancy: Competitive landscape analysis to inform strategic decisions Portfolio management: in- and out-licensing; R&D stop-go decisions Target product profiles & Clinical Development Plans., Medical Affairs: Promotional claims optimisation, substantiation & defense Compliance reviews and medical sign-off Engagement with KOLs & other external stakeholders Advisory Board planning, implementation and write-up Medical Information functions Field force training Medical writing., Market Access: Medical elements of pricing & reimbursement strategy and Health Technology Appraisals Advanced budgetary notification Formulary access materials; formulary submissions & defence meetings., Clinical Trials phase I - IV: Trial design optimisation to support promotional claims, pricing & reimbursement Medical Monitor / Clinical Research Physician / Clinical Research Scientist Medical statistics & data oversight including SAE reconciliation Medical Writing from protocol to CSR Clinical Operations including CRA, site monitoring, co-monitoring and recruitment optimisation activities Forensic data management and bringing trials back “in-house”., Pharmacovigilance: Medical review of safety information (ICSR’s & literature): narrative writing; assessment of coding, causality and expectedness Safety reporting: interim and cumulative reports; investigation of putative safety signals Risk-benefit analysis to inform product label changes Safety database and QPPV by arrangement., and Other Services: We can provide and manage a range of other services via existing collaboration agreements with our network of experts including: Compliance & Audit; Regulatory Affairs; Biostatistics; Health Economics.

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