MakroCare is an Expert Strategic Development andCommercialization Global Partner for Pharmaceutical, Biotechnology and MedicalDevice industries. Our Experience, Programs and Processes bring a New Dimensionto Development Strategy, Regulatory/Risk Planning & Management, ClinicalResearch, Medical/Scientific Support and Emerging Region Expansion
Medical Advisor(Medical Affairs department)
Responsibilities:
• Advise onclinical and medical area inputs in designingclinical trials for drugs (both new and post-approval) and devices
• Review clinical study documents (like protocols, studysynopsis, labeling) for scientific accuracy and suggest improvements
• Undertake protocol and product briefing and interactwith other departments medical writing, clinical data, biostatistics, medicaldevice, scientific, CDM, BioStats.
• Support in effort estimation for Safety Queries,preparation of CSR, articles for publications and other materials as and whenrequired
• Perform detailed literature search (focusing onpharmacology, patient groups, safety, labeling, etc) utilizing both public andprivate databases and show apt while synthesizing the results needed forclinical designs to cover safety, performance, efficacy and effectiveness ofdrugs/devices
• Coordinate with medical writers (and othercross-functional teams) in the data review, analysis and reporting of studies.
• Be responsible, in conjunction with other teams, foroverall content and accuracy of study report before forwarding for finalsign-off. Assist with internal and external dissemination of results toDevelopment Team, Investigators etc.
• Provide mentoring, and training for other team members
• Work with multinational project teams and coordinateactivities on multiple projects
• Function independently with initiative and minimalguidance
• Have attention to detail and focus on quality
• Have excellent English writing skills, strong verbaland written communication skills
• Work effectively in a team setting, take overadditional responsibilities
• Contribute to cross-functional working groups asneeded.
• Travel as needed to client locations or conferences
• Other Responsibilities as assigned by company relatedto medical and clinical areas
MakroCare | AMakroGroup Company | www.MakroCare.com
MakroCare is an Expert Strategic Development andCommercialization Global Partner for Pharmaceutical, Biotechnology and MedicalDevice industries. Our Experience, Programs and Processes bring a New Dimensionto Development Strategy, Regulatory/Risk Planning & Management, ClinicalResearch, Medical/Scientific Support and Emerging Region Expansion.
MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS),ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)
MakroCare Awardedas:
• BestBiopharmaceutical Regulatory Consultancy Firm – Global Health & Pharma
• BestPharmaceutical Strategic Development Specialist - UK Enterprises
• TheOutstanding Consulting Firm - Insights Success
• AIExcellence in Regulatory & Automation Solutions - Acquisition International
• AIExcellence in Best Bio Pharma Development Partner - Acquisition International
• Best Practices Award - ClinicalInformatics
• NJExcellence Award - US Institute for Excellence in Commerce
• BestBiotech Award - US Commerce Association
• Clinical Research Team and Best Technological Development in ClinicalTrials Finalists - Scrip Awards
• Circle Of Excellence – MerchantCircle
About MakroGroup |www.MakroGrp.com
Makro Group of Organizations established in 1996, Makroprovides a complete range of solutions for every stage of business andinformation lifecycle.
• MakroCare, DDi, MakroTech and MakroScientific are MakroGroup Companies
• DDiAwarded by Insights Success, CIO, Corporate LiveWire, Pharma Tech Outlook,Clinical Informatics & SCRIP
• MakroTech is Awarded 3-time FAST 500(Deloitte), 3-time INC 5000 company & TOP 100 diversity business in NJ
• MakroFoundation is a Suicide Prevention Helpdesk, part of Makro CSRInitiative, has counseled over 3000 people.