Hi Network! I am currently partnered with an Ophthalmology focused CRO looking to bring on a CTA to join their seasoned clinical team! Check out the details below. - Must be based in the greater Nashville, TN area. (onsite role) - 2+ years of Clinical Research experience within pharma industry - eTMF experience required! Interested? Send an updated copy of your CV to [email protected]! #CTA #clinicaloperations
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https://lnkd.in/gAR_QsJy Throughout my career with the FDA, I interviewed countless doctors in investigations of complaints and reports of device malfunctions from surgery to promotion by some salesmen. It is true, doctors that prescribe drugs and medical devices, even medical directors in clinical studies seem to have a misunderstanding and misconception of how FDA does it it supposed to do. The misunderstanding is only match by the patients that receive these products regulated by the agency. They especially have a misconception of how much the agency does of it mandate. Every thing from if it comes into the country it must have been checked by the agency to if it’s approved it must have checked by the agency. There is an incredible misunderstanding of how recalls work to the point of if it’s recall there must be none remaining on the market that they would use by mistake. Not a clue at times regardless of how incredibly it sounds. As we we very know most doctors don’t check anything that is handed to them, it’s risk assessment departments and company that receive notices of recalls etc. The communication between hospital and clinic systems is at times slow and ineffective. So the approval process is just an extension of this mess. Risk to the patient from start to use.
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***NOW HIRING*** I'm looking for a Senior Medical Affairs Director who has extensive experience in the CNS/Neuro space. This is a key Medical Affairs hire for a growing biopharma that recently received FDA approval. This person must live on the East Coast. The ideal candidate will have: - PharmD, PhD, or MD degree - 6+ years of relevant experience - Previous industry experience in CNS/Neurology - Exceptional communication skills - Launch experience Interested? Send me a quick message on LinkedIn or email your resume to [email protected] for more details!
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#hiring *Sr. MSL II, Glaucoma and Retina (IA, NE, KS, MO, AR, OK, CO)*, Omaha, *United States*, fulltime #jobs #jobseekers #careers #Omahajobs #Nebraskajobs #HealthcareMedical *Apply*: https://lnkd.in/gfMi8mY5 Job Description What Your New Manager Wants You To KnowThe territory for this position includes the following state s: IA, NE, KS, MO, AR, OK, CO. The candidate should live in one of the following areas: Oklahoma City, Kansas City or Colorado Springs. The Medical Science Liaison develops and maintains professional relationships with internal and external customers to provide comprehensive medical and scientific support to AbbVie initiatives in assigned therapeutic areas. Facilitates information, education, and research activities for physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized by AbbVie. Works closely with other AbbVie personnel to ensure information, education, and research needs of healthcare professionals are met and to ensure scientific and technical training needs of commercial organizations are identified and met Responsible for maintaining annual expenses within assigned budget parametersResponsible for accurate and timely documentation of above activitiesThe employee must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.This is a field-based role. Candidates can live anywhere within the territory of responsibility.YOU ARE more than just a title, YOU ARE A first class team playerYou WillIdentify, develop, and maintain professional relationships with thought leaders, academic centers and researchers in assigned areas of therapeutic interest to ensure access to current medical and scientific information on AbbVie products. Upon request, present data on AbbVie products to healthcare professionals including physicians, academic institutions, researchers, and other health care professionals. Support research initiatives as requested by AbbVie R&D, Clinical Operations, and Medical Affairs Departments. Serve as internal medical and scientific resource to assigned AbbVie therapeutic areas for development of disease-state and product communications and materials that are medically accurate, balanced, and consistent with regulatory guidelines. Support Round Table and Advisory Board sessions to ensure accuracy of scientific and clinical data. Conducts on-going training to medical affairs, field sales and other internal personnel as directed. May provide support for payer-facing activities to public and commercial managed markets.Significant Work Activities -Driving a personal auto or company car or truck, or a po
https://www.jobsrmine.com/us/nebraska/omaha/sr.-msl-ii-glaucoma-and-retina-ia-ne-ks-mo-ar-ok-co/469242926
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#hiring *Sr. MSL II, Glaucoma and Retina (IA, NE, KS, MO, AR, OK, CO)*, Omaha, *United States*, fulltime #jobs #jobseekers #careers #Omahajobs #Nebraskajobs #HealthcareMedical *Apply*: https://lnkd.in/gfMi8mY5 Job Description What Your New Manager Wants You To KnowThe territory for this position includes the following state s: IA, NE, KS, MO, AR, OK, CO. The candidate should live in one of the following areas: Oklahoma City, Kansas City or Colorado Springs. The Medical Science Liaison develops and maintains professional relationships with internal and external customers to provide comprehensive medical and scientific support to AbbVie initiatives in assigned therapeutic areas. Facilitates information, education, and research activities for physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized by AbbVie. Works closely with other AbbVie personnel to ensure information, education, and research needs of healthcare professionals are met and to ensure scientific and technical training needs of commercial organizations are identified and met Responsible for maintaining annual expenses within assigned budget parametersResponsible for accurate and timely documentation of above activitiesThe employee must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.This is a field-based role. Candidates can live anywhere within the territory of responsibility.YOU ARE more than just a title, YOU ARE A first class team playerYou WillIdentify, develop, and maintain professional relationships with thought leaders, academic centers and researchers in assigned areas of therapeutic interest to ensure access to current medical and scientific information on AbbVie products. Upon request, present data on AbbVie products to healthcare professionals including physicians, academic institutions, researchers, and other health care professionals. Support research initiatives as requested by AbbVie R&D, Clinical Operations, and Medical Affairs Departments. Serve as internal medical and scientific resource to assigned AbbVie therapeutic areas for development of disease-state and product communications and materials that are medically accurate, balanced, and consistent with regulatory guidelines. Support Round Table and Advisory Board sessions to ensure accuracy of scientific and clinical data. Conducts on-going training to medical affairs, field sales and other internal personnel as directed. May provide support for payer-facing activities to public and commercial managed markets.Significant Work Activities -Driving a personal auto or company car or truck, or a po
https://www.jobsrmine.com/us/nebraska/omaha/sr.-msl-ii-glaucoma-and-retina-ia-ne-ks-mo-ar-ok-co/469242926
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#hiring *MSL Field Director, Immunology - Rheumatology (Northeast)*, Charlotte, *United States*, fulltime #jobs #jobseekers #careers #Charlottejobs #NorthCarolinajobs #ExecutivePositions *Apply*: https://lnkd.in/gYFyz_VA Job Description Purpose: The Field Director, MSL (FD) plans, directs, coordinates and supports the activities of the Medical Science Liaisons (MSLs) within a designated geographic region to achieve scientific and business objectives within a therapeutic area of U.S. Medical Affairs. This includes, but is not limited to, coaching and mentoring for a designated number of medical level professionals (MSLs) in a therapeutic region. The FD reports to a therapeutic Field Medical Lead and works cross-functionally within U.S. Medical Affairs to identify, develop, implement, and monitor MSL strategies and tactics. Duties include strategic planning, financial management, personnel management, performance management process, regional awareness and expertise, data analysis, generation of metrics, material management, professional development, training, support, and execution of organizational goals and objectives. Responsibilities: People Leadership and Development: Recruitment and retention of key talent for AbbVie. Builds an organization reflecting a diverse and inclusive workforce through identification of team capability gaps and independent strengths. Establishes a productive work environment by creating trust and respect within the group and establishes self as a business partner. Consistently model "One-AbbVie" and AbbVie Ways of Working Leadership behaviors. People Leadership and Development: Provide coaching, mentoring and guidance that is consistent and timely to MSLs regarding their individual performance and progress, including annual performance reviews, growth and succession planning, and real time field reports based upon regular field travel combined with data analysis. Addresses performance issues decisively and appropriately in accordance with AbbVie's guidelines and Performance Excellence process. People Leadership and Development: Ultimate responsibility for scientific knowledge of self/team and oversight of MSL territory plans. Maintains clinical knowledge of designated therapeutic area and broad market knowledge of the region, including current treatment strategies, current and pending competitors, new therapeutic developments, payor dynamics, and other market issues/trends as it pertains to specific medical business interests. Regional Execution of Field-Medical Strategy: Maintain deep understanding of therapeutic strategy and interpretation of analytics to inform and maximize MSL Core Capabilities. Accountable for the direction and execution of MSL's regional goals/objectives and territory plans. Evaluate appropriate tools and analytics to ensure optimal trial performance through investigator engagement and excellen
https://www.jobsrmine.com/us/north-carolina/charlotte/msl-field-director-immunology-rheumatology-northeast/469045843
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#hiring Senior Director, Medical Affairs, San Jose, United States, fulltime #jobs #jobseekers #careers #SanJosejobs #Californiajobs #ExecutivePositions Apply: https://lnkd.in/dw3rBcaB ABOUT THE TEAM The external partnerships team within Visby Medical has had a pivotal role in the evolution of this technology: it has succeeded in obtaining 80 million dollars in non-dilutive funding from federal grants and contracts, appointed the company's scientific advisory board, represented Visby Medical at various federal agencies including the CDC, BARDA, NIH and the DoD, participated in negotiations with the pharmaceutical industry and initiated research projects with academic partners to evaluate the performance features of the Visby device and quantify its cost effectiveness. ABOUT THE JOB Visby Medical now seeks a Ph.D. scientist or M.D. physician scientist who will lead the external partnerships team as it seeks to accomplish the following objectives; HOW YOU'LL MAKE AN IMPACT Successfully compete for relevant grants and contracts from US Federal agencies including NIH, DoD, BARDA, CDC, from NGOs including the Bill and Melinda Gates Foundation and the Wellcome Trust and from public-private partnerships including CarbX. The resulting funds would be used to augment Visby Medical's R&D budget, fund high yield-high risk innovation projects, expand Visby Medical's product pipeline and support the use of the Visby device in settings where rapid molecular diagnostics are not currently available, including underserved populations. Initiate collaborations with the pharmaceutical industry to support deployment of the Visby platform as a companion/complementary diagnostic for emerging new antivirals or to expedite clinical trials of new antimicrobials. Initiate research partnerships with academic partners to carry out studies of the performance features and medical economics of the visby platform. Provide leadership to a talented team of external partnership scientists within Visby Medical. Be the Visby scientific and technical representative to agencies of the federal government. Participate in meetings of the technical, clinical trial and commercial teams within Visby, seeking synergies between the activities of the external partnership group and the missions of other groups within Visby. ON YOUR FIRST DAY WE'D LIKE YOU TO HAVE MD or PhD degree with a focus in infectious diseases; experience conducting multidisciplinary research projects; experience writing and managing research projects funded by external agencies, including agencies of the US federal government. Experience publishing the results of these projects in peer-reviewed journals. Experience presenting research findings to scientific and medical audiences. Prior work in or with USG agencies, foundations or public private partnerships in the areas of grants management, advocacy, policy development etc. Experience working i
https://www.jobsrmine.com/us/california/san-jose/senior-director-medical-affairs/444075975
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#hiring Senior Director, Medical Affairs, San Jose, United States, fulltime #jobs #jobseekers #careers #SanJosejobs #Californiajobs #ExecutivePositions Apply: https://lnkd.in/dw3rBcaB ABOUT THE TEAM The external partnerships team within Visby Medical has had a pivotal role in the evolution of this technology: it has succeeded in obtaining 80 million dollars in non-dilutive funding from federal grants and contracts, appointed the company's scientific advisory board, represented Visby Medical at various federal agencies including the CDC, BARDA, NIH and the DoD, participated in negotiations with the pharmaceutical industry and initiated research projects with academic partners to evaluate the performance features of the Visby device and quantify its cost effectiveness. ABOUT THE JOB Visby Medical now seeks a Ph.D. scientist or M.D. physician scientist who will lead the external partnerships team as it seeks to accomplish the following objectives; HOW YOU'LL MAKE AN IMPACT Successfully compete for relevant grants and contracts from US Federal agencies including NIH, DoD, BARDA, CDC, from NGOs including the Bill and Melinda Gates Foundation and the Wellcome Trust and from public-private partnerships including CarbX. The resulting funds would be used to augment Visby Medical's R&D budget, fund high yield-high risk innovation projects, expand Visby Medical's product pipeline and support the use of the Visby device in settings where rapid molecular diagnostics are not currently available, including underserved populations. Initiate collaborations with the pharmaceutical industry to support deployment of the Visby platform as a companion/complementary diagnostic for emerging new antivirals or to expedite clinical trials of new antimicrobials. Initiate research partnerships with academic partners to carry out studies of the performance features and medical economics of the visby platform. Provide leadership to a talented team of external partnership scientists within Visby Medical. Be the Visby scientific and technical representative to agencies of the federal government. Participate in meetings of the technical, clinical trial and commercial teams within Visby, seeking synergies between the activities of the external partnership group and the missions of other groups within Visby. ON YOUR FIRST DAY WE'D LIKE YOU TO HAVE MD or PhD degree with a focus in infectious diseases; experience conducting multidisciplinary research projects; experience writing and managing research projects funded by external agencies, including agencies of the US federal government. Experience publishing the results of these projects in peer-reviewed journals. Experience presenting research findings to scientific and medical audiences. Prior work in or with USG agencies, foundations or public private partnerships in the areas of grants management, advocacy, policy development etc. Experience working i
https://www.jobsrmine.com/us/california/san-jose/senior-director-medical-affairs/444075975
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#hiring *MSL Field Director, Immunology - Rheumatology (Northeast)*, Philadelphia, *United States*, fulltime #jobs #jobseekers #careers #Philadelphiajobs #Pennsylvaniajobs #ExecutivePositions *Apply*: https://lnkd.in/grFYaSsG Job Description Purpose: The Field Director, MSL (FD) plans, directs, coordinates and supports the activities of the Medical Science Liaisons (MSLs) within a designated geographic region to achieve scientific and business objectives within a therapeutic area of U.S. Medical Affairs. This includes, but is not limited to, coaching and mentoring for a designated number of medical level professionals (MSLs) in a therapeutic region. The FD reports to a therapeutic Field Medical Lead and works cross-functionally within U.S. Medical Affairs to identify, develop, implement, and monitor MSL strategies and tactics. Duties include strategic planning, financial management, personnel management, performance management process, regional awareness and expertise, data analysis, generation of metrics, material management, professional development, training, support, and execution of organizational goals and objectives. Responsibilities: People Leadership and Development: Recruitment and retention of key talent for AbbVie. Builds an organization reflecting a diverse and inclusive workforce through identification of team capability gaps and independent strengths. Establishes a productive work environment by creating trust and respect within the group and establishes self as a business partner. Consistently model "One-AbbVie" and AbbVie Ways of Working Leadership behaviors. People Leadership and Development: Provide coaching, mentoring and guidance that is consistent and timely to MSLs regarding their individual performance and progress, including annual performance reviews, growth and succession planning, and real time field reports based upon regular field travel combined with data analysis. Addresses performance issues decisively and appropriately in accordance with AbbVie's guidelines and Performance Excellence process. People Leadership and Development: Ultimate responsibility for scientific knowledge of self/team and oversight of MSL territory plans. Maintains clinical knowledge of designated therapeutic area and broad market knowledge of the region, including current treatment strategies, current and pending competitors, new therapeutic developments, payor dynamics, and other market issues/trends as it pertains to specific medical business interests. Regional Execution of Field-Medical Strategy: Maintain deep understanding of therapeutic strategy and interpretation of analytics to inform and maximize MSL Core Capabilities. Accountable for the direction and execution of MSL's regional goals/objectives and territory plans. Evaluate appropriate tools and analytics to ensure optimal trial performance through investigator engagement and ex
https://www.jobsrmine.com/us/pennsylvania/philadelphia/msl-field-director-immunology-rheumatology-northeast/469045842
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