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Post by ltta on Aug 1, 2019 10:11:26 GMT -5
7/31/2019 Clinical Research Specialist Westlake Village, CA Description Through the application of scientific and clinical training and expertise, the Clinical Research Scientist (CRS) is an integral member of the clinical development team for strategic and operational planning for Phase 1 through 3 development plans and clinical study protocols. The CRS may also work closely with pharmaceutical research on Early Phase I Clinical Pharmacology projects and Medical Affairs on scientific disclosures, presentations and thought leader interactions. Specific activities may include developing or contributing to the clinical/medical plan, the development, conduct and reporting of clinical trials; the implementation of clinical trials in partnership with Clinical Research Organizations (CRO); writing and review of study reports; publications and data dissemination; NDA/BLA submissions and contacts with regulatory agencies. The Clinical Research Scientist serves as a scientific resource and must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), and Good Clinical Practices (GCPs).
more....
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Post by ltta on Aug 6, 2019 11:16:26 GMT -5
8/5/2019 Executive Director, Regulatory Affairs & Safety Westlake Village CA
Description The Executive Director, Regulatory Affairs and Safety will be responsible for developing and leading regulatory strategies and activities for the organization, including clinical and commercial regulatory submissions on a global basis. This includes ensuring that all corporate regulatory goals are clearly defined, met and are in compliance with all current industry standards globally. This role will provide significant input on regulatory affairs processes, procedures, and tools to facilitate effective execution by the regulatory function across the organization. This individual must be highly skilled and provide expertise in both clinical and nonclinical regulatory strategy. In addition, this position also serves as the Global Safety Officer with responsibility for managing and overseeing MannKind’s drug safety and pharmacovigilance process. This includes managing compliance with standard operating procedures; regulatory safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA) and EMEA; and global, regional and country regulations for the reporting of adverse events to regulatory agencies. This role will have oversight of an internal Regulatory & Safety team, be a key member of the R&D leadership team, and requires a candidate with a deep knowledge and understanding of the global regulatory environment and a passion for patient care. Responsibilities Regulatory Affairs: Lead strategic and tactical aspects and assure implementation of pre-clinical, clinical, CMC, regulatory efforts for projects in all stages of development (pre-IND through NDA)
Anticipate global regulatory changes and develops proactive strategies accordingly.
Provide strategic guidance to drug development on all aspects of regulatory requirements, bringing products to the clinic, through regulatory approval, and to commercialization.
Responsible for commercial/medical regulatory activities including interactions with appropriate regulatory bodies (e.g. OPDP) that relate to commercialization and promotion.
Member of team that defines strategies for, coordinate the execution of, and ensure the proper archival of regulatory submissions including clinical trial applications; Investigational New Drug (IND) applications, New Drug Applications (NDA), and Marketing Authorization Approvals (MAAs)
Interpret FDA (and other regulatory body) communications, expectations and decisions to internal and external stakeholders (including CRO's, CMO's, consultants and contractors), developing and implementing successful issue resolution strategies.
Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities, including meeting requests, briefing packages, and fast track applications.
Counsel and advise senior management / CMO on status of global regulatory affairs strategies and tactics, procedures and practices and provides critical risk assessments of the strategic alternatives for regulatory filings.
Communicate with regulatory agencies regarding submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review
Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
Provide review and approval of all external facing communications advertising and promotional labeling to ensure compliance with corporate policy, US and international laws and regulations
Develop and plan innovative regulatory strategies for label enhancements and life cycle product management.
Assess project plans and timelines and ensures all projects are appropriately prioritized and key goals are met on time.
Oversee the regulatory collaboration with CROs or other partnering organizations and coordinate international submissions to meet regulatory requirements
Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures
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Post by ltta on Oct 8, 2019 11:26:51 GMT -5
Posted October 7, 2019
Associate Director, National Accounts (Market Access)
Position Summary
MannKind Corporation has an opening for an Associate Director, National Accounts (Market Access). This position will be responsible for directing the sales efforts/activities of assigned national managed care organization(s). Interact with Federal government agencies, institutions, group purchasing organizations and wholesalers on a national level, including but not limited to pharmacy associations and medical associations. Call on managed care organizations developing national strategies; provide technical and administrative product information and/or demonstrate and respond to requests for proposals. Develop and manage national accounts including the development of the overall value proposition, including positioning and product specifications. May also be involved in design and implementation of trade and government product reimbursement programs and policies. Responsible for new account development and/or growth of existing accounts. This is a field based position to be based near a major airport.
Principal responsibilities:
Develop, manage and maintain relationships with key stakeholders, including PBM's, Managed Care Organizations, Government Sponsored Health Plans, GPOs, Physician Networks, Trade Organizations and Integrated Delivery Networks.
Closely work in a collaborative environment across all groups which include Sales & Marketing, Managed Care Marketing, and Regulatory, Reimbursement, HUB Services, Finance and manufacturing. Identify opportunities to enhance sales of products, support marketing initiatives, and generally support MannKind products.....
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Post by mike0475 on Oct 10, 2019 14:31:25 GMT -5
Does anyone know if A is being prescribed in NC today?
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Post by cretin11 on Oct 10, 2019 15:31:23 GMT -5
I think I've seen posts on this board in the past that indicated the answer is Yes, but i'm not certain.
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Post by mike0475 on Oct 10, 2019 15:51:43 GMT -5
There’s a tweet with pic of new hires and one is Greensboro NC
Also look close at map of US in the pic. Darker shaded areas appear to have various points coast to coast
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Post by nylefty on Oct 10, 2019 16:01:05 GMT -5
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Post by porkini on Oct 10, 2019 16:14:47 GMT -5
Also, don't forget the UTHR facilities in Research Triangle Park, North Carolina.  |
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Post by peppy on Oct 10, 2019 16:20:27 GMT -5
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Post by mytakeonit on Oct 10, 2019 20:07:31 GMT -5
I clicked on how-to-get-afrezza in California ... zip 91403 (50 miles radius) where VDEX is ... and no William McCollough is listed.  Oh Oh ... But, that's mytakeonit |
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Post by cretin11 on Oct 11, 2019 3:37:39 GMT -5
I clicked on how-to-get-afrezza in California ... zip 91403 (50 miles radius) where VDEX is ... and no William McCollough is listed. Oh Oh ... And I just looked up the state of New Mexico and only two doctors are listed in the whole state, neither of which appear to be VDEX which we know is in NM (Espanola but moving to Santa Fe i think?). Whoever is in charge of that web site appears to be slacking. |
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Post by nylefty on Oct 11, 2019 9:49:31 GMT -5
I clicked on how-to-get-afrezza in California ... zip 91403 (50 miles radius) where VDEX is ... and no William McCollough is listed. Oh Oh ... But, that's mytakeonit You meant that as a joke, right? McCullough isn't a doctor and therefore wouldn't be listed. |
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Post by Clement on Oct 11, 2019 11:43:39 GMT -5
Does anyone know if A is being prescribed in NC today? In early spring of this year I tried to talk to my PCP (in Chapel Hill) about Afrezza. She said, " At UNC Healthcare, we don't prescribe that." I am not diabetic and I like her so I did not change doctors. |
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Post by mytakeonit on Oct 11, 2019 12:04:40 GMT -5
nylefty - that listing covers almost everyone from the nurse practitioner, endos, doctors ... maybe even janitors. Clement - change doctors. Don't let your personal feelings cause you to lose limbs or your life. But, that's mytakeonit |
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Post by nylefty on Oct 11, 2019 12:12:03 GMT -5
nylefty - that listing covers almost everyone from the nurse practitioner, endos, doctors ... maybe even janitors. Clement - change doctors. Don't let your personal feelings cause you to lose limbs or your life. But, that's mytakeonit It covers medical providers who can write prescriptions. McCullough and janitors can't do that. |
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Oh Oh ...