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PhRMA Careers, Director – Scientific & Regulatory Affairs

PhRMA  |  PhRMA Career

PhRMA is devoted to advancing public policies in the U.S. and around the world that support innovative medical research, yield progress for patients today and provide hope for the treatments and cures of tomorrow.
https://www.phrma.org/careers/phrma-careers-director-scientific-and-regulatory-affairs

PhRMA Statement on Rx Response’s Pharmacy Status Reporting Tool Activation in 11 States and the District of Columbia

PhRMA  |  Press Release

Find  PhRMA Online: Website – http://www.phrma.org facebook – www.facebook.com/PhRMA Blog – www.phrma.org/catalyst Twitter – www.Twitter.com/PhRMA and www.Twitter.com/PhRMApress YouTube – www.youtube.com/PhRMApress For information on how innovative medicines save lives, visit: http://www.innovation.orgFor information on the Partnership for Prescription Assistance, visit: http://www.pparx.orgFor information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org
https://www.phrma.org/press-release/phrma-statement-on-rx-response-s-pharmacy-status-reporting-tool-activation-in-11-states-and-the-district-of-columbia

Improving FDA’s combination product review process could increase epinephrine auto-injector competition

PhRMA  |  Blog Post

Combination products that consist of a medicine and delivery device are important treatment options for patients and have the potential to improve public health.
http://catalyst.phrma.org/improving-fdas-combination-product-review-process-could-increase-epinephrine-auto-injector-competition

New report provides recommendations for securing and protecting IP

PhRMA  |  Blog Post

Intellectual Property Enforcement Coordinator (IPEC) issued a Joint Strategic Plan outlining actions government, industry, educational institutions and consumer protection and public interest groups can take over the next three years to promote and protect the ideas, brands and inventions that drive America’s dynamic innovation economy, support more than 45 million jobs across the country and account for more than half of all U.S. exports.
http://catalyst.phrma.org/new-report-provides-recommendations-for-securing-and-protecting-ip

ICYMI: Physicians want better information sharing with biopharmaceutical companies

PhRMA  |  Blog Post

 In fact, this is an important element of our responsibility to patients and the public.
http://catalyst.phrma.org/icymi-physicians-want-better-information-sharing-with-biopharmaceutical-companies

PhRMA Statement on Foreign Clinical Trials

PhRMA  |  Press Release

PhRMA Internet Address: www.phrma.org For information on stories of hope and survival, visit: http://sharingmiracles.com/ PhRMA en Español: www.nuestraphrma.org For information on how innovative medicines save lives, visit: www.innovation.org For information on the Partnership for Prescription Assistance, visit: www.pparx.org For more information on public health emergencies, visit: www.rxresponse.org For information on the danger of imported drugs, visit: www.buysafedrugs.info
https://www.phrma.org/press-release/phrma-statement-on-foreign-clinical-trials

Director of Development – Healthcare Ready

PhRMA  |  PhRMA Career

Excellent interpersonal and written communication skills.
https://www.phrma.org/careers/director-of-development-healthcare-ready

Larry Hausner, MBA

PhRMA  |  Biography

Before joining the American Diabetes Association, Hausner served as Chief Operating Officer for The Leukemia & Lymphoma Society, where he had oversight and management of revenue generation, finance and budget, information technology, patient services, public policy, marketing and communications, human resources, and field management. 
https://www.phrma.org/biography/larry-hausner-mba

Pacira settlement important step towards ensuring clinicians have access to the best available data on FDA-approved medicines

PhRMA  |  Blog Post

But, as the legal landscape continues to shift, PhRMA stands ready to work with FDA and health care professionals to develop a clear regulatory framework that prioritizes the sharing of accurate, timely data to improve health outcomes for patients, and eliminates confusion surrounding the communication between biopharmaceutical companies and clinicians.
http://catalyst.phrma.org/pacira-settlement-important-step

PhRMA Statement on FDA Biomedical Innovation Report

PhRMA  |  Press Release

Find PhRMA Online: Website – http://www.phrma.org Facebook – www.facebook.com/PhRMA Blog – www.phrma.org/catalyst Twitter – www.Twitter.com/PhRMA and www.Twitter.com/PhRMApress YouTube – www.youtube.com/PhRMApress  For information on how innovative medicines save lives, visit: http://www.innovation.orgFor information on the Partnership for Prescription Assistance, visit: http://www.pparx.orgFor information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org
https://www.phrma.org/press-release/phrma-statement-on-fda-biomedical-innovation-report

Introducing clinical research participation to the everyday person

PhRMA  |  Blog Post

Danielle works on a variety of projects in this role, including managing communications for AWARE For All, writing for CISCRP's many public-facing platforms, and engaging both professionals and the public in meaningful conversations about clinical research.
http://catalyst.phrma.org/introducing-clinical-research-participation-to-the-everyday-person

Joint BIO/PhRMA Statement on PDUFA Reauthorization

PhRMA  |  Press Release

It made meaningful improvements to the human drug review program such as increased communication between FDA and biopharmaceutical companies during drug development and regulatory review to promote regulatory transparency and predictability.
https://www.phrma.org/press-release/joint-bio/phrma-statement-on-pdufa-reauthorization

Biopharmaceutical Companies Face Restrictions in Sharing Scientific Information to Improve Patient Care

PhRMA  |  Blog Post

  It is time for us to pivot in terms of how we think about biopharmaceutical company communications with healthcare professionals, including physicians.
http://catalyst.phrma.org/biopharmaceutical-companies-face-restrictions-in-sharing-scientific-information-to-improve-patient-care

PhRMA Statement on FDA Draft Guidance on Labeling for Products Approved Under the Accelerated Approval Pathway

PhRMA  |  Press Release

Find PhRMA Online: Website – http://www.phrma.org Facebook – www.facebook.com/PhRMA Blog – www.phrma.org/catalyst Twitter – www.Twitter.com/PhRMA and www.Twitter.com/PhRMApress YouTube – www.youtube.com/PhRMApress For information on how innovative medicines save lives, visit: http://www.innovation.org For information on the Partnership for Prescription Assistance, visit: http://www.pparx.org For information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org  
https://www.phrma.org/press-release/phrma-statement-on-fda-draft-guidance-on-labeling-for-products-approved-under-the-accelerated-approval-pathway

Senior Director of Infrastructure and Operations

PhRMA  |  PhRMA Career

The Senior Director of Infrastructure and Operations is responsible for: Planning and directing the design, deployment, and implementation of on premise and cloud technology infrastructure, including information security, network administration, device management, system architecture, telecommunications, and business continuity and disaster recovery; Developing and documenting best practices, standards, “as built” diagrams, network segmentation and configuration, and security operations; Responsible for providing a high-level of Tier 1, 2 and 3 customer support; Supporting a mixed client Windows and Mac environment; Managing multiple service providers and ensuring seamless coordination among them; Supervising and mentoring junior staff; Developing and managing service level agreements; Communicating to the organization network and systems downtime, changes, and new services; Being available after hours and on weekends to facilitate network and systems upgrades and maintenance as well as address emergency network problems.
https://www.phrma.org

PhRMA Principles on Conduct of Clinical Trials

PhRMA  |  Codes & Guidelines

Under those Principles, biopharmaceutical companies commit to enhance data sharing with qualified researchers, share results with the patients who participate in clinical trials, enhance public access to clinical study information, and reaffirm their commitment to publish clinical trial results. 
https://www.phrma.org/codes-and-guidelines/phrma-principles-on-conduct-of-clinical-trials

RxOpen Activated to Report on Status of Pharmacies in Oklahoma

PhRMA  |  Press Release

Find PhRMA Online: Website – http://www.phrma.org Facebook – www.facebook.com/PhRMA Blog – www.phrma.org/catalyst Twitter – www.Twitter.com/PhRMA and www.Twitter.com/PhRMApress YouTube – www.youtube.com/PhRMApress For information on how innovative medicines save lives, visit: http://www.innovation.org For information on the Partnership for Prescription Assistance, visit: http://www.pparx.org For information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org
https://www.phrma.org/press-release/rxopen-activated-to-report-on-status-of-pharmacies-in-oklahoma

Director – Federal Advocacy

PhRMA  |  PhRMA Career

Requirements Bachelor’s degree in Political Science, Government Relations or other related field of study;  5-7 years of combined legislative, White House, government affairs consulting and/or pharmaceutical industry experience; Understanding of procedures, protocols of standing committees regarding witnesses, testimony and Congressional activities, working knowledge of the Congressional process and ethics rules and regulations; Strong relationship building skills, integrity and reputation; Strong verbal and written communication skills; Demonstrated collaborator and team player.
https://www.phrma.org

ICYMI: Survey highlights key barriers limiting number and scale of new approaches to paying for medicines

PhRMA  |  Blog Post

Allow a full range of truthful and non-misleading communications between innovators and payers for all medically accepted uses of medicines.
http://catalyst.phrma.org/icymi-survey-highlights-key-barriers-limiting-number-and-scale-of-new-approaches-to-paying-for-medicines

ICYMI: Survey highlights key barriers limiting number and scale of new approaches to paying for medicines

PhRMA  |  Blog Post

Allow a full range of truthful and non-misleading communications between innovators and payers for all medically accepted uses of medicines.
http://catalyst.phrma.org/icymi-survey-highlights-key-barriers-limiting-number-and-scale-of-new-approaches-to-paying-for-medicines

Celebrating Anniversaries: Americans with Disabilities Act

PhRMA  |  Blog Post

Here is just a small section – the findings: The Congress finds that (1) physical or mental disabilities in no way diminish a person's right to fully participate in all aspects of society, yet many people with physical or mental disabilities have been precluded from doing so because of discrimination; others who have a record of a disability or are regarded as having a disability also have been subjected to discrimination; (2) historically, society has tended to isolate and segregate individuals with disabilities, and, despite some improvements, such forms of discrimination against individuals with disabilities continue to be a serious and pervasive social problem; (3) discrimination against individuals with disabilities persists in such critical areas as employment, housing, public accommodations, education, transportation, communication, recreation, institutionalization, health services, voting, and access to public services; (4) unlike individuals who have experienced discrimination on the basis of race, color, sex, national origin, religion, or age, individuals who have experienced discrimination on the basis of disability have often had no legal recourse to redress such discrimination; (5) individuals with disabilities continually encounter various forms of discrimination, including outright intentional exclusion, the discriminatory effects of architectural, transportation, and communication barriers, overprotective rules and policies, failure to make modifications to existing facilities and practices, exclusionary qualification standards and criteria, segregation, and relegation to lesser services, programs, activities, benefits, jobs, or other opportunities; (6) census data, national polls, and other studies have documented that people with disabilities, as a group, occupy an inferior status in our society, and are severely disadvantaged socially, vocationally, economically, and educationally; (7) the Nation's proper goals regarding individuals with disabilities are to assure equality of opportunity, full participation, independent living, and economic self-sufficiency for such individuals; and (8) the continuing existence of unfair and unnecessary discrimination and prejudice denies people with disabilities the opportunity to compete on an equal basis and to pursue those opportunities for which our free society is justifiably famous, and costs the United States billions of dollars in unnecessary expenses resulting from dependency and nonproductivity.
http://catalyst.phrma.org/celebrating-anniversaries-americans-with-disabilities-act

Responsible Clinical Trial Data Sharing Is Enhancing Science and Improving Patient Health

PhRMA  |  Blog Post

In addition to the company efforts, there are numerous public collaborations such as Project Data Sphere that not only aggregate data but bring together the best scientific minds to produce new analyses and tackle the most pressing questions in drug development.
http://catalyst.phrma.org/responsible-clinical-trial-data-sharing-is-enhancing-science-and-improving-patient-health

Over 900 Biotechnology Medicines in Development, Targeting More than 100 Diseases

PhRMA  |  Press Release

Find PhRMA Online: Website – http://www.phrma.org Facebook – www.facebook.com/PhRMA Blog – www.phrma.org/catalyst Twitter – www.Twitter.com/PhRMA and www.Twitter.com/PhRMApress YouTube – www.youtube.com/PhRMApress  For information on how innovative medicines save lives, visit: http://www.innovation.orgFor information on the Partnership for Prescription Assistance, visit: http://www.pparx.orgFor information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org
https://www.phrma.org/press-release/over-900-biotechnology-medicines-in-development-targeting-more-than-100-diseases

The Vital Role of Clinical Outcome Assessments in Patient-Centered Drug Development

PhRMA  |  Blog Post

While not intended to substitute for dialogue between innovators and FDA on specific drug development programs and plans, the proposed compendium will improve public visibility into the Agency’s opinion of available tools, specifically those that have been included in the labels of approved medicines or are in the process of qualification.
http://catalyst.phrma.org/the-vital-role-of-clinical-outcome-assessments-in-patient-centered-drug-development

PhRMA Joins with National Minority Quality Forum and Microsoft to Address Diversity in Clinical Trials

PhRMA  |  Press Release

Find PhRMA Online: Website – http://www.phrma.org Facebook – www.facebook.com/PhRMA Blog – www.phrma.org/catalyst Twitter – www.Twitter.com/PhRMA and www.Twitter.com/PhRMApress YouTube – www.youtube.com/PhRMApress For information on how innovative medicines save lives, visit: http://www.innovation.org For information on the Partnership for Prescription Assistance, visit: http://www.pparx.org For information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org   
https://www.phrma.org/press-release/phrma-joins-with-national-minority-quality-forum-and-microsoft-to-address-diversity-in-clinical-trials

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