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Austin Texas Jobs... The Job Beat
Job, Career and Business Resource Guide

You searched for Biotech Jobs in Austin, TX

Regulatory Affairs Consultant (MyBiotechCareer)
Austin, TX -- We are seeking a driven individual with a passion for the pharmaceutical industry. 1 of our clients is looking to add a strong Regulatory Affairs Consultant to their team. Assignments include: 1) Research and advise on device classification and regulatory pathways and strategies 2) Prepare and submit regulatory premarket submissions 3) Communicate specific qualifications for effective submissions 4) Assist in addressing and responding to deficiencies of product submissions 5) Review documentation and advise clients in developing more effective documentation 6) Prepare meeting requests between clients and the FDA 7) Interact and negotiate directly with regulatory authorities 8) Assist clients with other regulatory concerns 9) Comply with company’s policies and procedures 10) Perform other duties as assigned

Clinical Product Manager (MyBiotechCareer)
Austin, TX -- Our client, a leading pharmaceutical company, is currently seeking an accomplished Clinical Product Manager to join the team. Here is an overview of the role: 1) Lead and develop clinical programs 2) Provide medical input into product development strategies 3) Serve as a Medical Monitor for clinical trials, as required 4) Develop and maintain strong relationships with clinical investigators and experts 5) Lead and develop clinical study protocols 6) Review and interpret clinical data 7) Review clinical sections of regulatory documents 8) Identify new product opportunities 9) Comply with company’s operating guidelines 10) Perform other duties as assigned

Senior Program Manager (MyBiotechCareer)
Austin, TX -- A brilliant opportunity exists for an outstanding individual capable of fitting into this very rewarding Senior Program Manager role. Our client, a leading medical device company, is looking to hire someone who can bring added value to the team. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you. Assignments include: 1) Align program scope and strategic business objectives 2) Represent customer and market viewpoints to make technical and program decisions 3) Demonstrate program management best practices 4) Improve product development process effectiveness 5) Define, implement and bring to market new products, technologies and services 6) Lead the team in preparing Go and No-Go decisions 7) Lead program planning processes, ensuring qualifications are clear and driven by customer needs 8) Define and evaluate roles, responsibilities, goals and deliverables for the program and extended teammates

Vice President of Clinical Development (MyBiotechCareer)
Austin, TX -- Our client, a leading biopharmaceutical company, is currently recruiting a Vice President of Clinical Development who will infuse the Clinical Development Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Assignments include: 1) Design clinical trials and execute clinical and regulatory strategies 2) Establish and maintain a work atmosphere focused on quality products 3) Lead and build the Clinical Development Team to carry out clinical operations 4) Develop clinical and regulatory strategies 5) Develop product profiles and commercialization strategies 6) Ensure adherence to GCP/ICH standards and internal SOPs in conducting clinical trials 7) Prepare publications and presentations for external meetings 8) Manage and govern external vendors involved in designing clinical trials 9) Perform other duties as assigned

Senior Director of Financial Planning and Analysis (MyBiotechCareer)
Austin, TX -- Our client, a leading biotechnology company, is currently seeking an ambitious and gifted Senior Director of Financial Planning and Analysis to help lead their team. This is a unique opportunity for a highly motivated applicant with a go-getter attitude and a drive to succeed. Assignments include: 1) Present business, financial and operational performances and analysis 2) Enhance and deliver monthly reporting packages 3) Track, analyze and manage capital expenditures 4) Develop and execute processes and tools 5) Manage personnel growth and related costs 6) Coordinate the company’s financial processes and systems 7) Develop and analyze the annual budget and periodic reforecasts 8) Support long-range planning models 9) Lead longterm strategic plans 10) Identify and deliver value added analysis 11) Oversee cross-functional projects

Customer Engagement Manager (MyBiotechCareer)
Austin, TX -- We are seeking a driven individual with a passion for the medical device industry. 1 of our clients is looking to add a strong Customer Engagement Manager to their team. Assignments include: 1) Define distinct consumer segments 2) Discover, pursuit and execute customer follow up and communication 3) Develop and implement segmentation programs 4) Ensure data is integrated in such a way that campaigns are effective 5) Meet program milestones on time and adhere to deliverables 6) Develop and launch consumer webinar programs 7) Maximize follow up on local marketing programs 8) Partner with digital channel activation teams 9) Develop new methods and processes 10) Comply with company’s policies and procedures

Clinical Specialist II (CampusRN.com)
Austin, TX -- For more than 125 yrs, we've brought new products and technologies to the world - in nutrition, diagnostics, medical devices and branded generic...

Director of Regulatory Affairs and Labeling (MyBiotechCareer)
Austin, TX -- A leading pharmaceutical company is currently seeking a Director of Regulatory Affairs and Labeling to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Job duties include: 1) Set goals and expectations for staff with their inputs 2) Mentor, lead, coach and develop employees 3) Manage and address performance issues 4) Communicate site and departmental goals and expectations to staff 5) Provide performance reports with feedback 6) Comply with FDA guidance, policies and procedures 7) Identify and implement activities to support project and corporate goals 8) Manage and lead all activities and interactions with FDA and other regulatory authorities 9) Make key decisions regarding regulatory strategies 10) Perform other duties as assigned

Director of Clinical Operations (MyBiotechCareer)
Austin, TX -- A leading biotechnology company is currently seeking a Director of Clinical Operations to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Job duties include: 1) Establish and drive successful relationships with investigator sites and CROs 2) Direct, supervise and manage all aspects of global clinical trials execution 3) Oversee the Quality Management to study vendors 4) Comply with SOPs, FDA regulations and GCP guidelines 5) Build and lead an internal team 6) Oversee Clinical Operations’ components 7) Comply with company’s policies and procedures 8) Oversee and study budgets and contracts 9) Collaborate with company’s leadership and other cross-functional teammates 10) Perform other duties as assigned

Regulatory Affairs Director (MyBiotechCareer)
Austin, TX -- Our client, a leading pharmaceutical company, is currently recruiting a Regulatory Affairs Director who will infuse the Regulatory Affairs Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Assignments include: 1) Coordinate scientific, medical and regulatory competences 2) Define objectives, set strategies and implement action plans 3) Identify observational studies for longterm strategic plans 4) Write technical and scientific briefing notes 5) Monitor and develop clinical studies required for the registration of company's products 6) Identify stakeholders for regulatory and pharmacovigilance issues 7) Identify investigating centers within the territory 8) Comply wth company's policies and procedures 9) Perform other duties as assigned

Director of Clinical Research (MyBiotechCareer)
Austin, TX -- Our client, a leading life sciences company, is currently recruiting a Director of Clinical Research who will infuse the Clinical Research Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Assignments include: 1) Direct and implement clinical research plans and programs 2) Develop clinical protocols to meet company's objectives 3) Oversee clinical programs and review and monitor safety data 4) Identify, monitor and resolve clinical issues 5) Interpret study data and develop integrated summaries 6) Implement medical, scientific and clinical research techniques 7) Comply with company's policies and procedures 8) Coordinate with key opinion leaders regarding program strategies 9) Perform other duties as assigned

Vice President of Production (MyBiotechCareer)
Austin, TX -- Our client, a leading contract research organization, is currently recruiting a Vice President of Production who will infuse the Production Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Assignments include: 1) Oversee company's marketing and sales strategies 2) Create short and longterm plans and budgets 3) Achieve annual revenue and EBITDA targets 4) Oversee analytical and process development activities 5) Collaborate with internal functions and clients 6) Meet current and future business needs 7) Support ongoing organizational needs 8) Attend technical meetings 9) Support clients’ global regulatory submissions 10) Perform other duties as assigned

Product Development Manager (MyBiotechCareer)
Austin, TX -- A brilliant opportunity exists for an outstanding individual capable of fitting into this very rewarding Product Development Manager role. Our client, a leading veterinary pharmaceutical company, is looking to hire someone who can bring added value to the team. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you. Assignments include: 1) Oversee project-related proposals 2) Prepare, design and implement product development plans 3) Interact with regulatory agencies 4) Participate in cross-functional product development teams 5) Obtain regulatory approval in global markets 6) Lead global clinical development projects 7) Lead life-cycle management projects, as needed 8) Comply with FDA and other regulatory agencies 9) Perform other duties as assigned

Scientific Director (MyBiotechCareer)
Austin, TX -- Our client, a leading pharmaceutical company, is currently seeking an ambitious and gifted Scientific Director to help lead their team. This is a unique opportunity for a highly motivated applicant with a go-getter attitude and a drive to succeed. Assignments include: 1) Implement clinical epidemiology research programs and trials 2) Develop, manage and approve scientific methods 3) Design clinical protocols, case report forms, guidelines, study reports and manuscripts 4) Train internal and external project teammates 5) Lead clinical projects for medical and scientific trials 6) Develop and review consent documents 7) Review medical monitoring and safety plans 8) Update protocols, investigator brochures and product labels, as required 9) Interact with CROs, healthcare consultants and investigators 10) Oversee and participate in clinical study report writing 11) Support strategic and business objectives 12) Analyze and support new business ventures 13) Oversee business development presentations

Senior Vice President of Regulatory Affairs (MyBiotechCareer)
Austin, TX -- A leading company in the pharmaceutical industry is currently seeking a Senior Vice President of Regulatory Affairs to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Key duties include: 1) Interact with the FDA and other national health authorities 2) Ensure CAPAs are implemented and completed 3) Oversee quality control through internal assessments, audits, reviews and measurable metrics 4) Direct planning activities of operational budgets 5) Review expense processes and oversee budgets and constraints 6) Document and prioritize business qualifications 7) Develop, enhance and integrate new and existing programs 8) Oversee and monitor regulatory license and registration processes 9) Develop policies, programs and systems to support strategic direction of the department 10) Monitor new, modified and existing state and federal regulations

Director of Regulatory Affairs (MyBiotechCareer)
Austin, TX -- Our client, a leading biopharmaceutical company, is currently recruiting a Director of Regulatory Affairs who will infuse the Regulatory Affairs Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Assignments include: 1) Develop regulatory strategies and support for development programs, marketing applications and post-marketing activities 2) Assist with developing regulatory project timelines and managing IND/NDA and global regulatory submissions 3) Lead regulatory activities, including planning, drafting and reviewing CMC sections of regulatory submissions 4) Ensure compliance with FDA and international regulations and guidelines 5) Support IND and NDA applications 6) Keep abreast of changes in agency regulations and qualifications 7) Maintain well-organized and auditable regulatory files 8) Provide regulatory support for quality assurance and regulatory compliance activities

Vice President of Medical Affairs (MyBiotechCareer)
Austin, TX -- A pharmaceutical company is currently seeking a Vice President of Medical Affairs to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Key duties include: 1) Develop and maintain relationships with global KOL, clients and internal groups 2) Provide vision and leadership for the Oncology Medical Department 3) Assist with peers by providing scientific input at critical junctures 4) Maintain portfolio and enterprise strategic plans 5) Train internal groups on disease, treatment, new products and indications 6) Identify potential opportunities for existing products and new business efforts 7) Design client product portfolios 8) Maintain agency standards by supervising the Medical Department 9) Perform other duties as assigned

Patient Representative (CampusRN.com)
Austin, TX -- It helps us to better evaluate your requirements and will be used to determine salary if you are selected for this position....

Executive Director of Clinical Research (MyBiotechCareer)
Austin, TX -- A leading life sciences company is currently seeking an Executive Director of Clinical Research to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Position assignments include: 1) Design and provide insight of clinical research plans and programs 2) Participate in recruitment, selection, performance and succession of planning activities 3) Oversee and resolve operational aspects of clinical studies 4) Review and monitor safety data of clinical programs 5) Identify trends and signals 6) Identify, monitor and resolve clinical programs and trial issues 7) Interpret and study data and develop integrated summaries of safety and efficacy 8) Provide scientific leadership for regulatory documents' creation 9) Integrate and implement new resources and techniques with existing ones 10) Perform other duties as assigned

Director of Medical Affairs (MyBiotechCareer)
Austin, TX -- A leading pharmaceutical company is currently seeking a Director of Medical Affairs to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Position assignments include: 1) Identify strategic medical engagements with national opinion leaders 2) Comply with quality, grants, studies and costs center 3) Plan, coordinate and maintain continuous improvement of content, processes and methods 4) Provide accurate, efficient clinical and technical info for multisource products 5) Develop and implement medical affairs trainings and programs 6) Develop new claims for key brand products 7) Oversee external vendors and consultants 8) Lead and review scientific materials for data dissemination 9) Ensure time-bound data dissemination and field-based activities for marketed products 10) Perform other duties as assigned

Quality Head (MyBiotechCareer)
Austin, TX -- We are seeking a driven individual with a passion for the pharmaceutical industry. 1 of our clients is looking to add a strong Quality Head to their team. Assignments include: 1) Evaluate, track and monitor the quality control activities 2) Evaluate complete formulation records and other relevant details 3) Review sampling instructions, specifications, test methods, quality control procedures and SOPs 4) Ensure that required training of personnel is carried out 5) Approve and monitor analyses carried out under contract 6) Investigate reprocessing and rework of products, complaints and returns 7) Identify trends in the industry and recommend improvements 8) Participate in activities associated with FDA 9) Ensure that appropriate validations are carried out 10) Perform other duties as assigned

Associate Director of Product Marketing (MyBiotechCareer)
Austin, TX -- We are seeking a driven individual with a passion for the biopharmaceuticals industry. 1 of our clients is looking to add a strong Associate Director of Product Marketing to their team. Assignments include: 1) Support global strategic and tactical brand planning and budget processes 2) Create, manage and track budgets 3) Build compelling value propositions in line with brand strategies 4) Oversee and manage advertising agencies and other vendors 5) Lead, assist and execute marketing projects 6) Establish and manage global launches and tactical plans 7) Review and approve all project materials 8) Develop and implement marketing processes, programs and internal reports 9) Comply with company’s policies and procedures 10) Perform other duties as assigned

Senior Director of Regulatory Affairs (MyBiotechCareer)
Austin, TX -- Our client, a leading biotechnology company, is looking for a Senior Director of Regulatory Affairs with solid regulatory affairs background. Specifically, we are seeking an individual who is able to handle the following responsibilities: 1) Prepare cross-functional teams for interactions 2) Develop CMC regulatory strategies and programs 3) Comply with promotional and labeling regulatory qualifications 4) Develop and oversee regulatory budgets 5) Interact with domestic and foreign regulatory agencies 6) Direct and prepare CMC regulatory submissions 7) Negotiate and supervise regulatory activities 8) Communicate project status and issues 9) Ensure accuracy of regulatory filings 10) Perform other duties as assigned

Director of Engineering (MyBiotechCareer)
Austin, TX -- A leading company in the pharmaceutical industry is currently seeking a Director of Engineering to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Key duties include: 1) Maintain facilities, equipment and validation programs 2) Evaluate, specify and recommend new equipment for sites 3) Develop and implement strategies for optimizing resource utilization and key projects 4) Maintain up-to-date process documentation 5) Oversee change control programs associated with manufacturing facilities and computer systems 6) Plan, lead, execute and report on team’s activities 7) Oversee and direct engineering resources on sites 8) Achieve current and future objectives of the company 9) Maintain process control systems for critical operations 10) Implement and maintain data collection, measurement and process feedback mechanisms

Vice President of Regulatory Affairs and Quality Systems (MyBiotechCareer)
Austin, TX -- A leading company in the pharmaceutical industry is currently seeking a Vice President of Regulatory Affairs and Quality Systems to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Position assignments include: 1) Lead and develop regulatory strategies and plans 2) Assist in product submissions and periodic reporting and registrations 3) Lead and execute regulatory and quality projects 4) Interact with FDA and other regulatory agencies 5) Communicate with regulatory agencies regarding submissions 6) Maintain pre and post market QA and regulatory systems 7) Make sure FDA and other regulatory commitments are met 8) Direct meetings and teleconferences with regulatory agencies 9) Oversee and coordinate product and process development 10) Review and approve relevant regulatory and quality documents



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Austin
Organizations
ADP
AT&T Employment
Active Media (Internet)
Acuity
Ambion (Biotech)
American Bolt
American Health Supplies
American Society of Civil Engineers
Apple
Arrhythmia Research Technology
Austin American Technology
Austin Art and Artists
Austin - City Jobs
Austin Graphics
Avanti Technology
Beacon Development Tools
John Bernardoni Group (Media)
Brackenridge Hospital
Bridgepoint Technical Manufacturing
Briefcase of Talent (Media)
Children's Hospital of Austin
Compaq
Concurrent Design and Drafting
Congruent Technologies
CyberCorp (Now part of Schwab)
Davis Group (Media)
Dazel (Computer)
Deaton Engineering
Dell Careers
DuPont Photomasks
ELtech
Encotech Engineering
Enhanced Production Technologies
Espey, Huston (Engineering)
Excel Electronics
Faulkner Construction
Federal Express
FG Squared (Media)
FINLE Technologies
First Madison (Media)
Nancy Fly Agency (Media)
Flynn Construction
HP Plastics
Harvard Custom Manufacturing
High End Systems (Media)
Horizon Film & Video
Introgen Therapeutics
ISinc (3D Design)
JRL Systems
Steve Jackson Games
Jobs in Higher Education
 
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LTD Ceramics (Technology)
Le Chef College of Hospitality Careers
Luminex (Health)
Lyon Advertising
M3 Design
Makos Advertising
mc2 Advertising
MedTrans (Health)
McIntosh Advertising
McMillan Company (Technology)
Media Dimensions
Minco Technology Labs
Mytech (Technology)
National Instruments
NationsBank Recruiting
Nurse Week:Texas Jobs
Olive Design (Media)
Orion Scientific
Pavilion Technologies
Precision Medical
Professional Testing
Public Relations Job Bank
Reel Women (Media)
SI Diamond Technology
Salient Systems
Samsung Austin Semiconductor
SEMATECH
Sight and Sound (Media)
Silicon Resources
Silicon Hills Design
Society of Hispanic Professional Engineers
Socket Public Relations
St. Edwards University
Structural Engineers Associations of Texas
Symtx (Technology)
TechWorks
Tekmos (Technology)
Texas Music International
Tivoli Systems (Software)
Touch Systems
Travis County
Travis Technologies
Two Bit Computing
University of Texas
Venkel (Electronic Mfg)
Venture Four Architects
Waid & Asc (Engineering)
Wenzel Associates
Wid Industries
XeTel (Technology)
Zingaro & Company (Health)










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A summary of Austin, Texas

Austin is the capital of Texas, a state of the United States of America. With a 2000 population of 656,562 and a metro population of over 1 million people, Austin is the fourth largest city in Texas (behind Houston, Dallas, and San Antonio), and the 16th largest in the U.S. It is the county seat of Travis County.

Austin is located in Central Texas. It was first named Waterloo but was renamed in honor of Stephen F. Austin. Its original name is referenced in establishments such as Waterloo Ice House and Waterloo Records.

Austin is also the home of the University of Texas at Austin, the "flagship campus" of The University of Texas System. Like Madison, Wisconsin, Austin has been a heady mix of educators and their students, politicians and lobbyists. It is also the self-proclaimed "live music capital of the world", with a vibrant live music scene centered around many clubs on 6th Street and a yearly music festival known as South by Southwest.

Austin's biggest employers include the State of Texas, The University of Texas at Austin, Dell Computers, Motorola, and IBM. The region is known as Silicon Hills. There has been a lot of rapid development with the construction driving the city towards the north and the south.

The University of Texas has an outstanding Radio, Television, and Film (RTF) department and, largely because of this, Austin has been the location of a number of movies, including Spy Kids, Dazed and Confused, Office Space and Slackers. Austin is home to several famous directors such as Robert Rodriguez. Austin hosts the annual Austin Film Festival as well as the South by Southwest Festival which draw films of many different types from all over the world.

Austin is situated on the Colorado River, with 3 lakes within the city limits: Town Lake, Lake Austin, and Lake Travis. The city is also situated on the Balcones Fault, which runs the same route as Interstate Highway 35, Austin's main north-south artery. The eastern part of the city is flat while the western part and western suburbs consist of beautiful rolling hills. These unfortunately make the city vulnerable to flash floods. To control run-off and generate hydroelectric power, Austin has a series of dams run by the Lower Colorado River Authority.

Politics: Austin is administered by a non-partisan council of seven members, each of them elected by the entire city, and by an elected mayor. Under a tradition known as the "gentleman's agreement" which has existed since the 1970s, one of the council seats is contested only by an African-American while another council seat is contested only by a Hispanic. Political parties are not a major influence on city politics, and the main political actors within Austin are interest groups like the pro-environmental Save Our Springs Alliance.

The political controversy that dominated the 1990s was the conflict between environmentalists strong in the city center and advocates of more urban growth who tend to live in the suburbs. This conflict has been less heated in the last several years as the idea of smart growth has become popular.

Austin is served by the Austin-Bergstrom International Airport.

 

 


 
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