11 jobs found in charlottesville

Pharmaceutical Research Associates, Inc. Director of Drug Safety Center US-VA-Charlottesville US-PA-Blue Bell Job ID: 2019-57527 Type: US-Northeast # of Openings: 1 Category: Drug Safety PRA Health Sciences Overview This is an office-based position in either Blue Bell, PA or Charlottesville, VA. Who are we? We Are PRA. We are 16,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most. Who are you? You are an experienced drug safety leader who has led services such as providing aggregate safety reports, benefit-risk assessments, epidemiology reports, safety/risk management aspects of observational studies, signal detection and investigations, design and analysis of safety studies, Risk Management Plans (RMPs) and risk minimization activities applicable to drugs, biologics and devices throughout the life-cycle of a product. Responsibilities What will you be doing? Provides technical oversight to project teams and contributes to project deliverables in the areas of cumulative safety reports, benefit-risk assessments, epidemiology, signal detection and investigations, design and analysis of safety studies, risk management plans and risk minimization activities, pharmacovigilance audits and inspection preparation including generation of a project plan in close cooperation with project team. Supports the implementation of processes, systems and tools to improve efficiencies in company services. Participates in developing new and existing business by attending sales presentations. Ensures that project staff fulfills their responsibilities in accordance with company policies, procedures, and SOPs. Creates an environment that encourages learning, self-improvement, and career development for staff. Maintains familiarity with current industry practices and regulatory requirements that affect benefit/risk evaluations, NDAs/BLAs/MAAs, and changes to labeling and marketing authorization. Qualifications What do you need to have? Required An advanced degree (M.S. or Ph.D.) from an accredited institution in medicine, pharmacy or other life-sciences. Substantial experience in the pharmaceutical industry with at least 5 years of experience in a leadership position. Profound knowledge of regulatory requirements for human drugs, biologics, and/or devices. Proven history of successful interaction with internal and external customers. Effective written and oral communication and presentation skills. Reads, writes, and speaks English; fluent in host country language required. Substantial experience in project leadership and management of technical staff. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. Preferred Postgraduate degree in epidemiology, statistics or public health or equivalent degree preferred. Experience in interactions with regulatory authorities, IRBs/Ethics Committees, and medical community. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PI113637582

Pharmaceutical Research Associates, Inc. Clinical Trial Specialist 2 (Lenexa, KS) US-VA-Charlottesville Job ID: 2019-57296 Type: US-Northeast # of Openings: 1 Category: Clinical Trial Support PRA Health Sciences Overview Office Based in Lenexa, KS Who We Are: We Are PRA. We are 16,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most. Who You Are: You are known to friends and colleagues alike as the “go-to” person. You have excellent communication & follow-up skills. With your commitment to executing projects in accordance with the highest standards, you hold a certain reverence for the regulatory processes, SOPs and document trails that map out a pathway to compliance. But most of all, you are someone with tremendous potential who wants to apply your many talents in a role that will expand your fundamental knowledge of clinical research and provide you with the options and training to continue to grow in your career. Responsibilities What You Will Be Doing: As a Clinical Trial Specialist, you are the primary point of contact/liaison for the sites, Sponsor and internal stakeholders during the study life cycle. You will perform investigative site recruitment/feasibility, essential document collection and review, maintenance and close-out in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements. In addition, you will create and distribute meeting agendas and take meeting minutes during internal and Sponsor calls, roll out training plan to team members, and provide access to project systems. Senior-level Clinical Trial Specialists will manage all activities listed above, ensure that they meet Sponsor & PRA expectations, and deliver them in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs. Qualifications What You Need to Have: 1-3 years of relevant experience Undergraduate degree, health related preferred OR , an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job Prior experience using computerized information systems Clinical trials support, data coordination or pharmaceutical industry experience Experience with electronic data capture, PC Windows, word processing, and electronic spreadsheets preferred Knowledge of ICH and local regulatory authority drug research and development regulations preferred Ability to read, write and speak fluent English required To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PI113606129

Perrigo Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it. Job Overview: Position provides technical expertise and support to drug development programs executed by Strategic Partnership companies. The role assures Perrigo technical input into all aspects of drug development, FDA regulatory submissions and commercial product launch. As a result of the job responsibilities, this role may sit at a Perrigo site location or be remote, depending on the selected candidates qualifications and circumstances. Core Job Knowledge: Knowledgeable in topical/extended topical generic product development. Hands-on experience in designing / developing complex dosage forms and combination products. Ability to critically evaluate data, identify trends and draw accurate conclusions. Able to work through complex problems with a systematic approach. Competency in managing project milestones and timelines. Knowledgeable in FDA regulatory processes and ANDA data requirements. Strong interpersonal communication skills and well-developed collaborative management skills. Ability to work effectively across various drug development disciplines. Excellent writing skills in both technical and business writing. Education and Experience: Minimum B.S. degree in a scientific discipline and 8+ years of pharma industry experience. Responsibilities: Collaborate with partner to establish product development strategies, data expectations for FDA submissions, develop project timelines / milestones and commercial launch planning. Provide recommendations for pilot, exhibit, bio, scale-up batch and process validation strategies that satisfy all bioequivalence, submission and commercial launch requirements Technical review of product development reports, product characterization data, batch records, process optimization and validation reports. Propose solutions to unexpected product formulation, manufacture and testing issues. Perform on-site visits to partner manufacturing facilities to audit data and records Research and review technical literature e.g., summary basis of approval, Drug Master Files, related FDA guidance, applicable patents, bench-marking technologies, etc. Draft and edit technical responses to FDA review questions and meeting packages Support due diligence assessments on new partnership opportunities for the Rx business Additional Key Words: Generic drugs Topical products / Combination products Product development Project management Regulatory submissions Due diligence Equal Employment Opportunity/M/F/disability/protected veteran status. PI113301316

Pharmaceutical Research Associates, Inc. Budget Analyst US-VA-Charlottesville Job ID: 2019-57142 Type: US-Northeast # of Openings: 1 Category: Grants Management PRA Health Sciences Overview We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA. Who are we? We Are PRA. We are 16,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most. Responsibilities Who are you? You have a strong attention to detail, great time management skills and are focused. You are flexible and adaptable and can multi task with ease in a fast paced environment. You are proactive and can solve any potential problems with effective communication and team collaboration. You aim to produce the highest quality work, while maintaining professionalism, and courteous attitude with clients and our fellow team members. What will you be doing? Budget Analyst will create Investigator budgets utilizing available protocol information and the Fair Market Value System. The budgets created will support both the Proposals group for the BID process as well as the Contracts team for post-award work. Budget Analyst should be detail oriented, have exceptional Excel skills, creative problem solving abilities, and an interest in both budget analysis and clinical terminology. Qualifications What do you need to have? Qualifications: 1-2 years of experience negotiating site budgets (with sponsor and/or site). 1-2 years of experience creating site budgets. Read write and speak fluent English; fluent in host country language required. Bachelor’s Degree or international equivalent. Ability to read and interpret clinical protocol. Excellent written, oral communication and presentation skills; Proficient in Microsoft Excel, Access, and Word. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. Legal Statement: PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities PI113246072

Pharmaceutical Research Associates, Inc. Clinical Trial Specialist (Charlottesville) US-VA-Charlottesville Job ID: 2019-57295 Type: US-Northeast # of Openings: 1 Category: Clinical Trial Support PRA Health Sciences Overview Office Based in Charlottesville, VA Who We Are: We Are PRA. We are 16,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most. Who You Are: You are known to friends and colleagues alike as the “go-to” person. You have excellent communication & follow-up skills. With your commitment to executing projects in accordance with the highest standards, you hold a certain reverence for the regulatory processes, SOPs and document trails that map out a pathway to compliance. But most of all, you are someone with tremendous potential who wants to apply your many talents in a role that will expand your fundamental knowledge of clinical research and provide you with the options and training to continue to grow in your career. Responsibilities What You Will Be Doing: As a Clinical Trial Specialist, you are the primary point of contact/liaison for the sites, Sponsor and internal stakeholders during the study life cycle. You will perform investigative site recruitment/feasibility, essential document collection and review, maintenance and close-out in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements. In addition, you will create and distribute meeting agendas and take meeting minutes during internal and Sponsor calls, roll out training plan to team members, and provide access to project systems. Senior-level Clinical Trial Specialists will manage all activities listed above, ensure that they meet Sponsor & PRA expectations, and deliver them in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs. Qualifications What You Need to Have: 1-3 years of relevant experience Undergraduate degree, health related preferred OR , an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job Prior experience using computerized information systems Clinical trials support, data coordination or pharmaceutical industry experience Experience with electronic data capture, PC Windows, word processing, and electronic spreadsheets preferred Knowledge of ICH and local regulatory authority drug research and development regulations preferred Ability to read, write and speak fluent English required To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PI113213849

Krispy Kreme ID: 2019-9482 # of openings 1 Job Locations US-VA-Charlottesville Posted Date 08/26/2019 Department Company Store Operations Overview Overview of Position: Shift Supervisor BP -is responsible for overseeing the entire shift and ensuring that all operations run smoothly & efficiently in a Retail, Retail with Routes and Heritage store. Responsibilities Principal Duties and Responsibilities: Overseeing the proper performance of all store activities Training employees and ensuring that employees are working efficiently and effectively Maintaining adequate staff in retail and production positions Performing retail tasks as needed Performing production tasks as needed, if applicable to store type Ensuring customers are being cared for properly Ensure Production Specialists understand production schedule for the day, if applicable to store type Accessing the store's safe and getting change as necessary Ensure Krispy Kreme security & cash handling standards and procedures are met and enforced Locking doors and closing at night Conduct store tours Knowledgeable of Krispy Kreme history, product & current promotions Model exceptional customer service skills for employees Promote customer service oriented atmosphere in store Fill customer orders accurately and quickly, including products, condiments, and change Handle difficult customer situations professionally Maintain a pleasant and courteous demeanor Exhibit suggested selling behaviors such as: second dozens, up-selling other products, and up-selling in sizes Knowledge and ability to execute all store functions Answer telephone in a timely manner and utilize Krispy Kreme greeting procedures Other duties as assigned Equipment Operation Operate the POS system per standards identified in the Krispy Kreme Retail Specialist Workbook Operate other retail equipment, e.g. coffee and soda machines, in the proper manner Operate drive-thru equipment (POS and headsets) so as to achieve an average drive-thru time of 30-45 seconds or less Operate processing equipment while adhering to the company product standards identified in the Krispy Kreme Processing Specialist Workbook Ensure batteries are charged for drive-thru equipment Safety and Sanitation Maintain a clean, neat uniform at all times and ensure employees are also adhering to uniform standards Handle products per procedures identified in the Sales Specialist Employee Training Manual Utilize proper cleaning techniques as identified in the Sales Specialist Employee Training Manual Comply with sanitation standards Related Skills Complete a processing schedule as needed Must be able to perform all essential store functions Leadership Act as a team player through the standards identified in the Krispy Kreme Training Workbooks Assist in training and development of Team Members Handle customer and employee complaints or concerns professionally Assist management with staff scheduling and team-building Supports Managers with training of new employees Model company standards and policies consistently Model exceptional customer service skills for employees Assist with execution of corporate initiatives (i.e. Marketing, HR policies and procedures) Qualifications Essential skills and Experience: High school diploma or equivalent , preferred Must be 18 years of age or older Must perform all related competencies outlined in the Krispy Kreme Shift Management Training Workbook Strong leadership, organizational, and communication skills Experience working with people and history of dependability Must have flexibility to work any day or shift as needed Pass a pre-employment criminal background check Nonessential skills and Experience: Previous job stability preferred Physical Demands and work environment: Physical Activity The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Carrying • Bending • Stooping • Grasping • Standing • Twisting Lifting • Walking • Communicating with customers and co-workers • Sweeping Writing • Mopping • Driving • Packing doughnut boxes Physical Requirements Lifting up to 75 pounds occasionally; and /or up to 25 pounds frequently, physically active Using hand-trucks to push/pull products, often on ramps Visual Acuity Requirements Must be able to read and distinguish between products, product boxes, and labels Working Conditions: The worker is subject to inside and outside environmental conditions. Un-air conditioned production areas may reach temperatures of 100 degrees for more than one hour Krispy Kreme supports a diverse and drug-free workplace. EOE. E-Verify Employer. PI113177923

Pharmaceutical Research Associates, Inc. Records Analyst US-VA-Charlottesville Job ID: 2019-57222 Type: US-Northeast # of Openings: 1 Category: Other PRA Health Sciences Overview This position is for a Process Analyst for Records and Information Management. The Analyst, under direction, will manage records and information policies, retention schedules and records and information management practices based on agency mandates and industry best practices. Responsibilities Duties and Responsibilities (Including but not limited to) vary with specific position; Provide support for RIM projects by creating, updating and analyzing project information and reporting documentation. Manage records creation, maintenance, use, and ensure disposition are in accordance with federal guidelines through the creation of records retention schedules and assisting in the creation and updating of records and information management policy. Provide advisory service to PRA employees regarding records and information management policies, standards, and procedures. Collaborate strategies and participate in departmental goal setting Other duties as assigned Qualifications Education and Work Experience; Bachelor's degree or equivalent 5 + years of records and information management experience, preferably in the corporate environment Experience with assimilation of information from a wide variety of sources, analysis of business processes and the ability to research laws, regulations, and guidance that govern records globally. Less than 10% travel required. Knowledge, Skills and Abilities; Self-starter with the ability to function with a team and work effectively with others. Advance interpersonal, planning, project management, and oral and written communication skills; Experience in using Office 365 Suite Experience with developing retention schedules Experience in Legal research Paralegal not required but a plus Knowledge of Zasio’s Versatile database not required but a plus PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PI113187189

Pharmaceutical Research Associates, Inc. Accounting Specialist US-VA-Charlottesville Job ID: 2019-56110 Type: US-Northeast # of Openings: 1 Category: Accounting & Finance PRA Health Sciences Overview Who We Are: We Are PRA. We are 16,000 employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most. Who You Are: You are a numbers minded person who knows the difference between a pass through and a milestone, and is an Excel Pivot Table rock star! You are an effective communicator and recognize that our clients are our priority and can quickly work with them to answer questions via email or phone. You understand accounting and can lend your accounts receivable expertise to our team. You possess the ability to navigate and finesse delicate conversations when it comes to collections. You are flexible and adaptable and can multi-task with ease as you work with multiple project managers on multiple projects. You aim to produce the highest quality work, while maintaining professional and courteous communications with clients and our team members. Responsibilities What You Will Be Doing: Under general direction, responsible for the complex activities associated with billing and collections, and for ensuring compliance with company’s system of internal controls. Duties primarily involve the maintenance and oversight of payment schedules as per contracts, timely billing of Time and Material, Milestone and Pass-Through invoices, timely collection of outstanding invoices, and reporting of collection activity. Analyze client contracts, specifically payment schedules. Generate Time and Material, Milestone and Pass-Through invoices per contract. Answer sponsor inquiries and liaison between the project team and the sponsor. Monitor status of aging invoices and provide monthly explanation of unbilled in excess of 60 days old Track invoicing and collection history. Fulfill other assignments as are consistent with the scope of responsibilities of an AR Accounting Specialist. Qualifications What You Need To Have: Minimum of two years of experience in accounts receivable and collections or within an accounting department. Bachelors degree highly preferred Working knowledge of Microsoft Products: pivot tables, functions, formulas and macros in Excel a plus Experience in providing performing outstanding customer service, and in ensuring compliance with company’s system of internal controls is required. Must demonstrate excellent analytical and organizational skills. Must work effectively in a team environment. Must be able to work independently and with minimal supervision. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PI112985085

Pharmaceutical Research Associates, Inc. Grants Analyst US-VA-Charlottesville Job ID: 2019-57144 Type: US-Northeast # of Openings: 1 Category: Grants Management PRA Health Sciences Overview We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA. Who are we? We Are PRA. We are 16,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most. Responsibilities Who are you? You like analyzing data and can identify trends and forecast projects with confidence and accuracy. You are flexible and adaptable and can multi task with ease as you work on project cash flow, earnings, accruals and payment reports. You aim to produce the highest quality work, while maintaining professionalism, a courteous attitude and helpful communications with clients and our fellow team members. What will you be doing? The Grants Analyst will use clinical data and site specific contracts along with historical data to develop a well substantiated and accurate project specific investigator payment forecast. The Grants Analyst will provide expert and/or technical counsel to management and staff as needed regarding project cash flows, earnings, and historical trends. Duties may include but are not limited to: supplying client facing accrual reports, exhaustive project forecasts, and payments reports. Qualifications What do you need to have? 3-5 years of relevant experience. Bachelor’s Degree or international equivalent. Experience in providing outstanding customer service. Demonstrated experience performing complex financial reconciliations. Computerized software experience. Proficiency in spreadsheet software. Articulate and professional, and communicates in a clear and positive fashion. Read, write and speak fluent English; fluent in host country language. Ability to be proactive and show initiative. Ability to work with limited supervision. Proficient with Microsoft Office products. Especially Microsoft Excel & Access, preferred. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. Legal Statement: PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities PI112985003

Pharmaceutical Research Associates, Inc. Budget Coordinator US-VA-Charlottesville Job ID: 2019-57140 Type: US-Northeast # of Openings: 1 Category: Grants Management PRA Health Sciences Overview We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA. Who are we? We Are PRA. We are 16,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most. Responsibilities Who are you? You have a strong attention to detail, great time management skills and are focused. You are flexible and adaptable and can multi task with ease in a fast paced environment. You are proactive and can solve any potential problems with effective communication and team collaboration. You aim to produce the highest quality work, while maintaining professionalism, and courteous attitude with clients and our fellow team members. What will you be doing? Reviews executed contracts and associated budgets; partners with Project Managers, Clinical Team Manager, and Investigator Grant Team to interpret and determine appropriate budget setup methodology. Establishes budgets according to the agreed upon methodology in Clinical Trial Management System efficiently and effectively. Runs reports and determines necessary documents to collect that pertain to Payment Information and Contracts. Coordinates with legal team to obtain all necessary legal documents, including W8, W9, and payment information. Coordinates with Accounts Payable to obtain vendor numbers once all pertinent legal documentation has been received. Updates tracking database to support status reporting. Provides Help Desk support regarding budget setup/payment issues, as needed. Qualifications What do you need to have? Read write and speak fluent English; fluent in host country language required. Bachelor’s Degree or international equivalent. Ability to read and interpret clinical protocol. Excellent written, oral communication and presentation skills; Proficient in Microsoft Excel, Access, and Word. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. Legal Statement: PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities PI112985019

Location: Charlottesville, Virginia, 22911, United States Posted: 2019-07-19 Position Title: REI physician Company Name: Reproductive Medicine and Surgery Center of Virginia, PLC Sector: Medical Job Type: Full-time Job Duration: Indefinite Required Travel: 0-10% We are looking for a warm, energetic, and talented Reproductive Endocrinologist to add to our growing practice. This position is intended for a physician desiring partnership in the future- so you are truly invested in and rewarded by your contributions to the continued success of the practice, not just be an employee. This position is ideal for someone interested in a busy, comprehensive clinical private practice and with a valuable teaching role as a university adjunct professor. Benefits: We provide medical, dental, short term disability and long term disability, and a $95k life insurance policy at no cost for the employee. Employees can purchase vision insurance or additional life insurance. After one year of service, employees are able to participate in our 401K retirement plan with annual contributions from the practice. TO APPLY or for more information on this position, please contact Christopher Williams, MD, Director: (434)654-8524 or email at chris.williams@rmscva.com About Us: One of the earlier programs in the southeast, our clinic has been providing excellent IVF success rates and comprehensive REI care to a wide region in Virginia for over 31 years. Last year we performed over 400 IVF cycles combining fresh and cryo ART. We offer the most advanced and comprehensive aspects of care including PGT, gestational carrier, egg donation and significant surgical volume- including mullerian anomalies, tubal ligation reversal and advanced endoscopy. We have 3, highly experienced, full-time subspecialty certified Reproductive Endocrinologists. Reproductive Medicine and Surgery Center of Virginia, PLC, is a private practice but also provides the resident teaching and REI division for the University of Virginia, Department of Obstetrics and Gynecology, and we have faculty appointments. Charlottesville is a beautiful college town at the foot of the Blue Ridge mountains and in 2017 was named in the top 5 for lists of: "Best Place to Live in America," "America's Happiest Cities," and "Best Small Town in the South." All three physicians in the practice have children and have found this college town, and our practice, to be a wonderful environment to raise a family. PI112167112