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Aurobindo Pharma USA jobs in Durham, NC

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  • Assistant Scientist Analytical Inhalation, Research and Development-NC

    Aurobindo Pharma Ltd. 4.4company rating

    Aurobindo Pharma Ltd. job in Durham, NC

    Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Headquartered in HITEC City, Hyderabad, India, founded in 1986 and becoming a public company in India in 1992. Aurobindo Pharma USA, Inc. is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc. adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. Aurobindo has business operations in more than 125 countries around the world. Aurobindo is a global pharmaceutical company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages. Aurobindo markets over 80% of the top 100 most prescribed products in the world. In past years, Aurobindo has received more ANDA approvals than any of our competitors. Aurobindo is now ranked 2nd among pharmaceutical companies based on Total Prescriptions Dispensed. (We are#27 in 2010) Job Overview Capable of performing test methods for complex formulations under general oversight and documenting those experiments per cGMP requirements. Must be able to calculate, organize, and communicate results via standard data templates and reports. Experience in a cGMP laboratory and testing. Provide general laboratory assistance including planning, design and execution of experiments. Assist in editing of SOPs, protocol, methods, and reports. Responsibilities * Assist in or perform planning, design, and execution of experiments with guidance from supervisor/senior staff * Assist in edit of SOPs, protocol, methods, and reports * Provide general laboratory assistance across groups Qualifications - Skills & Requirements * Appropriate wet chemistry techniques. * Able to perform laboratory duties that require standing for 80-90% of the work day, lifting containers of 4+L of liquid, fine motor skills necessary for conducting laboratory experiments. * Must possess good organizational skills, a commitment to quality work, and good oral and written communication skills. * Must be able to work effectively as part of a team. PREFERRED * Experience with HPLC, GC, KF, FTIR, or other analytical instrumentation. Experience working with inhalation dosage forms. Work experience in a GMP and/or GLP environment. Able to wear a respirator. Education & Experience * Minimum - Bachelor's of Science Degree in Chemistry, Pharmaceutical Sciences, or related field with 1+ years of related experience. Physical Requirements LAB TECHNICIANS - Must be able to bend at the waist and knees as well as twist at the trunk. • Must practice good personal hygiene • Must be able to lift up to 25 lbs. • Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. • Position requires working in the laboratory as well as sitting Additional Physical Requirements Walking 1-4 HoursStanding 1-4 HoursSitting 1-4 Hours Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
    $50k-72k yearly est. Auto-Apply 12d ago
  • Multi-Specialty Account Manager - Toms River, NJ

    Lundbeck 4.9company rating

    Toms River, NJ job

    Territory: Toms River, NJ - Multi-Specialty Target city for territory is Toms River - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Atlantic City, Lakewood, Burlington. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable, and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! We are seeking a dynamic and results-driven sales professional with a proven track record of success who is looking to grow with LundbeckOur ideal candidate will have the ability to be a specialty product expert with an understanding of requisite market complexities in order to be successful promoting our products to stakeholders in the primary care and neurology settings. As an Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today's rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management where applicable. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university 2-5 years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience. Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually Self-starter, with a strong work ethic, tenacity, and outstanding communication skills Adaptability: Ability to embrace change and work collaboratively in a fast-paced team environment. Problem-Solving: Proven analytical skills to identify solutions and overcome obstacles. Data Analysis: Strong computer and technical skills used in analyzing data to develop both short- and long-term goals aligned with business objectives. Must live within 40 miles of territory boundaries Driving is an essential duty of this job; must have a valid driver's license with a safe driving record that meets company requirements Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck Ability to lift, bend, push, pull and move items including, but not limited to equipment, pharmaceutical samples, and any other work-related materials up to 25 lbs. with or without reasonable accommodation. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: Recent documented successful experience selling to general practitioners (GPs) and primary care centers. Prior experience promoting and detailing products specific to CNS/neuroscience Previous experience working with alliance partners (i.e., co-promotions) TRAVEL: Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range $108,000 to $125,000 and eligibility for a sales incentive target of $39,000. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.
    $108k-125k yearly 17h ago
  • Multi-Specialty Account Manager - Asheville, NC

    Lundbeck 4.9company rating

    Asheville, NC job

    Territory: Asheville, NC - Multi-Specialty Target city for territory is Asheville - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Black Mountain, Maryville, Sevierville, Newport, Hendersonville. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable, and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! We are seeking a dynamic and results-driven sales professional with a proven track record of success who is looking to grow with LundbeckOur ideal candidate will have the ability to be a specialty product expert with an understanding of requisite market complexities in order to be successful promoting our products to stakeholders in the primary care and neurology settings. As an Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today's rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management where applicable. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university 2-5 years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience. Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually Self-starter, with a strong work ethic, tenacity, and outstanding communication skills Adaptability: Ability to embrace change and work collaboratively in a fast-paced team environment. Problem-Solving: Proven analytical skills to identify solutions and overcome obstacles. Data Analysis: Strong computer and technical skills used in analyzing data to develop both short- and long-term goals aligned with business objectives. Must live within 40 miles of territory boundaries Driving is an essential duty of this job; must have a valid driver's license with a safe driving record that meets company requirements Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck Ability to lift, bend, push, pull and move items including, but not limited to equipment, pharmaceutical samples, and any other work-related materials up to 25 lbs. with or without reasonable accommodation. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: Recent documented successful experience selling to general practitioners (GPs) and primary care centers. Prior experience promoting and detailing products specific to CNS/neuroscience Previous experience working with alliance partners (i.e., co-promotions) TRAVEL: Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range $108,000 to $125,000 and eligibility for a sales incentive target of $39,000. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.
    $108k-125k yearly 4d ago
  • Design - Group Lead - Process

    IPS-Integrated Project Services 4.3company rating

    Cary, NC job

    Provides leadership of technical discipline and directs the day to day operational activities of the department. Responsible for delivery of target gross margin profits of the department. Manages staffing activities, including recruiting, retention and development of department staff. Actively manages department revenue growth and labor efficiency. Key Activities And Responsibilities Ensures the quality, accuracy, and completeness of overall work as to engineering, compliance with established IPS standards, procedures, codes, and ordinances. Primary responsible individual for quality of unit output related to adherence to stated project goals as well as legal and IPS guidelines and efficiency. (Accountability / Quality / Technical Standards Guidelines) Contributes technical input and oversees technical output of department to assure compliance with legal, IPS and project requirements. Protects IPS corporate welfare through application of prudent judgment and implementation of risk management technique. (Risk Management / Judgment) Coordinates and contributes technical input and oversees technical output of department to assure compliance with legal, IPS and project requirements. Oversees Peer Review program. (Technical Accountability / Quality) Develops and assures implementation of standards and tools to ensure department output meets or exceeds established quality and performance expectations. (Standards / Quality) Oversees manpower planning of unit resources and administer technical staff to assure efficient assignment of resources on multiple, concurrent projects. (Resources) Recruits, retains and develops staffing plans to meet forecast labor and skills required to meet business plan. Supervises designers and engineers and ensures that all employees within the department are properly managed, and trained. Instills a positive work environment and facilitates effective staff development efforts. (Staffing / Recruit /Retain /Training) Communicates staffing levels regularly with all levels of management at IPS. (Communication) Prepares proposals for service and supports preparation of proposals by others. Supports business development with presentations and related marketing activities. (Business Development) Special projects as assigned. Qualifications & Requirements REQUIRED EDUCATION/QUALIFICATIONS /WORK EXPERIENCE Bachelor's Degree in Chemical Engineering. Minimum of 15 years of diversified engineering experience, at least 10 of which have been in a supervisory or management capacity consisting of planning, designing and construction of engineering projects. Knowledge of system design, applicable codes and cGMP's as they affect process design and equipment specification. Progressive ability, capacity, and aptitude in administration to plan, organize, supervise, and coordinate technical work and to obtain cooperation from others. Analytical thinking, structured problem solving skills, superior communications skills, team building and strong work ethic. Must be able to build rapport with department staff CONTEXT AND ENVIRONMENT AND SAFETY Travel based on the project location. This position is a safety sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research or other "non-administrative" areas. DEMONSTRATED COMPETENCIES Must exhibit an entrepreneurial spirit by consistently seeking new opportunities to add value to the organization. Must strive for excellence in all aspects of job performance. Must approach their work enthusiastically with a contagious energy and drive that shows everyone they love what they do. Must display creativity and innovation by continually working to improve solutions, tools, methods and service delivery system. Must conduct oneself with an uncompromising commitment to the welfare of our clients and each other. Must act in an ethical, professional and respectful manner at all times. Must exhibit the ability to build and sustain long term relationships of mutual value through teamwork. Must be driven to succeed and committed to goal attainment. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
    $49k-105k yearly est. 2d ago
  • Lead, HCP Marketer

    EPM Scientific 3.9company rating

    Cary, NC job

    Lead HCP Marketer - Respiratory Therapeutic Area Purpose Our client is seeking an experienced Lead HCP Marketer to join a growing U.S. marketing team. This newly created role will focus on pre-launch preparation for respiratory products in the asthma and COPD space. The ideal candidate will bring expertise, strategic vision, and passion to help introduce our client and its products to the U.S. respiratory healthcare community. This position reports to the Head of U.S. Marketing and will include direct leadership responsibilities. Key Responsibilities Collaborate with senior leadership to develop go-to-market strategies and brand plans. Partner with Medical Affairs and Commercial teams to build relationships with key customers and opinion leaders in respiratory care. Lead and mentor a high-performing team, providing strategic direction and ensuring compliant execution of initiatives. Develop product positioning, messaging, and value propositions that resonate with target audiences. Oversee peer-to-peer and speaker program initiatives. Conduct market research and analysis to identify trends, customer needs, and competitive threats. Align closely with sales leadership and field teams to ensure effective customer engagement. Attend scientific meetings to stay informed on industry trends and emerging technologies. Work cross-functionally with patient marketing, digital/omnichannel, advocacy, customer experience, medical affairs, operations, and market access teams. Manage agency relationships with a focus on innovation and goal achievement. Ensure compliance with all regulatory, legal, and corporate requirements. Engage in customer-facing activities such as field rides, meetings, and events. Contribute to leadership presentations and launch readiness updates. Experience & Qualifications 6+ years of pharma HCP marketing experience. Previous product launch experience in asthma or COPD. Proven success in leading marketing projects and managing multiple priorities. Strong strategic and creative thinking skills. Ability to pioneer innovative projects and support thoughtful risk-taking. Excellent communication skills (verbal and written). Experience working with field-based teams. Proficiency in marketing automation platforms, CRM systems, and related tools. Thorough understanding of regulatory, legal, and compliance requirements. Ability to navigate medical/legal/regulatory processes collaboratively. Strong relationship-building and influencing skills. Ability to work independently with minimal guidance. Flexibility to travel (up to 30% if based near HQ; more if remote). Preferred: People management experience, AGILE marketing, digital expertise. Education Bachelor's degree in Marketing, Communications, Business, Life Sciences, or related field.
    $50k-102k yearly est. 4d ago
  • Senior Process Piping Designer

    IPS-Integrated Project Services 4.3company rating

    Cary, NC job

    At IPS, you'll apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities. We're looking for an experienced Senior Process Piping Designer to join our talented team at our office located in Cary, NC. As a Senior Piping Designer, you'll work independently on conceptual and detailed design projects as assigned by a Project Manager or Lead Designer. You'll play a crucial role in the entire design process including preliminary assessments, concept creation, design, problem resolution, and customer and vendor accessibility. You'll prepare piping and equipment arrangement drawings in 3D Models and 2D layouts. We'll rely on you to select the right piping components such as GMP valves, fittings, flanges, and pipe supports, working with equipment suppliers/vendors to get the information needed for design completion. You'll produce Piping Plans, Equipment Layout, Section Layout, Section Views, and other 2D drawings for deliverables. You'll also prepare material take-offs. You'll ensure acceptable levels of quality and check for coordination of work to ensure documents reflect design intent. The team will rely on you to coordinate all aspects of project document completion within the company and externally with clients and other design professionals; this includes coordinating design work with related engineering disciplines to resolve clashes and apply comments. You may contribute to annual performance reviews for assigned staff, if applicable, along with acting as a resource for developmental support. Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and continue to build upon your successful career! You'll be expected to travel for occasional meetings and site visits (around 5-15% of your time). Qualifications & Requirements 8 years of previous design experience. Technical or Associate Degree from an accredited technical institution or college in engineering design areas of Mechanical. Experience with generating Piping Iso drawing production. Experience with Autodesk Navisworks. Preferred Qualifications Knowledge of the design of Piping Systems for GMP Process and Clean utility systems. Proven experience with Piping Design software; Plant 3D experience. BIM 360 experience. IPS will not sponsor employment visas for this position. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
    $105k-147k yearly est. 4d ago
  • Senior Construction Scheduler (Utilities)

    IPS-Integrated Project Services 4.3company rating

    Somerset, NJ job

    At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Senior Construction Scheduler to join our talented team at our office located in Somerset, New Jersey. Additional Responsibilities Develops, monitors, and updates project plans & schedules encompassing the entire engineering, procurement, construction, and qualification (EPCQ) life cycle. Analyzes schedule input from project partners, including clients, internal teams, vendors, and contractors, to verify schedule durations and integrity as well as evaluate the logic and float paths. Integrates data into an overall master schedule and ensures the credibility of the information in the master schedule. Makes recommendations to manage float and (re)sequence activities to achieve project milestones/target dates. Collaborates with the team to support constructability and value engineering. Baseline schedules and document the basis for approval. Monitors schedule progress, deviations, and variances and assesses impacts on the critical/near-critical path activities. Assists in developing alternatives for corrective action. Performs job site walks to verify the physical progress of scheduled activities and analyze change orders for schedule impacts. Continually progress & review schedules with the project team to ensure accurate and timely data is incorporated and forecasted. Ability to generate earned value, SPI, CPI, and other schedule metrics. Prepares schedule progress reports, trending charts, and schedule analysis. Maintains record of scope changes, trends, and variances that potentially affect schedule performance. Collaborates with all groups to improve company processes, systems, and intellectual infrastructure to promote organizational learning and continuous improvement. The salary offered for this role is between $120,000 and $150,000, but the actual salary offered is dependent on skills, experience, and education Qualifications & Requirements Bachelor's degree in engineering or a related technical field, construction management, or applicable experience. 7+ years of experience as a planner/scheduler on facilities capital projects. Demonstrated knowledge of engineering, procurement, construction, and qualification (EPCQ) processes. Understanding of engineering and construction methodologies and technical documentation. Demonstrated expertise in the use of modern planning and scheduling principles, methodologies, techniques, and tools, including CPM, Last Planner, 4D, etc. Strong analytical and computer skills with demonstrated proficiency in Primavera P6 Planner, Microsoft Project & Office Suite programs. Preferred Qualifications Knowledge of vPlan, BIM 360, and other visual & collaborative planning tools. PMI or AACEI certification. Experience in the pharma/biotech industry. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
    $120k-150k yearly 4d ago
  • Senior Cost Controller (Utilities Construction)

    IPS-Integrated Project Services 4.3company rating

    Somerset, NJ job

    At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Senior Cost Controller, PJC, to join our talented team at our office located in Somerset, New Jersey. In this role, you will be assigned to projects to review, coordinate, and summarize the activities of cost control, planning and scheduling, document control, and estimating. Additional Responsibilities Supervise the Project Control and Estimating personnel assigned to the project. Identify and analyze potential project problems. Recommend corrective action and follow up on recommendations. Motivate subordinates to meet project objectives. Promote communication and teamwork within the group and project. Experience in developing and managing the following: Project scheduling using the Critical Path Method (CPM) Experienced in Earned Value Management (EVM) Calculating Risk and Risk Management Time Phased Cost Forecasting Subcontractor Invoicing Change Order management RFP/Bid preparation and analysis Produce the project cost and progress reports for the Project Manager and Client Produce and maintain the Project Control Execution Plan. Qualifications & Requirements 16+ years of professional experience. Bachelor's degree in a technical field: engineering, project management, construction management. Experience in developing and managing multiple concurrent projects and developing and executing PMO best practices. Experience in all facets of Engineering, Procurement, and Construction Management (EPC). High level of computer expertise in multiple industry-wide software products, such as: MS Office Products Scheduling software such as Primavera and MS Project Client ERP systems such as JDE, QUAD, SAP, ARIBA, CONCUR PPM Software: Prolog, Proliance, Prism G2, Procore, Cleopatra, Cora Systems Context, Environment, & Safety A safety-minded individual who must comply with the IPS Mission Zero Safety policy. Capable of working alone or as part of a team without a significant level of supervision. The employee is frequently required to stand, walk, and sit for long periods of time with extended computer use. Experience working in both a Home Office and a Field environment. Travel to client sites as needed. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas. The salary offered for this role is between $100,000 and $140,000, but the actual salary offered is dependent on skills, experience, and education All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
    $100k-140k yearly 4d ago
  • Senior Plumbing and Fire Protection Engineer

    IPS-Integrated Project Services 4.3company rating

    Cary, NC job

    At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities. We are looking for a talented Senior Plumbing and Fire Protection Engineer to join our team at our office located in Cary, North Carolina. In this role, you will work independently on various projects as assigned by a Project Manager or group leader. You will also play a role in the entire design process including but not limited to preliminary assessments, concept creation, design, problem resolution, and customer and vendor accessibility. Additionally, you may work on several concurrent projects and at times may assist as a technical expert on a specialized design. What You'll Do Assign and review the work of the project design team. Check the progress of work and alert the Project Manager to changes in scope or additional services. Attend pre-bid meetings and assist the project team in evaluating commercial proposals. Assess the requirements of a project, break a project into tasks, and work with a Project Manager to determine the scope of work, budget, and staffing. Write the scope of work for plumbing and fire protection designs based on preliminary reviews and meetings with the clients. Develop design concepts and prepare documents during the design development phase. Correct and update design documents. Develops solutions to design problems. Prepare engineering studies and schematic designs for new systems and analyze the operation of existing systems. Use computer-aided design technologies to develop sketches, drawings, and construction documents. Review drawings and documents to ensure compliance with company design and production standards. Work with equipment suppliers/vendors to obtain the necessary information needed for design completion. Interacts with clients regularly to secure scope and design intent. Ensure acceptable levels of quality and check for coordination of work to ensure documents reflect design intent and necessary coordination. Coordinate all aspects of project document completion within the company and externally with clients and other design professionals. Coordinate design work with related engineering disciplines. Attend job and construction meetings and participate in the coordination of the work. Contribute to annual performance reviews for assigned staff. Assist in the education and development of design staff and act as a resource for design questions. Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights! Qualifications & Requirements 8+ years of previous Plumbing and Fire Protection Engineering and Design experience. Bachelor of Engineering Degree from an accredited University or relative trades experience Registered Professional Engineer (PE). Has previous experience working for an Architectural and Engineering firm (A&E). Is proficient in the use of computers for design and understands CAD operations. Has knowledge of all aspects of plumbing and fire protection systems; including Sanitary and Vent Systems, Storm Systems, Process Waste Systems, Lab and Vent Systems, Domestic Water Systems, Process and Lab Gas Systems, Sprinkler Design, and Wet/Dry/Pre Action Systems. Is able to produce calculations for the above systems. Has a demonstrated ability to manage projects, problem solve, and communicate effectively to all key personnel and time manage. Able to travel up to 25%. IPS will not sponsor employment visas for this position. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
    $64k-94k yearly est. 4d ago
  • Contract Analyst

    IPS-Integrated Project Services 4.3company rating

    Somerset, NJ job

    At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented Contract Analyst to join our team at our office located in -------------------Somerset, New Jersey. In this role, you will leverage extensive professional experience and skills, and can work autonomously or in a team environment. You will report to a Manager of Project Controls and administer contract and purchase order flow by departmental SOPs, policies, and project-specific requirements. You will also act as quality assurance (QA) checks on all contracts and purchase orders. Additionally, you will guide internal and external stakeholders on contract management requirements, including corrective actions to key contract elements that do not meet project and/or IPS standards. Additional Responsibilities Bid Scopes of Work: Work with the project team to prepare SOW documents to attach to the Requests for Proposals (RFP). Recommendations To Award (RTA): Prepare or assist in the preparation of RTA. Work with the Project Team to prepare this document. Conformed Scopes of Work (SOW): Draft and finalize. Change Order Management: Review change order request (COR) documents for compliance with the contract documents. Prepare all necessary documents to process change orders to purchase orders. Contract Management/Support Documentation: Draft letters or related correspondence to support adherence to contract terms and conditions. Contractor Feedback Documentation: Collect, store, and report on feedback detailing contractor performance. Participate in weekly engineering meetings between project management, project engineering, project controls, Company procurement, licensing and permitting, Company corporate properties, the Company's engineering contractor(s), and other project stakeholders. Communicate daily with the project management team, project Engineering, Company engineering contractor, and other project stakeholders. Support the project management team in assessing critical path and near-critical path work with alignment and coordination of all on-site resources throughout the construction and commissioning phases of the project. Assist in interfacing with the Company's engineering contractor and the Company's engineering department, to assess engineering deliverables and schedules, to ensure design management and coordination of all project stakeholders, with Issued for Construction (“IFC”) documents, timely resolution of Requests for Information (“RFI”), control of Engineering Change Notices (“ECN”) and red lines, and timely resolution of Non-Conformance Reports (“NCR”). Assist in the creation and management of the following: Project Scope Document and participate in the procurement of all stakeholder signatures. Project Execution Plan and participate in the stakeholder approval process. Risk Register and participate in the stakeholder approval process. Assist in the engagement of the Company's: Corporate Properties group in the project and communicate directly to ensure that the project's needs for temporary/permanent easements. Legal group in the Project and communicate directly to ensure that project needs are established and met. Applicable Division(s) in the Project and communicate directly to ensure that project needs are established and met The salary range for this role is between $140,000 and $150,000, but the actual salary offered is dependent on experience, skill set, and education. Qualifications & Requirements 10 - 15 years of professional experience in the Utility Environment. Bachelor's degree in a technical field: engineering, project management, construction management. Software skills: MS Office Products at a minimum, industry-related software products. Demonstrates project management experience. Basic working knowledge of electric distribution systems, and civil construction. Knowledge of specification and contract enforcement, applicable technical standards, OSHA, and other regulatory statutes. Knowledge of trade agreements, procedures, techniques, work methods, and standards used in the construction industry. Administrative skills for effective monitoring of contractor progress, cost control, and contractual interpretation matters. Preferred Qualifications Membership in a professional organization such as AACE, ISPE, etc. Professional credentialing (CCT or CCP, CST or CSP, EVP, CMIT or CCM, PMP, EIT). SAP experience. Context, Environment, & Safety A safety-minded individual who must comply with the IPS Mission Zero Safety policy. Capable of working alone or as part of a team without a significant level of supervision. The employee is frequently required to stand, walk, and sit for extended periods with extended computer use. Experience working in both a Home Office and a Field environment. Travel to client sites as needed. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
    $140k-150k yearly 1d ago
  • Quality Control Manager

    IPS-Integrated Project Services 4.3company rating

    Cary, NC job

    At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Quality Control Manager to join our talented team at our office located in Cary, North Carolina. In this role, you will use your technical knowledge and skills to effectively train, supervise, communicate, execute, and manage the IPS Construction Quality Control and Quality Assurance (QA/QC) program for ongoing Construction Projects. This is a leadership role responsible for working with the On-Site Construction Management Team to ensure the established project standards are followed. Additional Responsibilities Develops, plans, manages, and administers the implementation of project-specific Construction QA/QC Plans with the CM team, contractors, and clients. Trains the project team on their criteria and implementation. Develops special Inspection Test Plans and System Completion records that will be incorporated into the QA/QC project-specific plans. Reports and publish quality reports, audits, and initiatives to the Project Manager and review with the project team prior to publication. Ensures Corporate Quality initiatives and goals are achieved. Develops a system to compile, monitor, track, and confirm deficiencies and successes of work performed by direct-hire and subcontract work crews. Evaluates testing, sampling methodologies, technologies, and equipment to confirm correct applications are implemented. Reviews utility matrices developed to start up and commission systems and skids. Directs the tracking of deficiencies, test results, or other regularly reported quality control data. Manages non-conformance reporting activities and tracks efficiencies from identification through resolution. Monitors performance of quality control systems to ensure effectiveness and efficiency. Verifies that the construction of systems and equipment are installed in accordance with approved construction documents. Reviews plans and specifications to ensure requirements are met for each construction process. Understand and apply federal, state, and local codes, policies, laws, and regulations. Identifies quality problems or areas for improvement and recommends solutions. Assists in performing system walk downs/final inspections; closeout and startup; establishes system completion punch list items; and, ensures all deficiencies are corrected. Attends pre-construction and construction meetings noting areas/topics that may present future problems/risks and present to the project manager for consultation. Implements the corporate safety culture and principles into the QA/QC programs. Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights! Qualifications & Requirements B.S. in a Science, Engineering, Construction management, or related field. Quality Assurance and Quality Control Management training and experience with 15 years of field experience in construction and/or engineering. Strong knowledge of applicable regulatory guidelines within the construction safety and pharmaceutical industry along with the ability to interpret complex issues and provide recommended courses of action. Proficient skill level in Microsoft Office Suite. Preferred Qualifications First Aid/CPR training. Primavera P6 and MS Project knowledge. Commissioning and System startup experience. Safety You will travel 50% of the time, or as necessary to complete duties. You may be assigned to a client for an extended period of time (1-2 years). OSHA 10 certification (IPS will provide tools) must be maintained during employment. Overnight travel is possible. You will focus on construction field activity and office time will be limited. You will visit Client sites and will be required to adhere to stated safety rules. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
    $78k-112k yearly est. 3d ago
  • Network Engineer

    Octapharma Plasma, Inc. 3.8company rating

    Charlotte, NC job

    How to Maximize your opportunity to do rewarding work, your future leadership potential, and your career growth? Join an industry leader. [Become one, too!] Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role: Network Engineer Onsite Charlotte, NC This Is What You'll Do: Plan, design, implement and manage network systems and their corresponding or associated software in a primarily Cisco environment, including firewalls, VoIP and unified communications, wireless, switching/routing and end-point protection while assuring system performance and Work with WAN provider, coordinate WAN activities, and manage communications vendor Assist in the documentation and implementation of best practices for network design and management, LAN switching, cable management, and fault detection and correction under the leadership of the Manager of Operations and Delivery. Monitor and maintain overall network/infrastructure health and performance. Perform network and Server administration Perform performance reporting and analysis on both Network and Windows server systems. Support integration of new businesses in both planning and field work. Provide augmentation for help desk Support Analysts in answering and resolving reported Tier One and Tier Two Is able to resolve most user reported infrastructure issues, but may require the assistance of Senior Engineers to resolve Tier 3 problems. If needed, work with the hardware/software vendor support for problem resolutions. Able to define advanced troubleshooting techniques to quickly isolate and resolve reported infrastructure issues, except those requiring advanced Network or Server skills. Support both a corporate office environment and a significant number of remote locations. Complete installation of all donor center, server, or network equipment or the installation of Understand the various networking principals including data center architecture, LAN configuration, WAN configurations using MPLS and VPN, QoS, VoIP etc. to support corporate office and remote locations. Provide technical thought leadership and evaluate different solutions/vendors/designs to determine the best solution for the business needs. Provide routine reporting and analysis of network information and performs root cause analysis of recurring problems. Develop performance and service level objectives under the direction of the Manager, IT Provide IT operations support, which may include: collecting and reporting performance data, outage data, review of error logs and backup logs, and other monitoring as assigned and can provide assessment of results and recommendations for improvement. Configure test environments on a continual basis. Control and maintain an up-to-date library of product releases, service packs, hot fixes, patches, Installs new equipment as it arrives. Place support calls with vendors as needed on new and existing equipment. Maintains all lab equipment - troubleshoots and repairs faulty equipment as needed whether it be hardware or software related. Assist in the scheduling of out of town assignments, on-call support, and off-hour change requirements. Assist in the implementation and documentation of best practices in infrastructure maintenance and support. This Is Who You Are: Strong leadership and organizational development skills Deep understanding of enterprise IT systems, software, and data management Expertise in infrastructure architecture and security governance Proficient in project and budget management Strong negotiating and vendor management capabilities Excellent written, verbal, and interpersonal communication skills Ability to present technical concepts in business-friendly language Self-motivated with exceptional problem-solving and analytical abilities Committed to delivering high-quality service and continuous improvement Knowledge of applicable data privacy, security, and compliance laws Collaborative, with a demonstrated ability to lead cross-functional teams This Is What It Takes: Bachelors Degree in Information Technology or related field of study, or equivalent industry Minimum of four (4) years experience performing Network support in a comparable Experience with Cisco router, switch, and VoIP installation and Demonstrated administration of Cisco Call Manager, Unity, and IOS. Knowledge of Cisco ASAs, ACLs, IDS and other security functions. Demonstrated participation in the on-call support schedules for Network and/or Knowledge of IP, OSI model, MPLS, Frame Relay, VLANs, VOiP, quality of service, as well as PC, and Server hardware. Ability to acquire an understanding of the needs and restrictions of a FDA, GxP Excellent verbal, written and interpersonal communications Experience in performing root cause analysis for service interruption recovery; create preventative measures on complex projects. Demonstrated flexibility to changing priorities. Will be required to work outside of Normal Business hours, primarily in the event of an emergency or implementation of new systems/upgrades which will need to be done after hours. On-call support that may involve night or weekend coverage as CCNA (Routing & Switching) certification required. CCNA (Voice) certification preferred. Do Satisfying Work. Earn Real Rewards and Benefits. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Formal training Outstanding plans for medical, dental, and vision insurance Health savings account (HSA) Employee assistance program (EAP) Wellness program 401 (k) retirement plan Paid time off Company-paid holidays Personal time More About Octapharma Plasma, Inc. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch. Interested? Learn more online and apply now at: octapharmahiring.com And if you know someone else who'd be a great fit at Octapharma Plasma, Inc., please forward this posting along. INNER SATISFACTION. OUTSTANDING IMPACT.
    $64k-83k yearly est. 4d ago
  • Asst Director Patient Care - Adult Psych

    Central Jersey Behavioral Health 4.0company rating

    Toms River, NJ job

    Job Title: Asst Director Patient Care Department Name: Adult Psych (AP) Status: Salaried Shift: Day Pay Range: $121,935.00 - $156,140.00 per year Pay Transparency: The above reflects the anticipated annual salary range for this position if hired to work in New Jersey. The compensation offered to the candidate selected for the position will depend on several factors, including the candidate's educational background, skills and professional experience. RWJBarnabas Health is seeking a highly dedicated Assistant Director for the Adult Psych department at the Barnabas Health Behavioral Health Center. The Barnabas Health Behavioral Health Center (with Monmouth Medical Center Southern Campus Behavioral Health Services) constitutes a freestanding 100-bed acute care psychiatric facility which provides inpatient and intensive outpatient programs for adults and older adults diagnosed with psychiatric and dual disorders. As an integrated healthcare system with an outstanding national reputation, we're proud to offer nursing opportunities on a scale few healthcare systems can match! We welcome you to come and be part of a team that offers professional growth opportunities, as well as a working culture that places a high value on teamwork and relationship-building. Our Registered Nurses assess, plan, implement, and evaluate nursing care for psychiatric patients in accordance with the Nurse Practice Act for the State of New Jersey and the policies and procedures of the Barnabas Health Behavioral Health Center. All methods of practice shall conform to written hospital policies and procedures and be carried out to the highest achievable level of competence in a manner demonstrating concern and consideration. The Registered Nurse will demonstrate Barnabas Health's philosophy to Total Quality Management by actively applying that philosophy in all dealings with both internal and external customers. Qualifications: Required: ASN or Nursing Diploma Three (3) years behavioral health nursing experience with at least one year of management experience Certifications and Licenses Required: BLS certification Active New Jersey Registered Nurse License Preferred: BSN Scheduling Requirements: Day shift, 40 hours per week Essential Functions: Directs patient care in a manner which ensures that: Standards of patient care and regulatory agencies are met, The nursing process forms the basis for delivery of patient care, Patients, their families/significant others and associates are treated with dignity, respect and compassion, Integrates department s services with the facility s primary functions, Develops and implements policies and procedures that guide and support the provision of services, Recommends space and other resources needed by the department, Promotes staff effectiveness/competency through goalsetting, role modeling and provision of learning opportunities, Provides nursing administrative coverage as assigned, Interviews, selects, promotes and terminates staff per established hospital policies and Federal/State laws, Determines the qualifications and competence of department personnel who provide patient care services and who are not licensed independent practitioners, Provides for orientation in-service training and continuing education of all persons in the department, Promotes quality of patient care through the following: Develops/revises plan for patient care delivery in assigned areas, Identifies and corrects actual/potential problems, Recommends/selects appropriate indicators to measure performance, Communicates QA & I findings as required, Ensures the provision of Patient Family education, Benefits and Perks: At RWJBarnabas Health, our market-competitive Total Rewards package provides comprehensive benefits and resources to support our employees' physical, emotional, social, and financial health. Paid Time Off (PTO) Medical and Prescription Drug Insurance Dental and Vision Insurance Retirement Plans Short & Long Term Disability Life & Accidental Death Insurance Tuition Reimbursement Health Care/Dependent Care Flexible Spending Accounts Wellness Programs Voluntary Benefits (e.g., Pet Insurance) Discounts Through our Partners such as NJ Devils, NJ PAC, Verizon, and more! Choosing RWJBarnabas Health! RWJBarnabas Health is the premier health care destination providing patient-centered, high-quality academic medicine in a compassionate and equitable manner, while delivering a best-in-class work experience to every member of the team. We honor and appreciate the privilege of creating and sustaining healthier communities, one person and one community at a time. As the leading academic health system in New Jersey, we advance innovative strategies in high-quality patient care, education, and research to address both the clinical and social determinants of health. RWJBarnabas Health aims to truly make a unique impact in local communities throughout New Jersey. From vastly improving the health of local residents to creating educational and career opportunities, this combination greatly benefits the state. We understand the growing and evolving needs of residents in New Jersey-whether that be enhancing the coordination for treating complex health conditions or improving community health through local programs and education. Equal Opportunity Employer
    $53k-66k yearly est. 5d ago
  • Pharmaceutical Sales Representative, Endocrinology (Rare Disease) - Charlotte

    Xeris Pharmaceuticals 4.2company rating

    North Carolina job

    Achieve territory sales goals by promoting products and services to physicians and other medical personnel within assigned geography. Educate customers on the appropriate use, characteristics, and approved indications of products. Professionally represent the company and ensure high levels of visibility and customer service in territory. Maintain effective communication and relationships with key external and internal customers. Responsibilities Effectively promote and educate specialty physicians on the appropriate use of rare disease products through one-on-one meetings and group presentations, company-approved promotional speaker programs and other company-approved means. Responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics. Ensure high performance levels of call and field productivity. Meet territory product sales goals while adhering to all defined ethical sales practices, compliance guidelines and required promotional regulations Execute company-approved Product Marketing plans and territory/regional business plan activities Support targeted customers and accounts using company-approved resources, sales materials and promotional activities/programs/initiatives as identified by Sales Leadership Appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc.) according to defined company compliance guidelines Ensure optimum territory sales strategy execution using territory business plans, regional business plans and all appropriate sales reports Communicate cross-functionally to gather knowledge of best practices from peers within the organization. Attend all company-sponsored sales and medical related meetings as directed by company management. Actively pursue continuous learning and professional sales development on effective sales/communication techniques and product/therapeutic area knowledge. Qualifications BA/BS required 5-7+ years of successful pharmaceutical sales experience required. Previous experience in competitive markets preferred Proven record of sustained high sales performance and achievement (Top 10%, National Awards) 2+ years of experience promoting rare competitive disease products strongly preferred A valid, US State-issued driver's license is required Launch experience or start-up experience is a plus Experience working with Endocrinologists preferred Deep understanding of all stakeholders in an office and ability to support them in getting a patient started on therapy within guardrails established by the company Demonstrated ability to both build relationships within existing accounts as well as proactively find new accounts Previous experience working with specialty pharmacies and internal patient support roles preferred Experience navigating managed care and rare disease products preferred At Xeris, performance consists of both results and behaviors. Behavioral competencies include: Leadership skills, Teamwork & Collaboration, Attention to Detail, Self-Starter, Problem Solving, Organizational skills, Adaptability, Professionalism, Written and Verbal Communications, Adherence to compliance policies and processes, Analytical skills, Multi-Tasking skills, Decision-making skills, Accountability, Inquisitive Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Position requires vehicle travel, as necessary. Travel approximately 70%. The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-REMOTE As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $110,000 to $190,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for commission and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process. NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
    $46k-65k yearly est. Auto-Apply 60d+ ago
  • Senior CQV Engineer

    IPS-Integrated Project Services 4.3company rating

    Cary, NC job

    At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented Senior CQV Engineer to join our team at our office located in _____________. In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. You will also follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. You may also perform standalone commissioning services for non-FDA-regulated clients. Additional Responsibilities Write C/Q/V documents following established standards and templates, including but not limited to the following: Commissioning Forms C/Q/V Protocols and Summary Reports Standard Operating Procedures Impact Assessments Specifications (URS/FRS/DDS) FATS/SATs Perform field/site activities including, but not limited to, the following: Attend and witness FATs and SATs as a representative of IPS clients. Execution of commissioning forms and witnessing of vendor start-up and testing. Execution of C/Q/V protocols. Walkdown and verification of system drawings (P&IDs, as-builts, etc.) Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc. Assist in deviation investigation and resolution of problems and issues encountered during field execution activities. Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required. Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries. Read, understand, and utilize the IPS Best Practices and SOPs for the delivery of compliance services Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested. Come join our dynamic team that creates world-class designs for our clients, and propel your career to new horizons! Qualifications & Requirements Bachelor of Science in Engineering. This is an entry-level position. 7 or more years of relevant experience. Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. Preferred Qualifications Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software. General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA. Context & Safety This position will have up to 100% travel to the site, or as required by the assigned project. You may be assigned to a client site for an extended period. Overnight travel or staying in the city of the client's location is possible depending on the assignment. Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan. You may visit active construction sites and will be required to take site safety training and adhere to site safety rules. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
    $80k-108k yearly est. 1d ago
  • Project Manager (Utilities Construction)

    IPS-Integrated Project Services 4.3company rating

    Somerset, NJ job

    At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Project Manager to join our talented team at our office located in Somerset, New Jersey. In this role, you will manage project coordination with Inside Plant (“IP”) Construction and Outage Planning, the engagement of various internal departments in the project, and communicate directly to ensure that project support needs are met by internal departments. You will also manage Project Engineering in the development of the Material Tracking Log (“MTL”), support all material procurement activities, and ensure that the MTL is maintained throughout the Project lifecycle. Additional Responsibilities Organizes weekly engineering meetings between Project Management, Project Engineering, Project Controls, Procurement, Licensing and Permitting, Corporate Properties, and the Architectural Engineering (“A&E”) firms. Ensures the creation and distribution of weekly action item lists to project stakeholders. Coordinates daily communication between the Project management team, Project Engineering, and the A&E firms. Creation and management of the Project Scope Document, and participation in the procurement of all stakeholder signatures. Creation and management of the Project Execution Plan and Risk Register, and participation in the stakeholder approval process. Review Contractor submittals, including monthly reports, schedules, and cash flow documents. Manage the following: facilitation of design reviews by the Project Engineering Division, and ensuring that everything is signed by the appropriate parties the development of monthly reports for the project and engaging all stakeholders in contributing to their individual sections the facilitation of project detailed design by the A&E firm, and support the preparation, development, and review of technical specifications the execution of the Quality Assurance and Control Plan Project closeout activities, including lessons learned meetings, the submittal of As-Built drawings, documentation turnover, and the closeout of all permits and purchase orders. Support site construction management in verifying that construction activities comply with design and specifications, and support the execution of the detailed commissioning and testing plan. Support the documentation of all lessons learned activities in the Company database. The salary range for this role is between $120,000 and $150,000 but actual salary offered is dependent on experience, skill set and education. Qualifications & Requirements 15+ years of professional experience. Bachelor's degree in a technical field: engineering, project management, construction management. Professional credentialing is strongly encouraged (CCT or CCP, CST or CSP, EVP, CMIT or CCM, EIT). PMP Certification. High level of computer expertise in multiple industry-wide software products, such as: MS Office Products Scheduling software such as Primavera and MS Project Client ERP systems such as JDE, QUAD, SAP, ARIBA, CONCUR PPM Software: Prolog, Proliance, Prism G2, Procore, Cleopatra, Cora Systems Context, Environment, & Safety A safety-minded individual who complies with the IPS Mission Zero Safety policy. Capable of working alone or as part of a team without a significant level of supervision. The employee is frequently required to stand, walk, and sit for long periods of time with extended computer use. Experience working in both a Home Office and a Field environment. Travel to client sites as needed. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
    $120k-150k yearly 4d ago
  • Laboratory Assistant Manager

    Affinity Health Partners LLC 4.7company rating

    Plymouth, NC job

    Job DescriptionDescription: The Laboratory Assistant Manager is responsible for the day-to-day operations of the laboratory, including staff supervision, assisting with budgeting, and placing orders for lab supplies. They develop and implement policies and procedures to ensure the safety of laboratory personnel and the quality of lab results. The Laboratory Assistant Manager also coordinates with other departments within the hospital or clinic to ensure smooth operation of the laboratory. ESSENTIAL JOB DUTIES: To oversee and manage all aspects of the laboratory, including personnel, equipment, and operations. To develop and implement policies and procedures to ensure the efficient and effective operation of the laboratory. To ensure that all laboratory personnel are properly trained and qualified to perform their duties. To maintain a safe and clean working environment in the laboratory. To monitor and control inventory levels of supplies and materials needed for the operation of the laboratory. To prepare reports on the activities of the laboratory as required by management or regulatory agencies. RESPONSIBILITIES/KNOWLEDGE/SKILLS: Supervise and coordinate the work of laboratory technicians and other staff. Plan and oversee the laboratory's budget, including purchases of equipment and supplies. Develop and implement policies and procedures for the operation of the laboratory. Ensure that the laboratory meets all applicable safety regulations. Keep abreast of new developments in the field of laboratory science and incorporate them into the lab's operations as appropriate. Train new employees in the use of lab equipment and procedures. Perform various tests and analyses using lab equipment, as needed. Prepare reports on the results of tests and analyses conducted in the laboratory Requirements: QUALIFICATIONS: High School Diploma Training in formally accredited Laboratory Science Program Previous job experiences as a MLT/MLS Must be eligible for certification PHYSICAL REQUIREMENTS: Frequent mobility and/or sitting required for extended periods of time Manual dexterity and use of a calculator or computer keyboard. Varied activities including standing, walking, reaching, bending, lifting Occasionally lifts to 25 pounds Requires corrected vision and hearing to normal ranges Requires working under stressful conditions or working irregular hours Exposure to communicable diseases, toxic substances, ionization radiation, medicinal preparations, and other conditions common to a hospital and/or clinic environment
    $43k-75k yearly est. 8d ago
  • Documentation Control Lead

    Pharmatek Consulting 4.0company rating

    New Brunswick, NJ job

    The Document Control/QA Specialist will be responsible for maintaining the lifecycle of validation documents within an automated system. This role involves performing quality reviews of validation protocols, ensuring compliance with internal and regulatory standards. Key Responsibilities: • Manage validation documentation in automated systems, including document control and archiving. • Perform quality reviews of IQ/OQ/PQ protocols, test scripts, and validation reports. • Collaborate with the CQV and engineering teams to ensure documentation aligns with project milestones. • Assist in audits and inspections by providing necessary documentation. • Ensure all document control activities comply with FDA, cGMP, and internal quality standards. Requirements Qualifications: • Bachelor's degree in Life Sciences, Engineering, or related field. • 8+ years of experience in document control and quality assurance in pharmaceutical settings. • Expertise in validation documentation management and quality review processes. • Strong understanding of regulatory requirements, including FDA and cGMP. • Excellent attention to detail and organizational skills. • TOP review and compilation
    $74k-105k yearly est. 60d+ ago
  • QC Technical Reviewer

    Aurobindo Pharma Ltd. 4.4company rating

    Aurobindo Pharma Ltd. job in Durham, NC

    Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in. Job Overview This position is responsible for the technical review of raw data, qualification protocols, Certificate of Analyses and other technical documents for the release of raw materials, finished products and stability monitoring. Functions will include supporting Laboratory investigations and writing technical reports for method transfers/verifications as it pertains to components, raw materials and finished pharmaceutical products. This positions supports ensuring compliance with standard operating procedure and all regulatory requirements that may arise. This position is responsible for providing training to department employees as required stemming from deviations and/or laboratory investigations. This position will also reponsible for anyother compliance task assigned by the department Head. Responsibilities * Technical review of raw data for the QC group * Technical review of method transfer/verification protocols * Technical writing of specification documents, standard test procedures, general test procedures, SOPs, qualification protocols * Review, manage, and monitor stability trend tables * Support investigations that arise in the QC testing of raw materials/finished products as needed * Work with all parties as applicable, technical services, material management, manufacturing, packaging, and the laboratory to identify the breadth and scope of the investigation to determine the appropriate root cause * Support the implementation of corrective actions, complete the trending analysis, and determine product disposition as applicable * This role will foster a collaborative relationship with manufacturing and laboratory personnel, focusing on high-quality, systematic investigations, meaningful corrective actions, and reducing the rate of deviation generation. Provide support to determine appropriate corrective actions to prevent the recurrence of the deviation * Track the effective measure of each implemented corrective action and take appropriate action if and when required * Provides oversight and final review of investigations to ensure adherence to cGMP, rigorous technical content, investigation clarity, and completeness Qualifications - Skills & Requirements * B.S/MS degree in engineering/Chemistry/Scientific field required * Minimum 3 years of experience in an analytical role, technical review role, or quality assurance role with an emphasis on raw data review within the pharmaceutical industry * Familiarity with Empower 3 data collection system * Working knowledge of cGMPs and regulatory requirements as they apply to pharmaceutical testing. * Familiarity with compendial methods (USP/NF, EP, JP, BP, etc.) * Experience in investigation/deviation management * Technical writing skills with experience related to both laboratory and manufacturing investigations Education & Experience * B.S/MS degree in engineering/Chemistry/Scientific field Required * Minimum 3 years experience in an analytical role, technical review role, or quality assurance role with an emphasis on raw data review within the pharmaceutical industry Physical Requirements OFFICE POSITION - While performing the duties of this job the employee is required to: • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment • Specific vision abilities required by this job include close vision requirements due to computer work • Light to moderate lifting is required • Moderate noise (i.e. business office with computers, phone, and printers, light traffic). • Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Additional Physical Requirements Job requires the use of his/her feet to operate foot controls or for repetitive movement Hand Manipulation is required - Fine Manipulation Left HandHand Manipulation is required - Fine Manipulation Right HandHand Manipulation is required - Simple Grasping Left HandLifting 8+ Hours - 0-10 PoundsHand Manipulation is required - Simple Grasping Right HandBending 1-4 HoursClimbing 1-4 HoursKneeling 1-4 HoursTwisting 1-4 HoursWalking 1-4 HoursSitting 5-8 Hours Blood/Fluid Exposure Risk Category II: Usual tasks do not involve exposure to blood, body fluid, or tissues but job may require performing unplanned Category I tasks.
    $45k-60k yearly est. Auto-Apply 26d ago
  • Epidemiologist

    Mitsubishi Tanabe Pharma 4.1company rating

    Jersey City, NJ job

    Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Job Description Develop initial or update safety signal detection and management documents for global developmental and marketed products to support and enhance appropriate signal detection activities and robust safety evaluation Review and/or develop relevant epidemiology sections and/or papers for relevant conferences and/or peer-reviewed journals as assigned Develop or support development of instruments for epidemiological assessment strategies and safety surveillance in coordination with Biostatistics Participate in plan/design, execute or contribute to development of observational studies and interventional studies for assigned global developmental and marketed products Develop epidemiological assessment and safety surveillance plan for assigned projects or studies Review epidemiology data in supporting the development of risk management plan/risk evaluation and mitigation strategies (REMS) and other safety related documents Contribute to the design, implementation, and management of safety studies and clinical trials Search and review epidemiological data and safety literature in supporting development of Ad hoc or regular safety submissions Accountable for epidemiology sections of investigator's brochures, risk management plans, aggregate safety reports (DSUR and PSUR), and responses to health agency's inquiries for global development and post-marketing products Perform safety data evaluation and risk assessment for assigned drug products Provide or contribute to the materials used for Safety meetings including but not limited to the Clinical Safety Team, Data Monitoring Committee, Global Safety Data Monitoring Committee, Data and Safety Monitoring Board (DSMB) Contribute epidemiology input to GST Working Group meetings, Signal Detection meetings and other Global Drug Safety and Evaluation Center (GDSEC) meetings as assigned Performs other departmental duties as assigned Qualifications Education: Graduate degree (PhD, MD, MS, MPH) in a relevant field is required: Doctoral degree with at least 2 years of industry experience, academia, and/or regulatory agency Master's degree with 6+ years of experience in a national/local public health agency, regulatory agency, biopharma, and/or the medical device industry (including at least 1 to 2 years of biopharma or medical device industry experience) Professional Experience: Experience and training in public health, pharmacy, health services research, health outcomes research, epidemiology, biostatistics or other relevant fields Familiarity and experience with the development and implementation of epidemiology research strategies Expertise in Biostatistics, Epidemiology/ secondary database analyses (e.g., claims, national survey data, etc.), Psychometrics Demonstrated experience as a member of a product or project team Experience in scientific writing of peer-reviewed, academic and/or public health literature Familiarity with Drug Development and Phase 1-4 clinical trials Knowledge and Skills: Strong understanding of research methodology and statistics, as well as strong technical writing, and strong ability to critically review published scientific literature Strong verbal and written communication, presentation skills, including experience Critical thinking and problem-solving skills, ability to set priorities and develop strategies/studies to answer complex research questions Experience managing multiple projects, often complex in nature and with both internal and external stakeholders under short timelines Ability to analyze and interpret safety data Good understanding of advanced design and analysis techniques used in the analysis of secondary data (e.g., matching, multivariate regression, meta-analysis, etc.) Ability to conceptualize the presentation of results (e.g., develop layout of tables and figures for inclusion in analysis plans) Working knowledge of 2 or more secondary database types (e.g., claims, surveys, electronic medical records) Working knowledge/ability to use standard statistical packages (i.e. SAS, STATA, etc) Ability to contribute to written processes to ensure consistent and quality deliverables Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:
    $51k-113k yearly est. Auto-Apply 60d+ ago

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