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Noven jobs - 37 jobs

  • Mfg Operator PC - TEMP

    Noven Pharmaceuticals 4.6company rating

    Noven Pharmaceuticals job in Miami, FL

    Responsible for overall activities related to manufacturing and packaging of potential and existing products. Operate and maintain small production equipment. Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities. Maintain records and cleanliness in compliance with cGMP, SOP, and Safety protocols. Responsibilities Process products in strict compliance with cGMP and SOPs. Operate and maintain production equipment. Participate in all production activities, including manufacturing, packaging, punching, and pouching of products. Clean equipment and manufacturing room in compliance with established policies and regulatory requirements. Set up equipment for operation, labeling, patch and pouch inspection, and special packaging clinical studies. Assist with shipping, receiving and warehousing. Perform related duties and special projects as assigned. Qualifications Competencies: Education / Experience: High school diploma or technical training. At least two years of professional experience with knowledge of manufacturing process is required as related to the pharmaceutical industry. In lieu of that, at least 1-3 years of working experience in another industry with demonstrated ability to learn new processes and procedures quickly. Good communication skills. Highly organized operator is essential with strong attention to detail as well. Judgment / Decision Making: Duties performed are of a routine order within established practices. Some minor decisions and judgment within established precedent is required Work Environment: Production environment with exposure to airborne particles, moving parts, and odors. Carelessness could result in minor injury. Physical Demands: Majority of time spent standing, stooping and bending. Regularly required to lift and carry objects weighing up to fifty pounds. Visual acuity and manual dexterity required to operate machinery as necessary.
    $21k-27k yearly est. Auto-Apply 8d ago
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  • Calibration Technician

    Noven Pharmaceuticals 4.6company rating

    Noven Pharmaceuticals job in Miami, FL

    Overview Seeking Metrology/Calibration Technician (entry level) to calibrate and repair test instruments in accordance with precision standards and procedures. The ideal applicant is familiar with various test and measurement processes, self-motivated, a team player, and has a strong commitment to continuous improvement. Responsibilities Perform calibration, testing, troubleshooting, and repairs on a wide range of measuring and test equipment. Complete required documentation to certify the verification and calibration of measuring and test equipment. Set up standard and special purpose laboratory equipment to test, evaluate, and calibrate other instruments and test equipment. Manage time to achieve maximum efficiency. Perform routine equipment maintenance. Calibrate equipment to industry standards. Troubleshoot equipment failures. Conduct equipment repairs. Respond to departmental queries. Suggest equipment upgrades. Maintain calibration equipment and supplies. Work with outside vendors to accomplish calibration/maintenance tasks. Other duties as directed by supervisor Qualifications Competencies Education / Experience: High school diploma 1+ years of instrumentation experience preferred. Experience in various fields of calibration, preferably pharmaceutical. Knowledgeable in cGMP requirements. Ability to identify resources when necessary. Must be computer literate with knowledge of office application software (Microsoft Word, Excel, PowerPoint, ACCESS, and Outlook). Excellent communication skills, both written and verbal Judgment / Decision Making: Under general supervision, exercises some judgement in accordance with well-defined policies, procedures and techniques. Moderately complex work performed within established practices and procedures requiring original thinking. Effectively identifies problems as they occur and takes appropriate steps to solve straight-forward problems. Works on assignments that may be complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations. May determine methods and procedures on new assignments and may provide guidance to other non-exempt personnel Work Environment: While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts. The noise level in the work environment is usually moderate. May be required to work in areas where high noise hazards prevail. May be exposed to fumes or airborne particles. Physical Demands: Often required to stand for up to an hour at a time with stooping and bending. Required to walk, sit, and use fingers and hands, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. Must lift and/or move up to 50 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception
    $41k-60k yearly est. Auto-Apply 8d ago
  • Oncology Territory Manager, Breast - Orlando

    Daiichi Sankyo 4.8company rating

    Orlando, FL job

    At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product, and its approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. Responsibilities * Represents the assigned products to health care professionals in assigned sales territory. * Achieves or exceeds sales objectives through promotion of the assigned product features and benefits to assigned customers. * Develop and execute comprehensive business plans. * Applying knowledge of the healthcare industry, trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmacy economics, payer reimbursement landscape, and patient flow/influence between academic institutions, hospitals, and community practices). * Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient treatment. * Analyze customer needs and interests, territory performance, program outcomes, and business trends; develop and execute business plans that optimize the commercial potential of our products. * Maintain expert understanding of the relevant disease state(s), assigned Daiichi Sankyo brands, and competitor products. * Completes all assigned training. * Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts. * Communicates on a regular basis with District Manager, internal and co-promote peers and discuss issues and opportunities. * Builds relationships with Daiichi Sankyo customer base and key opinion leaders. Communicates products approved indications, features and benefits in both individual and group settings. * Meet all administrative expectations and standards, including budgets, reporting, and communication. * Maintains a current key customer target list, submits regular updates to the customer database and plans calls to meet goals. * Reviews territorial reports with District Manager and learns how to use reports and databases as instruments to achieve assigned goals. * Submits completed reports on-time and communicates matters that are relevant to the marketplace to the District Manager. * Maintains all equipment and territorial records in the prescribed manner. * Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management. * Adhere to compliance and operating principles and expectations. Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): * Bachelor's Degree required Experience Qualifications: * 4 or More Years of sales/marketing experience in the pharmaceutical or medical industry required * 4 or More Years of oncology therapeutic experience strongly preferred * 1 or More Years additional therapeutic experience in diverse roles - training, marketing, market access preferred * Oncology product launch experience preferred * Copromotion experience a plus * Strong verbal and written communications skills * Proficiency in MS Word, Excel, PowerPoint and Outlook Additional Qualifications: * Must be able to travel approximately 40% to 60% * Must have a valid driver's license with a driving record that meets company Compensation and seniority level/title based on experience and qualifications Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: USD$139,440.00 - USD$209,160.00 Download Our Benefits Summary PDF
    $45k-109k yearly est. 6d ago
  • Thoracic Oncology Sales Consultant Sr - Miami/Puerto Rico

    Boehringer Ingelheim Group 4.6company rating

    Miami, FL job

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Sr. Oncology Sales Consultant (Sr. OSC) is responsible for implementing the BIPI Oncology sales and marketing plans to assure maximum distribution and market penetration of BIPI Oncology products within BIPI guidelines, policies, and directives. They are proactive in their approach and response to situational business needs and requirements. The Sr. OSC will conduct their business with Oncology Accounts and Oncologists and related oncology health care specialists. The incumbent will have additional responsibilities for sales activities, strategic account planning and execution in academic and community centers, integrated delivery networks, community-based practices, managed care networks and other organized customers as defined by the business need within the region. * Travel to PR expected every 4 to 6 week * Bilingual - English / Spanish Duties & Responsibilities LEADERSHIP The Senior Oncology Sales Consultant is responsible for implementing BIPI Oncology sales and marketing plans to ensure maximum distribution and market penetration of BIPI Oncology products within BIPI guidelines, policies, and directives. They are proactive in their approach and response to situational business needs and requirements. The Sr. OSC will conduct their business with Key Oncology Accounts, Oncologists, and related oncology health care professionals. The incumbent will have additional responsibilities for sales activities and initiatives that have regional and national impact, working with academic and community centers. As a Sr. OSC, the incumbent will be recognized and respected as a regional team leader with additional responsibilities and strategic projects, support in the development of peers (i.e., Mentor projects), special assignments around training (i.e., reimbursement marketplace, managed care strategies, customer development, selling skills, territory analysis and management, regional point for regional analysis etc.), support and pull through, Key Opinion Leader identification and development, and national level projects (i.e. leading national oncology conventions, training at national meetings, participating in brand strategic planning, and an active contributor to national sales advisory boards, etc.). CLINICAL EXPERTISE The Sr. Oncology Sales Consultant is the role model of exceptional knowledge of BIPI Oncology products, marketplace knowledge, and can utilize and translate product knowledge into effective sales presentations that provide customer focused solutions. As a trusted oncology consultant, he/ she is valued by their customers as a partner who executes brand strategies to support appropriate patient identification and consistent company sales. OSCs provide an expert understanding of the oncology landscape, they encourage and receive requests for expert technical information during and outside standard meetings, communicate and collaborate with internal functions. The Sr. OSC is up to date on newly emerging data, opinions of KEEs, and can support colleague learning during internal meetings and training. STRATEGIC ACCOUNT PLANNING AND VALUE BASED SELLING The Sr. Oncology Sales Consultant develops and leads strategic account plans to support Oncology Health Care Professionals and Oncology Account needs. These strategic account plans provide an opportunity to deeply explore customer opportunities and solutions through an understanding of our account backgrounds. Determining key relationships, key stakeholders, account past proven value and developing short-term and long-term activities to improve relationships and account growth. The Sr. Oncology Sales Consultant enables valued based discussions with HCPs and staff to support understanding needs, opportunities, and problem solving. The consultant fosters Oncology HCP network development and communication, has accurate and timely follow-up discussions to advance relationships with Oncology HCPs. The consultant excels at using appropriate BIPI approaches which support and encourage technical exchange of scientific knowledge and dialogue, thereby providing enhanced value to the HCP through facilitation of individual patient management and therapy decision making process. Requirements Bachelor's degree required; MBA (Master of Business Administration) preferred. 7 or more years of successful US pharmaceutical sales experience (primary care, specialty care, institutional) with a minimum of 3 years in Oncology Sales required. • Strategic Account Management skills with history of engaging with and driving engagement with complex customer types. Successful launch experience preferred Experience in rare disease markets preferred Strong communications skills are required to perform the job satisfactorily. Requires at least 1-year prior experience demonstrating account management, leveraging HUB services, collaborating with specialty pharmacies, supporting reimbursement navigation, fostering market development, regional Key External Expert (KEE) engagement & relationship management, linking KEEs with appropriate internal stakeholders, fluency in the inner networking & navigation of multiple customer types. Strong ability to engage customers using company provided virtual platforms. Ability to translate key scientific information supporting product, competitors, science, and marketplace to a broad range of Oncology customers. Ability to travel (25%) with overnights and attendance at some weekend programs. Self-directed work environment with day-to-day operations and decisions. Develop and maintain working relationships with Oncologist and all other Oncology health care providers. Must Possess ability to communicate effectively and consistently a dialogue rich in Oncology science, knowledge, and marketplace with broad range of Oncology customers. Must remain current with all evolving changes in the Oncology marketplace while maintaining an in-depth knowledge of the Oncology science and competitive therapies and clinical pathways. Masters and applies clinical Oncology reprint content for effective knowledge, dialogue, and application with Oncology customers. Valid Driver's License and acceptable driving record Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Desired Skills, Experience and Abilities BUSINESS ACUMENT AND CROSS FUNCTIONAL COLLABORATION The Sr. Oncology Sales Consultant provides expert identification of key territory business needs and opportunities, establishes strategic business plans that address comprehensive territory business needs and identifies/supports regional business needs through active involvement of Direct Manager, Oncology Marketing Team, Regional Marketing, National and Strategic Accounts, and other BI internal functions and personnel in the development, leadership and accomplishment of key territory business opportunities. The Sr. Oncology Sales Consultant consistently monitors and updates local plans to optimize key territory opportunities. The Sr. Sales Consultant manages their territory budget and supports the development of territory and regional champions, regional and national KEEs, and advocates to support BIPI Oncology products. EXECUTION AND ADMINISTRATION Provides expert analysis of territory information to optimize Oncology HCP calls. Monitors and effectively reacts to local market conditions for changes that impact business at territory level. Utilizes Octopda, VEEVA, Multi-channel Engagement (MCE)and all resources to exceed execution goals, monitors progress, adjusts where required. Completes all administrative responsibilities as required and/ or directed by management. Demonstrates regional leadership through successful and timely completion of all training in advance of due dates in our internal systems. STRATEGIC ACCOUNT MANAGEMENT EXCELLENCE Demonstrates complete and exceptional knowledge of BIPI Oncology accounts and related marketplace influences, effective translation of account-based knowledge into account profiling and execution. The Sr. OSC is customer focused with a priority directed towards providing solutions-based customer options. Delivers exemplary level of clinical and technical value to his/her customers, assisting the health care customer in meeting their unique patient care needs, all within BI regulatory guidelines. Provides expert understanding of the Oncology Payer landscape. As a trusted Oncology consultant, encourages and receives requests from customers for expert technical information outside of standard visits. Through all these endeavors, develops trust and subsequent value with Oncology customers. UNDERSTANDING PATIENT JOURNEY The Sr. OSC will demonstrate deep knowledge of the market, understand market dynamics that influence the referral processes, patient identification, key stakeholders, and all involved in delivering Oncology recommended treatments.
    $94k-127k yearly est. 60d+ ago
  • SR AD, Clinic Excellence - South/West U.S.

    Boehringer Ingelheim 4.6company rating

    Orlando, FL job

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Associate Director, Clinic Excellence is the strategic leader of Clinic Excellence Consultants (CEC's) within an assigned geography. This role is responsible for leading and motivating CEC's to create clinic business plans, generate sales, grow market share and profitability and drive clinic loyalty. The position holder works collaboratively with their assigned district managers to ensure the Clinic Excellence team is effectively communicating and working cooperatively across the wider sales team. This includes the development of the regional level business plan and implementation of the sales/marketing plan to assure optimal market penetration of promoted products within company guidelines, policies, and directives. The SR AD, Clinic Excellence must possess an in-depth working knowledge of markets across their geography, commercial gen vet accounts, corporate accounts, and retail. The incumbent will continuously maximize the use of key company resources and budgets to exceed sales targets and appropriately position BI. This role ensures equal and consistent application of established policies and procedures in the management of employees to meet or exceed sales goals. The position holder is expected to lead their team to deliver excellence in customer value creation and ensure above market growth. This role is r responsible for implementing the Clinic Excellence growth strategy and defining the short, medium and long term growth tactics for the team through insights and opportunities based on monthly performance analysis and relationships. **Duties & Responsibilities** Clinic Excellence Strategic Plan Development and Execution: + In collaboration with leadership, defines the US Clinic Excellence strategy, goals, and solutions to ensure mutual value between the clinics and Boehringer along with optimal clinic intimacy and long-term loyalty to Boehringer. + Leads and monitors dedicated CEC team activation to ensure excellence in action plans and execution. + Analyzes and evaluates the characteristics of the continually changing and complex markets and clinics in the assigned area. + Ensures strong internal and external collaboration across the full Boehringer Pet Vet field team, cross functional team members and key clinic team members. + Regularly monitors and updates the financial potential, targets, trends and share of customer spend to support long range planning and annual budget exercises. Clinic Excellence Account Performance: + Ensures performance meets or exceeds annual Company sales, contract performance goals and market share objectives. + Establishes a plan for using all allocated resources to accomplish the sales and planned objectives of the CEC team within the budget. + Responsible for analyzing, evaluating, and interpreting formal and informal reports to determine if resources are being used effectively to increase operating results as well as re-directing resources to maximize sales as business conditions warrant. + Ensures agreements are upheld to deliver optimal Boehringer financial performance and drive desired behaviors. + Ensures that appropriate resources from the various business areas are engaged. Guides and controls investment in all activity in the assigned clinics. + Implements appropriate Boehringer supported tools to maximize return on investment in the clinics driving loyalty to Boehringer. + Ensures CEC team utilizes CRM tools to create pre-call plans and keep up to date account records. + Ensures CEC team uses appropriate Boehringer sales training techniques to facilitate business. Clinic Excellence Opportunity Identification: + Leads the CEC's to analyze all available data, including but not limited to sales, gross to net and market share data, to identify clinics of strategic importance to Boehringer. + Works in collaboration with district managers, sales representatives & CEC's to prioritize key clinics to pursue and close sales and loyalty opportunities through the successful execution of the clinic business plan. + Regularly reviews data analytics to ensure the CEC's are calling on the correct accounts and actions clinic and personnel changes as appropriate based on analysis. Leading and Coaching of Clinic Excellence Team: + Directly leads, coaches, and develops a dedicated team of CEC's. + Monitors team members' performance including the development of actionable MAG plans, provides regular feedback, and conducts timely MAG Plan reviews. + Contributes to the development of others to enhance the capabilities of the Pet Vet Sales organization ahead of the changing market demands. + Oversees the recruitment, selection, and development of top-tier talent. + Ensures development of team members by setting goals, providing training opportunities, coaching and quarterly performance evaluations while traveling with the CEC's. + Recommends merit increases and promotion of CEC team members as appropriate. **Requirements** + BS/BA degree required. + MBA, Veterinary, Animal Science or comparative degree preferred. + Minimum of ten to twelve (10-12) years of relevant sales/account management/business operations experience with a minimum of five (five) years in animal health or a related industry. + Two to five (2-5) years' experience leading teams in sales, marketing, or account management. + Must possess strong leadership and coaching skills to maximize performance results. + Must demonstrate an aptitude and desire to sell and gain market share. + Knowledge of the Animal Health/Veterinary Clinic Industry economics and drivers preferred. + Ability to work and thrive in a matrix team environment. + Excellent communication, negotiation, and presentation skills (verbal and written). + Excellent interpersonal and communication skills. + Ability to lead without authority and inspire a team to follow. + Strong learning agility. + Demonstrated high level of business and financial acumen. + Proficiency in various business software applications. + Ability to travel (up to 40% overnight travel domestically). + Valid driver's license and an acceptable driving record. + Authorization and ability to drive a company leased vehicle or authorized rental car. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Additional Duties & Responsibilities** Teamwork, Collaboration and Communication: + Develops and nurtures key contacts with internal and external stakeholders that will have a positive impact on operating results. + Responsible for developing networks, driving execution improvement, exploring innovative solutions, and building productive and mutually beneficial relationships. + Maintains accurate, concise, and timely communications with CEC's, assigned district managers, wider Pet team and cross functional partners. + Leads team meetings and communicate regularly with sales leadership to ensure collaboration. Competitive Intelligence, Market & Industry Knowledge: + Educates team on market, customer, and industry information to drive higher quality CEC plans and customer interactions. + Monitors market conditions for changes that impact the animal health business and updates team to ensure changes are incorporated into CEC business plans. + Continuously gathers knowledge of competitors share with CEC's so that they can effectively position Boehringer's solutions against them. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $91k-115k yearly est. 4d ago
  • SR Specialist EHS

    Boehringer Ingelheim 4.6company rating

    Gainesville, FL job

    The EHS and Compliance senior Specialist will lead and execute the Environmental, Health and Work Safety programs for the Gainesville, GA location in close coordination with North America EHS. The position will support reporting to OSHA, EPA, GA DEP, GA DOL/DOH, DOT as well as corporate reporting requirements. In addition, the position will support new initiatives related to the new chemical entities as part of the drug discovery efforts. The person will be involved in supporting key compliance initiatives on site. Key responsibilities include creation/revision for EHS programs, ensuring the EHS Management System is in place with appropriate EHS support for Gainesville to assure compliance with company and legal requirements; achieving continuous improvement in health, safety and environmental performance. Lead the implementation and maintenance of comprehensive risk identification and management processes for Gainesville activities. Ensure processes are in place for communicating risks to the business unit management and stakeholders (risk map). Work with functional management to develop and track EHS performance improvement plans based on risks. Support the site emergency response teams to ensure a good quality emergency and crisis management system for the site. Major responsibilities include: Establishment/maintenance of chemical inventory or appropriate company system Maintain Safety Data Sheet master file. Revise facility-wide HSE programs. Maintain job safety analysis documents. Conduct new employee safety orientation on a regular basis. Maintain EHS training records working with Learning One Source (LOS) coordinators. Coordinate EHS training for scientific staff, for example respirator users, hearing protection and powered industrial trucks. Assist with review of Standard Operating Procedures focusing on safety and environmental areas. Participate in EHS Committee activities. Assist with building tours focusing on HSE needs. Support Quality and Safety objectives. Maintain a good and safe working environment. Assisting and supporting the OH program, IH program and accident/incident investigations Lab and office ergonomics. Key compliance initiatives on site. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities Participate as an active member of the Site Operations team, ensuring achievement of overall Site Operations goals. Responsible for pro-actively providing the Head of Site Operations with regular updates regarding the level of EHS compliance with company procedures and processes. Responsible for day-to-day coordination of EHS programs and environmental compliance, including but not limited to contractor safety program, LOTO, JSAs, EHS training, emergency response, fire safety program, hearing conservation program, and ergonomic program for Gainesville site. Complete all required record keeping/reporting related to OSHA, EPA, GA DEP, GA DOL/DOH/DOT, as well as Corporate EHS reports. Develop and implement internal audit programs to ensure that the staff and the site are fully compliant with regulations and with internal policies. Identify areas of noncompliance and work with individual functional groups to resolve. Serves as the Chair of the HSE Committee. Serve as member of Crisis Management team in appropriate role as determined by Head Site Operations. Participation in exposure level discussions and implementation of assigned tasks based on need. Responsible for the implementation of the support in key compliance initiatives on site. Requirements Bachelor's chemistry/scientific or engineering degree from an accredited institution with at least three (3) years of demonstrated EHS knowledge/experience. Strong working knowledge of laboratory operations within the chemical/pharmaceutical industry. Must be able to deal with routine and emergency situations in a reliable and professional manner. Must be able to communicate with all levels of local management and staff as well as a variety of government agencies. A good team player and team leader. Strong interpersonal skills and communication skills. Ability to handle multiple projects simultaneously and implement projects based on overall priorities. Ability to work through conflicts in a professional manner and seek assistance as needed in difficult issues. Decision making skills required within areas of responsibility. Transparent in communication of failures. Positive attitude and willingness to take appropriate risks. Ability to challenge teams and functional heads and recommend innovative alternatives related to EHS processes.
    $103k-133k yearly est. 3d ago
  • Medical Science Liaison/AD Medical Science Liaison (Obesity/Liver Health) Florida

    Boehringer Ingelheim 4.6company rating

    Jacksonville, FL job

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Medical Science Liason is part of a regional therapeutic area MSL team within Field Based Medicine (FBM), who reports into the MSL Sr AD. The focus of this role is field based scientific exchange (SE), for which the MSL will leverage their scientific background, industry knowledge, and business acumen to act as a scientific resource to scientific experts (SCEs), while gathering insights that inform Scientific Objectives (SOs) and strategic decision making by Medicine. Within their territory, MSLs are responsible for establishing, cultivating, and maintaining relationships with SCEs. Further, the MSL functions as an extension of the medical information group to provide product and pipeline therapeutic area expertise to SCEs and HCPs, and as a scientific expert to internal stakeholders within Medicine and Commercial groups at BIPI. The MSL is a collaborative member of BIPI, who is expected to communicate seamlessly with other members of the field-based organization and perform all activities in a compliant manner. **Duties & Responsibilities** Customer Interactions and Scientific Exchange: The overarching objective of the MSL is to be in the field conducting scientific exchange with prioritized SCEs. Therefore, the principal effort of the MSL will be focused on planning, preparing for, and conducting field-based interactions and scientific exchange in support of the TA Scientific Objectives (SOs). Specific aspects of the role include, but may not be limited to: + Proactively conducting scientific exchange with SCEs to support the SOs. + Establishing and maintaining scientific relationships with SCEs, while developing a strong understanding of territory specific healthcare systems and clinical practices related to patient care, disease management, treatment protocols, and research interests. + Acting as a scientific resource to SCEs and HCPs to reactively answer specific questions on TA or disease state topics and BI compounds through scientific exchange. + Providing disease state education on topics related to TA Scientific Objectives. + Acting as a scientific resource to Scientific Experts at payer accounts and integrated delivery networks when requested. Planning and Support: Develop a tactical customer-centric medical engagement plan for their geography in alignment with management and provide internal and external scientific support - as required. Specific aspects of the role include, but may not be limited to: + Proactively developing a territory specific medical engagement plan for scientific exchange with prioritized SCEs, which supports the TA Scientific Objectives (SOs) and priorities. + Proactively assessing SCEs that are appropriate to interact with as part of the medical engagement plan. + Identifying and communicating challenging gaps between BIPI and customer expectations, needs, and priorities. + Proactively monitoring and adjusting tactical medical engagement plan to better achieve TA Scientific Objectives. + Supporting identification and assist with development of scientific materials, as directed, required to effectively conduct scientific exchange. + Supporting identification of training needs to effectively engage in scientific exchange. + Maintaining regular communication (field based, virtual meetings, etc.) with the TA MSL Team, to review ongoing activities and insights, share best practices, and communicate learnings. + In alignment with Clinical Operations, interacting with current and potential BI study investigators to support clinical trial activities. + Facilitating logistical communications between BIPI and HCPs regarding Investigator Initiated Studies (IIS), External Collaborative Research, company study contracts, etc., as requested. + Providing additional scientific support for Medicine and Scientific Affairs activities in alignment with the local working instruction, which may include but are not limited to support for scientific congresses and medical information. + Maintaining clinical, scientific, and technical expertise in specific TA through continuous learning and knowledge of the TA related scientific literature. **Requirements** **MSL Education and Experience Requirements:** + BSc required plus one of the following:o Advanced science/clinical degree (PharmD, M.D., DO, Ph.D.) with 1+ years' relevant experience (preferred), OR o Masters in health sciences with 3+ years' of clinical or therapeutic area experience, OR o BSc. with MBA or BSN with MBA and 5+ years' of clinical or therapeutic area experience, OR o PA with 3+ years' of clinical or therapeutic area experience ORo Other medical licensure (Rph, RRT) with 7+ years of experience. + 2+ years' MSL experience - preferred. **Associate Director, MSL Education and Experience Requirements:** + BSc required plus one of the following:o Advanced science/clinical degree (PharmD, M.D., DO, Ph.D) with 3+ years' relevant experience (preferred), OR o Masters in health sciences with 5+ years' of clinical or therapeutic area experience, OR o BSc. with MBA or BSN with MBA, and 7+ years' of clinical or therapeutic area experience, OR o PA with 5+ years' of clinical or therapeutic area experience.o Other medical licensure (Rph, RRT) with 9+ years of experience. + 2+ years' MSL experience required, 4+ years preferred. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Compensation Data** This position offers a base salary typically between $140,000 and $269,000. For an overview of our benefits please click here. (***************************************************************** **Additional Duties & Responsibilities** : Insight Generation and Reporting: Identify, document, discuss, and communicate scientific insights as guided by the TA Scientific Objectives. Specific aspects include, but may not be limited to: + Documenting field generated scientific insights within appropriate system(s), and communicate to appropriate internal stakeholders, as required. + Participating in the discussion of scientific insights gathered by the TA MSL team, to understand the breadth of insights, potential impact, and to stimulate scientific exploration, as directed by management. + Supporting communication of scientific insights across the Medical and Commercial organizations, as directed by management. + Identifying changes in the healthcare landscape and trends impacting delivery within the territory (i.e., new stakeholders impacting the delivery of or access to care). Collaboration: The MSL collaborates with the field-based medicine team, CDMA, appropriate Commercial personnel, and the broader organization - in a seamless and efficient manner. Specific aspects include, but may not be limited to: + Collaborating within the TA MSL Team on all aspects of planning, execution, sharing of best practices, and insight generation related discussion to understand the breadth of insights, potential impact, and to stimulate scientific exploration. + Collaborating to provide field based scientific expertise for key accounts, as required. + Learning about new and evolving customers and the changing medical needs of such customers. + Collaborating with Commercial personnel, as appropriate and in a compliant manner, to provide scientific support for internal and external activities where there is a defined and appropriate scientific role for FBM. + Collaborating with CDMA and the broader Medicine organization, to provide scientific support and communicate scientific insights. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $140k-269k yearly 14d ago
  • QC Document Reviewer

    Noven Pharmaceuticals 4.6company rating

    Noven Pharmaceuticals job in Miami, FL

    The QC Document Reviewer is responsible for auditing all data in LIMS, Empower, laboratory worksheets, Laboratory notebooks, calibration protocols/reports and raw data archives to ensure the validity and accuracy of the data for finished product, intermedia, raw materials, components. Responsibilities This individual will be responsible for carrying out sample analysis and data processing within stated timeframes and in accordance with Standard Operation Procedures (SOPs) and Company Policies. Perform detailed data review of test results from HPLC, GC, IC assays for compliance with GLP and internal SOPs to support laboratory operation. Review lab equipment calibration records, logbooks, and other review functions as needed. Compile and maintain review records in accordance with SOP's and QC best practices. Work with analysts to complete any corrections to data notebooks, LIMS, Empower, etc. Communicate and respond to inquiries from internal departments regarding the status of results. Prepare and review forms and SOPs as needed. May be required to assist in training personnel in review procedures. Assist in preparing internal departmental documents such as SOPs, training documents, methods, and study plans. Must always comply with the Laboratory Safety Policy. Qualifications Minimum of four years of experience with a bachelor's degree in chemistry or related scientific field required. Alternately, three to six years of experience with a master's degree in chemistry or related scientific field. Alternately, zero to three years of experience with a PhD in chemistry or related scientific field -Required. Broad knowledge of scientific principles, methods, chromatographic analysis, analytical methods (i.e. HPLC, GC, Dissolution) and a good understanding of separation theories -Required. Candidate must have broad knowledge in all types of compendia testing (USP, EP, JP, BP) and wet chemistry techniques-Required. Good written English and verbal communication skills-Required. Must be highly organized and able to work under pressure. Must have strong interpersonal and leadership skills. Must be computer literate with knowledge in all Microsoft business applications. Strong background in scientific software such as Waters Corp. Empower and LIMS is a plus. Knowledge of GLP. Ability to multi-task and participate in multiple studies concurrently. Ability to produce high quality data while working under the pressure of strict deadlines. Work may require the use of PPE (personal protective equipment). Judgment / Decision Making: Duties are performed under general direction toward broad assignments with periodic reviews. Duties are performed within the framework of departmental or functional guidelines, requiring interpretation and original thinking. Work Environment: An office environment but on occasions could be work in a laboratory environment with exposure to chemicals, caustics, fumes, heat, and electrical current. Physical Demands: Visual acuity and manual dexterity required to operate computer, analytical instrumentation, sample preparation and proofread documents. The majority of time spent sitting and walking. Often required to lift objects weighing up to 20 pounds.
    $43k-85k yearly est. Auto-Apply 8d ago
  • Sr./System Account Executive - Orlando Health/Cleveland Clinic/Trinity

    Boehringer Ingelheim 4.6company rating

    Orlando, FL job

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunities for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The System Account Executive (SAE) is a specialist role responsible for pull-through of the account plan (developed by the Account Manager) at the Health System's various sites of care and with the Health Systems affiliated Health Care Professionals (HCPs). The SAE is also responsible for the delivery of brand value propositions to affiliated HCPs and generating advocacy for BI products with key decision makers in the system and delivering brand sales growth with the targeted HCPs and accounts. **Duties & Responsibilities** + Increase sales: Generates advocacy with key experts in high control priority health systems. Utilizes clinical and product knowledge, consultative selling skills, and the assigned Health Systems' business model, objectives, and patient flow in order to support the use of BIPI promoted products. + In addition, the SAE will seek to appropriately increase recognition, diagnosis and treatment rates within BIPI marketed disease state. Establishes and maintains communication/collaboration/coordination with co-promotion partners and BIPI employees. + Account Plan Pull-Through: SAE will be responsible for contributing to the development of the Account Plan, understand and pull through the Account Plan along with the Health System Marketing strategies. Delivers value to customers using insight, business analysis, problem solving and flexibility with a focus on opportunities, threats, and trends. Provides appropriate disease state and other relevant approved presentations to Health System staff as well as other qualified medical personnel as determined by account plans. + The SAE has accurate and timely follow-up discussion with key internal account team members and external stakeholders. Uses approved account management techniques to facilitate the decision-making process and engagement. + Supports the Health Systems' Triple Aim efforts in various care settings to include appropriate pull through of protocols, pathways, order sets, formularies, treatment algorithms, transition of care, and population health management initiatives to assist the Health System with the delivery of optimal care. + Aware of top plans for the priority Health System and key stakeholders. Engages the appropriate key stakeholders in discussions on the payer environment, copays, and formulary access. Supports products on Payor formularies. Works in concert with an extended team to pull-through MCO decisions. + Analyzes territory information to optimize Health System and key stakeholder interactions. Is knowledgeable of barriers and opportunities that impact business and promptly informs account team of any developments. Is aware of opportunities that meet both Health System needs as well as account plans and brand tactics. Utilizes CRM and supporting analysis of account plans to guide interactions and monitor appropriate Value Proposition use. Successfully completes all Sales Training requirements. + In conjunction with other field sales teams, assists in identification of thought leaders, innovators and advocates within the priority Health System. Manages programs, initiatives and budgets to stay within standards. Builds networks among advocates and key stakeholders within the Health System. + Performs all Company business in accordance with all regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community. **Requirements** **_This is a dual-level posting. Candidates will be hired at the level commensurate with their experience and business need._** **System Account Executive Requirements** + Bachelor's degree from an accredited institution required. Master's degree from an accredited institution preferred. + A minimum of four (4) years successful pharmaceutical sales experience, or equivalent. + A minimum of two (2) years successful account management experience preferred. + Successful sales performance history. + Ability to travel up to 75% depending upon geography. + Knowledge across portfolio is preferred. + Strong understanding of managed care and its impact on the industry. + Excellent judgment and problem-solving skills. + Ability to foster ongoing interactions and partnerships with targeted Organized Customer Stakeholders in the execution of account plans. + Demonstrates acceptable level of performance in current role. + Proficiency in Excel, Word, Outlook, and database applications. + Ability to travel (may include overnight travel). + Should reside in territory geography or be willing to relocate. + Valid Driver's License and an acceptable driving record. + Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. + Strong understanding of managed care environment and intricacies of health systems of varying size, control and willingness to partner. + Previous account management experience. + Various regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. **Sr. System Account Executive Requirements** + Bachelor's degree from an accredited institution required. Master's degree from an accredited institution preferred. + A minimum of seven (7) years successful pharmaceutical sales experience, or equivalent. + At least three (3) years of experience in the relevant accounts within the territory is preferred. + Successful sales performance history. + Ability to travel up to 75% depending upon geography. + Knowledge across portfolio is preferred. + Strong understanding of managed care and its impact on the industry. + Excellent judgment and problem-solving skills. + Ability to foster ongoing interactions and partnerships with targeted Organized Customer Stakeholders in the execution of account plans. + Demonstrates acceptable level of performance in current role. + Proficiency in Excel, Word, Outlook, and database applications. + Ability to travel (may include overnight travel). + Should reside in territory geography or be willing to relocate. + Valid Driver's License and an acceptable driving record. + Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. + Strong understanding of managed care environment and intricacies of health systems of varying size, control and willingness to partner. + Expertise in account management and knowledge of territory. + Regulations such as EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. \#LI-DG1 All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $81k-103k yearly est. 47d ago
  • Associate Director, Project Management and Engineering Services

    Boehringer Ingelheim Group 4.6company rating

    Gainesville, FL job

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director, Project Management and Engineering Services will lead and execute capital projects with a focus on areas such as Clean Utilities, cleanroom HVAC, infrastructure, facilities, and process equipment (bio & pharma). The role involves managing projects from early planning states (FEL-1 and business case development) through to final handover to the end user. Beyond project execution, this position will provide subject matter expertise and strategic support for cross-functional initiatives, troubleshooting and high-priority topics across a network of Boehringer-Ingelheim locations. Duties & Responsibilities Having deep knowledge in the design and function of the specific area of expertise (ex. Clean Utilities, cleanroom HVAC, infrastructure, facilities or process equipment (bio or pharma) and responsible for knowing state-of-the-art solutions, while being able to challenge the status quo at a site. Executes the global CapEx project manual, secure capital committee approvals (LCC, CIC & CEMCom) meetings and ensure compliant project approval. Be member of the regional and global project management team and further develop the CapEx Execution manual as team member. Prepares User requirements in alignment with the site user team. Sets up project execution plan incl. common project documents according to respective CapEx project manuals. Executes projects in alignment with the SD4G carbon neutral path of each site and considering most sustainable options for each project. Delivers projects compliantly, on time and within budget Responsible for continuous project reporting according to existing project delivery manual. Points out and manages project risks, escalating early enough major project impacts Follows current project documentation guidelines and using standardized project tools. Documents project after hand-over and sharing lessons learned with local, regional and global PM teams. Requirements Bachelor/Master degree or comparable in Engineering (Mechanical, Electrical or Chemical) in combination with five to ten (5-10) years of experience in project management & project execution in a sensitive environment, i.e. hospitals, pharmaceutical plants, clean rooms, central utility plants or similar required. Core Capabilities & Competencies Business/Technical Knowledge: External Focus Fast and Focused Execution Teamwork and Collaboration Management Competencies Stakeholder Management Managing Performance Functional Competencies: Communicates Effectively Knowledge of Policies and Procedures Problem Solving Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.
    $93k-116k yearly est. 60d+ ago
  • Associate Director/Sr. Associate Director, PCP/Endo - Tampa, FL

    Boehringer Ingelheim Group 4.6company rating

    Tampa, FL job

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director, Diabetes Business Management is responsible for the management of the assigned specialists and for business development with a select group of key external experts and accounts. The incumbent will direct their specialists in developing and implementing territory business plans for maximizing net sales of BIPI and co-promoted diabetes products that align with direction from BIPI commercial leadership and with BIPI guidelines, policies, and directives. The Associate Director, Diabetes Business Management ensures equal and consistent application of established policies and procedures in the management of employees to meet or exceed sales goals. Duties & Responsibilities Develops, enhances, and increases district performance of BIPI's diabetes portfolio to meet or exceed annual company net sales. Implements a District sales strategy (District business plan) to be executed through the specialists. Exercises fiscal control on allocated operating budgets. Recruits and selects Top Talent applicants from a pool of highly qualified diverse candidates to ensure all allocated positions are filled. Proactively develops pool for specialist talent. Effectively administers salary and reward programs. Retains talent with demonstrated successful performance results. Applies appropriate coaching styles to each direct report that motivates high performance and ensures accountability. Provides regular, candid, and timely feedback during days in the field and via remote coaching conversations, which is documented in Coaching for Excellence and MAG plans. Ensures all direct reports have actionable Development Plans that grows talent for increased responsibility. Acts early to identify performance challenges or deficiencies and creates plans to appropriately address performance gaps. Works in close partnership with Regional Director and HR, to guide all disciplinary action in the District, up to and including terminations. Analyzes and evaluates the performance of the district. Cultivates teamwork by participating in cross-functional, Regional & HQ meetings to develop district business plans and utilizes appropriate data sources to develop district tactical plans. Manages district at a high level of productivity. Facilitates cross-district communications, projects and activities. Plans and executes district meetings that effectively implement objectives and strategies as determined by the Company. Acts as the customer channel expert for his/her district and models sales excellence to their direct reports. Spends appropriate amount of time independently developing prioritized external experts and emerging accounts and their relationships to foster Company business. Responds to the needs of the customer in a timely and professional manner. Develops a highly integrated district business plan and contributes to the development of the zone business plans. Develops positive and mutually beneficial relationships with Company internal customers, with key accounts in all classes of trade and with BIPI's co-promotion partners to meet all assigned Company sales goals. Works effectively with all customer-facing roles (i.e., Account teams, Medical teams, etc.) in each geography to meet customer needs and deliver net sales objectives. Demonstrates strong collaboration and communication as customers evolve and ownership of accounts transition from traditional to account based. Communicates candidly with supervisor and direct reports. Associate Director PCP/Endo Requirements Candidate will be hired at the level commensurate with their experience. Manager Requirements • Bachelor's degree from an accredited institution required. • A minimum of four (4) years successful pharmaceutical sales experience required. • Requires at least one of the following: o Two (2) years successful pharmaceutical District Manager/Business Manager experience with experience in the geography strongly preferred, OR o Successful completion of at least stage 4 of the NLD (BI New Leadership Development) curriculum, OR o Successful completion of at least stage 3 of the NLD (BI New Leadership Development) curriculum with at least six (6) months experience as an Interim Business Manager • History of successful performance including the last two performance reviews. • Demonstrates acceptable level of performance for all TBM competencies and AAI Behaviors • Proficiency in Excel, Word, Outlook, and database applications. • Expertise in pharmaceutical regulatory and compliance environment. History of successful management in pharmaceutical industry required. • Must be eligible and authorized under all U.S. Export Laws. • Ability to travel (may include overnight travel). • Should reside in territory geography or be willing to relocate. • Valid Driver's License and an acceptable driving record. • Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. • Physical Demands / Surroundings • Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. • Visual Demands • Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. • Temperaments/Mental Requirements • Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. • Level of Proficiency • Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. • Attendance / Schedule • At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. • These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. Senior Associate Director PCP/Endo Requirements Bachelor's Degree from an accredited institution required. • Seven-plus (7+) years of successful pharmaceutical sales experience required. • Four-plus (4+) years of successful pharmaceutical Sales Manager experience required with experience in the geography strongly preferred. • History of successful performance including the last two performance reviews. • Demonstrates acceptable level of performance for all TBM competencies and AAI Behaviors • Proficiency in Excel, Word, Outlook, and database applications. • Expertise in pharmaceutical regulatory and compliance environment. • History of successful management in pharmaceutical industry required. • Must be eligible and authorized under all U.S. Export Laws. • Ability to travel (may include overnight travel). • Should reside in territory geography or be willing to relocate. • Valid Driver's License and an acceptable driving record. • Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. • Physical Demands / Surroundings • Daily Travel within territory throughout the workday with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. • Visual Demands • Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. • Temperaments/Mental Requirements • Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a high competitive environment. • Level of Proficiency • Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. • Attendance / Schedule • At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self directed work environment. • These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed.
    $82k-117k yearly est. 60d+ ago
  • Technician II, Production 2

    Boehringer Ingelheim 4.6company rating

    Gainesville, FL job

    The main purpose of this role is to assist in all tasks associated with the production of Non-Marek’s bulk vaccines and master these tasks as outlined in the departmental procedures. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities Assists in the following areas of Non-Marek's vaccine production: TS-11, Cocci and Autogenous. Performs all processes in accordance with Standard Operating Procedures. Communicates any occurrences/deviations to SR Ops Process Leader / Team Leader / Group Leader immediately. Always utilizes sterile technique and gowning technique. Active knowledge of working under laminar flow hoods and HEPA filtered environment. Responsible for keeping the lab area and all other working areas clean, sterile, and in compliance always. Works well independently and within a team environment. Works cooperatively with SR Ops Process Leader / Team Leader / Group Leader to train others. Must be able to accurately measure liquid volume, convert units of measure, and perform moderately complex calculations. Communicates well with fellow team members regarding daily tasks. Always is prepared for the day ahead. Maintains accurate and timely manufacturing records, this includes all paperwork and files. Actively promotes safety awareness in the lab, always acting in accordance with safety practices. May assist in the candling of eggs at the incubation department. Assists with washing, wrapping, and sterilizing glassware. Assists with transporting raw materials and finished product in and out of the lab areas. Completes daily/weekly job duties assigned monthly by SR Ops Process Leader. Performs other duties as assigned. Requirements B.S. in biology or science related field or 5 plus years of Marek's or Non-Marek's lab experience. Required knowledge of non-Marek’s technical processes. Is fully trained and can work independently in the following areas of Non-Marek's vaccine production; Commercial Ovo culture ' Tissue Culture bulk production. Ability to lift 50 pounds and carry 10 feet. Must be a team player. Must be able to lift 50 lbs. and carry it 10 ft. Must be able to squat, bend, and stoop, as well as twisting and turning. Manual dexterity and visual acuity are important. Must be able to wear appropriate Personal Protective Equipment (PPE.) Must be able to stand on feet for long periods of time and work in a sterile production environment. Must be flexible with availability (able to work overtime as needed on short notice). This position requires weekend work. Regular attendance is a must. Must possess the ability to work unsupervised, work well under time constraints, can think ahead to the next task, and be self-motivated. Ability to think ahead to next task. Ability to work well under time constraints. * Avian Biosecurity Policy: It is the responsibility of all Boehringer Ingelheim Animal Health, Inc. employees to take necessary steps to avoid contact with the avian species in general. This includes, but is not limited to, commercial poultry, yard chickens, turkeys, ducks, geese, wild birds, and pet birds. Should contact occur, precautions must be taken prior to entering a critical building or location: Anyone encountering the avian species should not enter a critical building or location for 24 hours unless they have showered, changed clothes and shoes.
    $49k-62k yearly est. 60d+ ago
  • Technician II

    Noven Pharmaceuticals 4.6company rating

    Noven Pharmaceuticals job in Miami, FL

    Provide technical support to manufacturing, engineering and other departments / teams by ensuring maximum equipment uptime, and addressing technical challenges. When not supporting manufacturing, technician shall perform scheduled PMs in timely manner as required by the CMMS system for work orders. Lastly, under limited supervision, performs and documents moderately complex technical functions relating to test, layout, quality control, fabrication, modification and assembly of mechanical equipment and/or components. Responsibilities Ensures maximum uptime of manufacturing equipment by completing preventive maintenance requirements. Provide continuous feedback on preventive maintenance effectivity and improvements to the instructions based on usage and experience. Executes scheduled Preventive Maintenance on manufacturing equipment in timely manner to always meet due dates. Works with manufacturing to monitor and quickly resolve technical issues on manufacturing equipment. Perform or assist with any production operation to maintain work flow or prevent downtime per production requests. With minimal supervision, performs moderately complex testing, troubleshooting, debugging, installation and repair of components, sub-assemblies and systems to isolate root cause and suggest remedies. Performs in-house inspection, maintenance and cleaning of all tooling required for changeovers within all areas of production. Prepares and provides manufacturing with tooling required for changeovers per production schedule. Execute repeatable setup procedures, maintains and cleans semi-complex manufacturing equipment and performs equipment alignment for each size/product. Must know all setup requirements for manufacturing lots. Must be able to identify issues encountered during day to day tasks, diagnose its cause and develop and implement a solution. Ensures equipment/tooling is properly calibrated / inspected before using. With training provided, demonstrates the ability to operate machinery to produce components and products. Reads and follows SOPs, work instructions and protocols. Contributes to the development and improvement of these documents. Accurately documents changes to any equipment used in the development, testing or manufacture of products as per respective SOPs, i.e. in logbooks, work orders, data entry, data sheets, etc. Verify GMPs and safety standards are maintained at all times and take action and/or follow-up when deficiencies are noted. Follow lockout/tag out procedures. Maintains a clean, orderly and organized work environment. Practices safe work habits and completes required safety and environmental hazard training. Able to interpret MSDS sheets. May work closely with engineers or other technical team members during process development using limited documentation and only general support. May offer feedback and improvement recommendations based upon findings. With necessary guidance, records test procedures and results, numerical and graphical data, and recommendations for changes in product or test method. Performs updates to the SOPs related to role, as well as to PM instructions. Able to use metrology equipment (indicators, comparators, microscopes, micrometers, etc.). Ability to multitask and assess priorities. Able to read and understand engineering drawings. AutoCAD or SolidWorks skills are desired. Communicates effectively with personnel at all levels and effectively participate in a team environment, particularly for effective shift transitions. Inform appropriate personnel of improvement ideas, problems or concerns. Must be able to work additional hours, or beyond standard schedule, including holidays and weekends with little or no notice. Maintains Noven's compliance training. Qualifications Competencies: Must have intermediate knowledge of mechanical, hydraulic, pneumatic and electrical systems. Strong writing and oral skill as well as technical editing skills. Ability to work independently with minimal supervision within established procedures, providing efficient, effective and reliable services. Ability to work with internal and external constituents Able to make appropriate decisions with minimal intervention Knowledge of proper power tools usage. Ability to contribute to a team environment. Excellent organizational skills. Strong communication skills Computer literacy in Microsoft Office is preferred. Education / Experience: Associate's Degree (AA or AS) or equivalent; or trade/technical schooling and 5-9 years of related experience and/or training; or the equivalent combination of education and experience. Pharmaceutical industry work experience is a plus. Ability to use computer and associated software. Judgment / Decision Making: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Use detail-oriented problem solving skills to assist in solving difficult mechanical or electrical issues. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form Work Environment: Production/plant floor - pharmaceutical products Physical Demands: The employee will be occasionally required to climb or balance; stoop, kneel, crouch, or crawl; and smell. The employee must be able to lift and/or move up to 100 pounds.
    $17k-34k yearly est. Auto-Apply 8d ago
  • QA Inspector - TEMP

    Noven Pharmaceuticals 4.6company rating

    Noven Pharmaceuticals job in Miami, FL

    Perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP's, Safety initiatives, Company policies, FDA and DEA regulations. Document all work performed, ensuring accuracy and thoroughness. Inform management of any deviations from established standards/procedures. Responsibilities Inspect and approve rooms, lines and equipment prior to use by manufacturing and R&D personnel. Approve components for in-process operations. Monitor manufacturing areas for compliance with internal SOPs, cGMPs and FDA/DEA regulations. Document all work activity in appropriate batch records, forms, and logs to ensure accuracy and compliance. Sample in-process items, and finished products. Perform required inspections and testing of in-process items and finished products. Process and distribute samples to different departments. Review records for cGMP compliance for accuracy and thoroughness. Inform management of problems, failures and deviations from established internal and regulatory standards. Apply disposition sticker to components and in-process materials. Issue QA Alerts whenever any questionable component, in-process material or product is identified at any stage of production or storage. Perform swab and Rodac Plate sampling as required. Perform transactions in JD Edwards when required. Qualifications Competencies: Education / Experience: High school diploma or equivalent. Basic computer skills required. Basic math skills required (i.e., calculating %, addition, subtraction, multiplication, division). Ability to read, write, communicate and follow instructions (verbal and written) in English is required. Judgment / Decision Making: Duties performed within a framework of departmental or functional protocol requiring a minimal degree of original thinking. Work Environment: Majority of time spent at manufacturing plants with exposure to machines with moving parts airborne products, chemicals, muscular strain and noise. Carelessness could result in minor injury. May handle or work with laminates and units containing a Class II Controlled Substance. Ability to work second and third shift, if required. Ability to work Saturday and/or Sunday, if required. Physical Demands: Regularly required to stand for more than one hour at a time; occasionally lifts and carries objects weighing up to 50 pounds. Visual acuity and manual dexterity required to proofread documents and operate computer.
    $25k-38k yearly est. Auto-Apply 8d ago
  • Engineer

    Noven Pharmaceuticals 4.6company rating

    Noven Pharmaceuticals job in Miami, FL

    Provide technical support to manufacturing, engineering, and other departments while working on assignments that may be complex in nature. Responsible for design and implementation of manufacturing processes using considerable judgment and initiative for resolving design and implementation issues. Apply engineering principles and standards for electrical, mechanical, electromechanical, and /or optical procedures and tests in areas such as manufacturing, development, maintenance, quality, testing, and engineering projects. Design, establish specifications, construct, inspect, adjust, test, document and maintain equipment, components, devices and systems following proper procedures and instructions. Provide guidance, training and direction to junior or non-technical employees. Responsible to create and edit maintenance and technical procedures as required. Supervise a team of technicians. Responsibilities Strong writing and oral communication skills with in depth knowledge of Microsoft Word, Excel, and PowerPoint. Ability to work under pressure on multiple tasks with varied deadlines. Ability to work independently as well as with key internal and external constituents. Strong organizational skills and the ability to multi-task and integrate project segments. Follows Standard Operating Procedures, Protocols, Work Orders, Company Policies, and work instructions from supervisors in the course of performing his / her work functions. Performs all work in adherence to the Company's cGMP and safety standards and procedures. Maintains, organizes, and keeps all engineering and other company documentation associated with Noven's manufacturing equipment in an orderly manner. Contributes to the development and improvement of these documents. Accurately inspects and measures critical aspects of electromechanical components; creates and/or follows engineering drawings, and wiring diagrams. Works from and or establish specifications, drawings, manuals, sketches and verbal instructions. Able to accurately measure and inspect mechanical, electromechanical or electrical parts and equipment using complex metrology equipment (oscilloscope, voltmeters, indicators, comparators, microscopes, micrometers, etc). Maintains a clean and orderly work environment. Practices safe work habits and completes required safety and environmental hazard training. Able to interpret MSDS sheets. Examines equipment, machinery, building components and associated mechanical and electrical components to determine condition and need for work and determines need for replacement parts or repairs. Assist with the fabrication of new or custom-built manufacturing, research, development, and test equipment. Including software and hardware related development. Applies an extensive practical experience and knowledge base to develop alternative solutions to electrical / electronic or mechanical problems which may be of a difficult and / or unusual nature. Accurately complete the required documentation (logbooks, work orders, data entry, data sheets etc.) pertaining to installation, maintenance, spare parts holding and trouble-shooting of Noven's manufacturing equipment. Adhere to Noven policies regarding cGMP Good Documentation Practices. Work closely with team and group members to achieve defined goals, and communicate effectively in recording work performed, and in offering feedback and improvement recommendations based on observations and work experience. Performs operational functional testing, troubleshooting and debugging of components, sub-assemblies and systems to isolate faults and suggest remedies and recommendations for changes in product or test method in a team environment Writes technical reports and develops charts, graphs and schematics to describe and illustrate systems/tests operating characteristics, malfunctions, deviations from design specifications, and functional limitations. Executes IQ/OQ protocols related to equipment installation and/or modification. Performs process/product tests and audits for conformity to quality and/or regulatory requirements. Records test procedures and results along with the appropriate data analysis. Performs such individual assignments and related duties as the supervisor may direct; establishes and maintains effective work relationship within the department, facility and company. Participates/leads in the design, development, execution and support of engineering projects including the drafting of technical documentation/procedures. Contributes to the design of tools and equipment that are critical to Noven operations. Conducts testing and troubleshooting of equipment and incorporates lessons learned in future improvements/projects. Capable of working on equipment and processes with minor supervision and takes the lead in developing improved solutions, including collaborating with vendors. Regularly providing design ideas and equipment improvements independently as well as in collaboration with fellow team members. Managing of tasks and assignments to guarantee the timely execution with a high level of certainty on their success. Working closely with several departments to provide continual support, resolve issues and coordinate additional testing, as needed. Development of cost reduction project using lean tools. Developing positive relationships with fellow employees to ensure equipment improvements contain the needed requirements and that changes are met with minimized interruptions to current process. Continually providing support and guidance to ensure transfer of equipment and process knowledge is sufficient in a continuous effort to improve equipment functionality and reduce down time. Qualifications Competencies: Education / Experience: Bachelor's degree within an engineering discipline preferred or the equivalent technical training. Three to six years of professional experience. Good written and verbal communication skills in English. Knowledge of CGMPs and FDA CFR's. AutoCAD and PLC programming/troubleshooting a plus. Must be computer literate with knowledge of office application software (Microsoft Word, Excel, PowerPoint, ACCESS, and Outlook). Judgment / Decision Making: Effectively identifies problems as they occur and takes appropriate steps to solve straight-forward problems. Under general supervision, exercises some judgment in accordance with well-defined policies, procedures, techniques. Works on assignments that may be complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations. May determine methods and procedures on new assignments and may provide guidance to other non-exempt personnel Work Environment: Air-conditioned office environment. Majority of time spent sitting at desk, operating computer and talking on telephone. Majority of work performed with exposure to chemicals, electrical current, fumes, moving parts, noise, and odors. Physical Demands: Visual and manual dexterity required to perform clerical duties, including operating office equipment and checking documents for accuracy. Occasionally required to lift and carry objects weighing up to fifty (50) pounds. Standing is often required, as well as stooping and bending. Visual acuity and manual dexterity required when performing essential duties; carelessness could result in injury.
    $78k-105k yearly est. Auto-Apply 8d ago
  • QC Analyst II

    Noven Pharmaceuticals 4.6company rating

    Noven Pharmaceuticals job in Miami, FL

    Performs professional, technical laboratory functions with versatile capabilities throughout the laboratory. Serves as a technical resource in the laboratory providing scientific expertise and problem-solving skills. Responsibilities The Analytical QC Analyst II is an integral part of the team, contributing to our success by performing raw materials and commercial pharmaceutical products testing according to compendial methods and/or internal standards test procedures (STPs). Conducts Analytical testing of Raw Materials, Intermediate Products and Finished products as per written procedures and protocols to support material/product release, stability studies, method transfers, method verifications and investigations. Troubleshoot, operate, and train for testing associated with general analytical instruments for testing of raw material, in process and finished products using instruments such as HPLC, GC, Dissolution, UV, IR, automatic titrator, and viscometer. Ensures testing is properly conducted and documented for all performed activities with emphasis on data integrity. Prepare test solutions, volumetric solutions, and samples used in analysis. Performs assigned physical tests, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished, components, and stability products in an FDA regulated lab environment. Notifies supervisor immediately regarding testing abnormalities, OOS/OOT results, and deviations from established testing procedures. Serves as a lead investigator in conducting and documenting the investigation. Functions as a subject matter expert within the analytical laboratory and always provides support. Performs training and provides technical support to junior analysts as required. Works under minimal supervision and is expected to independently carry-out non-routine assignments. Actively completes assigned training activities and documents training within assigned time frames and before performing any activity associated with the training topic. Maintains proper documentation of laboratory data (which requires adequate proficiency in written and computational skills). Reviews analytical testing records/logbooks for compliance with cGMPs, compendial requirements, and Noven procedures/protocols. Reviews and/or writes technical reports, procedures, and protocols. Draws conclusions from data and communicates those conclusions is writing. May Schedule laboratory testing and associated activities to minimize operational disruptions to departments. May manage inter-departmental projects to ensure timely completion of objectives. Completes any other duties assigned by QC management as required. Qualifications Competencies: Education / Experience: Minimum of four years of experience with a bachelor's degree in chemistry or related scientific field required. Alternately, three to six years of experience with a master's degree in chemistry or related scientific field. Alternately, zero to three years of experience with a PhD in chemistry or related scientific field -Required. Broad knowledge of scientific principles, methods, chromatographic analysis, analytical methods (i.e. HPLC, GC, Dissolution) and a good understanding of separation theories -Required. Candidate must have broad knowledge in all types of compendia testing (USP, EP, JP, BP) and wet chemistry techniques-Required. Good written English and verbal communication skills-Required. Must be highly organized and able to work under pressure. Must have strong interpersonal and leadership skills. Must be computer literate with knowledge in all Microsoft business applications. Strong background in scientific software such as Waters Corp. Empower and LIMS is a plus. Judgment / Decision Making: Duties are performed under general direction toward broad assignments with periodic reviews. Duties are performed within framework of departmental or functional guidelines, requiring interpretation and original thinking. Work Environment: A laboratory environment with exposure to chemicals, caustics, fumes, heat and electrical current. Physical Demands: Visual acuity and manual dexterity required to operate computer, analytical instrumentation, sample preparation and proofread documents. Majority of time spent sitting and walking. Often required to lift objects weighing up to 20 pounds.
    $42k-62k yearly est. Auto-Apply 8d ago
  • Pharmaceutical Sales Specialist, CVRM Primary Care - Miami Beach, FL

    Astrazeneca PLC 4.6company rating

    Miami, FL job

    At AstraZeneca, we turn ideas into life-changing medicines. Working here means thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. Our ambition is to improve and save lives for the millions of people who are living with the complexities of Cardiovascular, Renal & Metabolic (CVRM) diseases. AstraZeneca is uniquely positioned to improve the outcomes of patients living with CVRM diseases today and tomorrow with our strong and expanding portfolio and one of the broadest, deepest, most innovative pipelines in the industry. By 2032, we intend to be leading the world in CVRM therapies, launching up to 15 new life-changing medicines. To support our future growth, we have an exciting opportunity as a Primary Care Sales Representative to launch a best in class hypertension asset. At AstraZeneca, we are taking bold action on climate because we recognize the connection between healthy people and a healthy planet. As part of our flagship Ambition Zero Carbon program, we have committed to a fully electric vehicle (EV) fleet by the end of 2025, which means that all our drivers will be assigned an EV. As a Pharmaceutical Sales Specialist for the Primary Care Team, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives! Accountabilities • Develop and demonstrate knowledge of clinical disease states and treatment guidelines. • Effectively communicate product information to healthcare professionals. • Execute call plans and Brand Strategy by translating data to actionable insights. • Adapt to and demonstrate a thorough understanding of AZ Selling Model. • Analyze data and trends to build insightful and actionable business plans for your assigned sales territory. • Build relationships and credibility with Primary Care healthcare professionals to effectively position products by establishing unmet needs, clinical differentiation, and fair balance of our Brands. • Leverage multiple channels including digital platforms and face-to-face engagements to drive meaningful customer interactions. • Open to receiving guidance and seek insights for growth and development. Essential Skills/Experience • Bachelor's Degree • 0 - 2+ years of demonstrated Sales or B2B, or Commercial experience • A valid driver's license and safe driving record Essential Skills and Capabilities • Customer Focus: Strong customer relationship management skills with the ability to understand and address customer needs. • Business Acumen: Ability to analyze and interpret complex data to develop strategic sales plans. • Technical Aptitude: Proficiency in using digital tools and platforms to engage with healthcare professionals. • Adaptability: Flexibility and adaptability to changing market conditions and customer needs. • Collaborative: Ability to work effectively in a team environment and collaborate with cross-functional teams. Desirable Skills/Experience • Experience selling to general practitioners (GPs) and primary care centers • In-depth understanding of the healthcare industry and primary care operations At AstraZeneca, we are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear. We shape the future by spotting scientifically-led commercial opportunities and acting now to operationalize and scale them. Driven by the solutions we bring to the healthcare ecosystem, we make an impact at every step of the patient journey, improving their experience and outcomes. Our team thrives on energy and pace, constantly thinking big to answer new challenges. We lead Commercial to provide solutions that make a difference, improving our patients' experience and health outcomes. Join us in making a difference in patients' lives - apply today! Date Posted 06-Jan-2026 Closing Date 19-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
    $128k-197k yearly est. 13d ago
  • SR AD, Global Facilities Engineering

    Boehringer Ingelheim Group 4.6company rating

    Gainesville, FL job

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. As an integral member of the Site Leadership team, the Senior Associate Director, GFE and Engineering & Technology has end to end accountability for the Global Facilities & Engineering (GFE) and Engineering & Technology (E&T) functions. This role is responsible for executing global strategy and regional action plans for , and for managing / optimizing site performance. The Local Head of GFE / E&T ensures: Pursuit of GFE / Business Unit (BU) strategy from a Site Services perspective, incl. adherence to global standards for GFE and local regulations. Tactical leadership of capital investment budgeting, asset management and engineering project execution. Execution of fast, agile, and high-quality Site Services following common standards. Reporting to Head of GFE and Head of BU Global Engineering (GE) on local & site-specific regulations compliance, & actions to protect BI's reputation. Proactive management of the organizational risks on site. Safety and security of BI employees and assets. Leadership, people development and employee reviews. The SR AD, GFE and E&T is accountable to execute and adhere to global GFE solutions across site GFE / E&T functions, consistent with BU requirements. This role has end-to-end accountability to safeguard effective solution delivery and performance management for local GFE / E&T functions. Duties & Responsibilities Leads, oversees, and directs these functions: Engineering (including Process Engineering, Automation, Maintenance & Digitalization), Real Estate & Facility Management, Environmental, Safety, Sustainability and Security. Accountability for budget oversight, capital project management, sustainability targets, and facility, plant, utility, environmental & security operations. Aggregates & approves budget proposals from site GFE / E&T functions & communicates to the regional level. Implements priorities and targets as defined by Global/Regional Head of GFE and Head of BU GE. Ensures local targets are coherent for GFE / E&T functions (no conflicting targets). Safeguards effective solution delivery by aggregating and reporting GFE and E&T function performance, quality, and compliance to the regional / global level. Develops and executes key technical engineering strategies within production areas to improve critical process efficiency / performance. Ensures process improvement projects are incorporated into strategic CapEx and OpEx plans / budgets. Develops & effectively manages CapEx Project execution based on site, regional & global BU strategy. Ensures CapEx management meets Corp. standards & procedures. Collaborates with GFE Project Management for Strategic Projects (over 50M EUR) Oversees execution of selected services on site according to defined standards & performance levels. Ensures best practice sharing across GFE/E&T functions (if applicable). Reviews & aligns local or BU-specific adaptations of global concepts, standards, and processes with Regional Head of GFE / Head of BU GE when required. Accountable to ensure all regulatory and (site-specific) legal requirements are being followed. Ensures safety and security of BI assets and employees as well sustainability of services and facilities. Oversees Talent Management and employee lifecycle for GFE/E&T functions on site level. Requirements University degree in the respective field of responsibility. Five to ten (5-10) years of experience on a site in a leading position. Three to five (3-5) years of experience in one or more GFE and E&T functions present at the site. Proven track record in site operations. Routine exposure to inspections / audits (agencies, customers, suppliers, etc.) with successful outcomes. Proven team & individual performance management, including coaching and development, leading to consistent delivery of targeted results. Visionary leadership competencies & passionate team player (also in virtual setting) Service orientation and customer focus. Multi-cultural awareness and understanding. Internal / external networking across functions and different executive levels. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Desired Skills, Experience and Abilities
    $96k-120k yearly est. 60d+ ago
  • PCP/Endo Business Specialist-West Palm Beach

    Boehringer Ingelheim 4.6company rating

    Palm Beach, FL job

    The PCP/Endo Business Specialist is responsible for developing and implementing a plan for maximizing net sales of BIPI and co-promoted diabetes products that aligns with direction from BIPI commercial leadership and with BIPI guidelines, policies, and directives. The PCP/Endo Business Specialist will conduct their business with key targeted healthcare providers and community hospitals, and may have additional responsibilities in teaching hospitals, federal and military hospitals, managed health care facilities, group purchasing organizations, integrated delivery networks, etc. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Duties & Responsibilities** + Utilizes product knowledge and demonstrated selling skills in order to influence targeted health care professionals to support the use of BIPI promoted diabetes products. Executes brand strategies to ensure that company sales and marketing messages are delivered appropriately to customers. Establishes and maintains effective communication/cooperation/coordination with co-promotion partners and BIPI employees. + Completes pre-call plans to meet key stakeholder needs. Builds discussion around customer needs and opportunities. Fosters customer network development and communication. Has accurate and timely follow-up discussions with customers. Fosters ongoing trust with customer as relationship develops. Uses appropriate BIPI Sales Training techniques to facilitate the customer decision making process. Coordinates the engagement of healthcare providers through a range of personal and non-personal channels, according to customer preferences. + Identifies top plans for customers. Engages customers in comprehensive discussions on the payer environment, co-pays, and formulary access. Works with Managed Care Area Managers to generate and sustain support for products on MCO formularies. Develops and influences an extended team to pull-through MCO decisions. Delivers on "continuation of care" model, including discharge protocol, treatment algorithms, disease management, etc. + Analyzes qualitative and quantitative territory information to optimize territory business plan and customer calls. Monitors local market conditions for changes that impact business. Develops plans to optimize allocation of key resources, including samples, co-pay cards, funds for speaker programs, and funds for in-office meals. Adjusts implementation plans on a regular basis (speaker mgmt., advocate development, etc.). Leverages opportunities that meet both territory and brand tactics. Utilizes supporting analysis tools to plan activity, report and monitor resource utilization, and maintain account and customer records. Completes all administrative responsibilities as directed by management. Successfully completes all Sales Training requirements. + Identifies thought leaders, innovators and advocates to support BIPI products. Works with trained speakers for diabetes topics and products. Provides feedback and follow-up to speakers and attendees. Initiates contacts and network-building among advocates and customer groups. Develops plans to develop speakers and thought leaders. Manages programs and budgets to stay within standards. + Works effectively with all customer-facing roles (i.e. Account teams, Medical teams, etc.) in a given geography to meet customer needs and deliver net sales objectives. Demonstrates strong collaboration and communication as customers evolve and ownership of accounts transition from traditional to account based. + Performs all Company business in accordance with all regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community. **PCP/Endo Business Specialist Requirements** Bachelor's degree from an accredited institution is preferred. A minimum of two (2) years successful sales and/or marketing experience in pharmaceutical/healthcare industry, pharmacy, B2B, customer engagement services or equivalent Experience in diabetes therapeutic area preferred. History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. "Export Laws" means the Export Administration Regulations ("EAR") of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time. **Executive PCP/Endo Business Specialist Requirements** Bachelor's degree from an accredited institution preferred A minimum of five (5) years successful sales and/or marketing experience in pharmaceutical/healthcare industry, pharmacy, B2B, customer engagement services or equivalent Experience in diabetes therapeutic area preferred History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. "Export Laws" means the Export Administration Regulations ("EAR") of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $126k-202k yearly est. 60d+ ago
  • Quality Engineer

    Noven Pharmaceuticals 4.6company rating

    Noven Pharmaceuticals job in Miami, FL

    · The primary purpose of this position is to lead Quality Engineering (QE) activities for product and process support including Validation of Manufacturing Processes, Cleaning Processes, and Test Methods, Qualification of Equipment, Utilities, and Facilities, Risk Management, and Annual Product Reviews. · Develop and maintain quality engineering methodologies, systems, and practices which meet quality and regulatory requirements. Assure awareness, visibility, and communication to support departmental, functional, site, and corporate quality goals and priorities. Master Statistical Analysis, Product evaluations, Risk Analysis, investigations, qualification/validations as minimum to support Commercial Operations and R&D areas. · This individual works with minimum supervision using his/her experience, expertise, and sound knowledge to assure the quality of our systems, and products comply with NOVEN policies, procedures, and regulatory bodies' guidance and regulations. · This individual will be expected to apply his/her knowledge of product, development principles, and quality engineering to develop procedures and processes that ensure sustaining activities and successful development of products to positively influence commercial and/or new product launches to ensure they are developed, validated / qualified, and manufactured in accordance with regulatory and quality requirements. Responsibilities Actively represents QE function on product development and manufacturing teams. Implementing ICH guidelines requirements with requisite elements of Q8, Q9 and Q10. Facilitate Quality Risk Analysis using appropriate risk management tools (eg. RMP, HA, U/D/P FMEA, FMECA, PHA, RMR etc.) in accordance with ICH Q9 and ISO 14971:2019 requirements. Draft and execute protocols for equipment, utilities, and facilities qualification for adequateness to the manufacturing processes. Support in supplemental documentation, such as functional specifications, system risk assessment, and system impact assessment. Perform process validation, cleaning validation, and test method validations in accordance with FDA and Noven requirements. Generate, review, and/or approve, execute validation/qualification protocols and reports to ensure that the product design, evaluation, and testing is sufficient to meet Noven quality requirements, regulatory requirements and quality objectives. Promote the use of statistical and six sigma tools to determine root cause and actions implementation. Actively participates in the generation quality characteristics, process or product specifications, inspection plans, and control strategies during development for components, raw materials, and new finished products. Identify and implement effective process control systems to support the development, qualification, and on-going / continuous process verification to assure the manufacturing of products meet or exceed internal and external requirements and is maintained in a state of control. Apply sound, systematic problem-solving and lean six sigma methodologies for identifying, prioritizing, communicating, and resolving quality issues. Support development, implementation and deployment of quality initiatives (e.g. APQR, Quality by Design, Risk Analysis and Process Analytical Technology). Develop and/or write Continuous Process verification, Annual Product Review (APR) reports, and/or performs Statistical Analysis of products under commercial manufacture Performs training and provide technical support Actively participate in the implementation of computerized /paperless systems (eg. LIMS, MES) by providing guidance on the requirements for ICH Q10, APQR, QbD, and CPV. Update quality systems for all stages of product development including but not limited to product engineering/development, prototype testing, and commercialization. Drive Quality first within all facets and phases of development and sanction QE metrics across the organization. Collaborate closely with product development and manufacturing to deliver high quality products to our customers. Draft and implement specification, procedures, master validation plans, protocols, and reports for product life cycle, sustaining commercial activities including qualification protocols and reports. Carry out Continuous Process Verification (CPV), Annual Product Quality Review, post market surveillance, and other product and process lifecycle reports. Qualifications Sound knowledge of quality tools using: Pharmaceutical development (ICH Q8(R2)) Risk analysis (ICH Q9 or ISO 14971) Pharmaceutical Quality System (ICH Q10) EMA/CHMP/QWP/*********** - Guideline on quality of transdermal patches Industrial use in applied statistical techniques and statistical analysis software (e.g. MiniTab, SIMCA-Q) Lean Six Sigma Principles and/or Operational Excellence Strong understanding of GxPs Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP); Project Management principles; and ICH Q8, Q9, and Q10 procedures. Other Elements Education & Experience: A minimum of a bachelor's degree in science or engineering or associated fields is required. Mechanical, Biomedical, or Chemical Engineering preferred. Bachelor's degree in other Engineering or Science discipline with relevant equipment understanding. A minimum of 5 years of experience in Quality Engineering performing equipment qualifications and process validations. Experience in transdermal systems or combination products preferred. Strong written/verbal communication skills. Demonstrated use of Quality tools and methodologies in a pharmaceutical, medical device, or biotech sector. Applied Statistical analysis, Statistical Analysis software experience and expertise. Certified Quality Engineer (CQE) desired. High proficiency with Microsoft Word, Microsoft Excel, Power Point and statistical software packages (e.g., Minitab) is strongly desired. Strong documentation skills are required. Master's degree in Engineering preferred. Ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required. Supervisory Responsibilities: N/A Travel: Less than 10% Working Conditions Work Environment: Air-conditioned office environment. Some time spent in the laboratories and manufacturing with exposure to chemicals and moving parts. Physical Demands: Visual acuity and manual dexterity required to review documents and operate a computer.
    $59k-81k yearly est. Auto-Apply 8d ago

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Noven may also be known as or be related to Noven, Noven Pharmaceuticals, Noven Pharmaceuticals Inc and Noven Pharmaceuticals, Inc.