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Precision For Medicine jobs

- 497 jobs
  • Regulatory Manager

    Precision for Medicine 4.6company rating

    Remote Precision for Medicine job

    The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function. Essential functions of the job include but are not limited to: Provides regulatory guidance throughout the clinical development life cycle Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications. Also provides strategic regulatory input as required. Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers Works within a project team, and where necessary, leads project for the region or globally Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. Assist in development of Regulatory Affairs Specialists and other operational area staff, as required Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions. Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval Provides ICH GCP guidance, advice and training to internal and external clients Serve as representative of Global Regulatory Affairs at business development meetings Qualifications: Minimum Required: Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline Computer literacy (MS Office/ Office 365) Fluent in English Preferred: Graduate, postgraduate Possesses basic understanding of financial management Other Required: 5 + years or more relevant regulatory affairs experience Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones Specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development Availability for domestic and international travel including overnight stays Competencies Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment Motivates other members of the project team to meet timelines and project goals Flexible attitude with respect to work assignments, and new learning Resolves project related problems and prioritize workload to meet deadlines with little support from management Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective Collects data of consistently high standard Communicates both verbally and in written form in an acceptable manner Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency #LI-Remote Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$106,000-$151,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
    $106k-151k yearly Auto-Apply 17d ago
  • Safety Lead

    Precision for Medicine 4.6company rating

    Remote Precision for Medicine job

    Responsibilities will include but may not be limited to; project specific teleconferences/meetings (i.e. Kick off meetings, internal study specific meetings, client governance meetings) Safety budget review and approval as needed, safety management plan development, oversight of serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel. Essential functions of the job include but are not limited to: Interfacing with sponsors, vendors, and other internal team members in the area of safety/PV to assist in the design and implementation of safety collection tools, processes, and reporting systems. Participate in the assessment and set-up of a safety database to capture SAE data. QC of documents and safety reports when needed. Preparation and/or review of project specific safety reporting plans and medical coding plans Preparation and/or review of safety training materials Review of Safety related budget tasks and activities Develop and manage standard operating procedures and work instructions. Serve as subject matter expert for department. Provide ongoing training and mentorship for Safety Specialists Participate in audits and audit preparation, kick-off meetings, and investigator meetings. Participate in the CAPA management process. Participate in bid defenses for existing and potential clients. Assist departmental management with resource management. Assist departmental management with oversight. Serve as project manager for safety standalone projects. Lead departmental initiatives and cross-functional development activities. Support the generation of SAE/AESI queries and tracking including oversight in the query resolution escalation efforts. Provide input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities. Assist clients and/or other departmental staff with safety-related reviews and other services. Qualifications: Minimum Required: BA/BS degree 10+ years clinical safety experience 5+ years Pharmacovigilance (PV) experience Other Requirements: Health care professional Hands on experience with global safety database(s), SAE case processing, and safety reports generation Working knowledge of MedDRA and WHODrug Working knowledge of FDA safety regulations, ICH guidelines, and Global regulations Demonstrated knowledge of relevant regulatory agency(s) guidelines governing both Safety reporting and processing for clinical trial environments. Demonstrated knowledge of supporting internal audits, inspection readiness and regulatory agency(s) inspection support for clinical trials including BLA or NDA approval inspections. Excellent communication and analytical skills (written and oral). Excellent judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way. Ability to work in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Preferred: Nursing or pharmacy degree Industry experience in CRO or pharmaceutical company Project management experience Eudravigilance registration experience Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$110,700-$166,100 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
    $41k-77k yearly est. Auto-Apply 13d ago
  • Sr. Executive Assistant II

    Navitus 4.7company rating

    Remote job

    Company Navitus About Us Navitus - Putting People First in Pharmacy - Navitus was founded as an alternative to traditional pharmacy benefit manager (PBM) models. We are committed to removing cost from the drug supply chain to make medications more affordable for the people who need them. At Navitus, our team members work in an environment that celebrates diversity, fosters creativity and encourages growth. We welcome new ideas and share a passion for excellent service to our customers and each other._____________________________________________________________________________________________________________________________________________________________________________________________________________. Current associates must use SSO login option at ************************************ to be considered for internal opportunities. Pay Range USD $69,000.00 - USD $80,000.00 /Yr. STAR Bonus % (At Risk Maximum) 5.00 - Salaried Non-Management except pharmacists Work Schedule Description (e.g. M-F 8am to 5pm) Standard work hours of 8am to 5pm central, with additional work as business needs require. Remote Work Notification ATTENTION: Navitus is unable to offer remote work to residents of Alaska, Hawaii, Maine, Mississippi, New Hampshire, New Mexico, North Dakota, Rhode Island, South Carolina, South Dakota, West Virginia, and Wyoming. Overview The Sr. Executive Assistant II will be responsible for executive level administrative support to the Vice President or Senior Vice President(s) within Navitus. The position requires excellent administrative and organizational skills, handling of the highest level of confidential information, and good public relations. This individual will exercise discretionary powers and independent judgment that directly support management activities daily and perform tasks under only general supervision. Is this you? Find out more below! Responsibilities How do I make an impact on my team? Support the VP or SVP(s) with schedules, telephone, email, filing and document organization, meeting preparation and follow up Prepare presentations, presentation slides and documents, and presentation support materials Maintain positive communications and rapport throughout the organization Assist VP or SVP(s) in ensuring enterprise-wide adherence to policies, procedures, compliance regulations, and other processes Assist all management and employees as a resource in areas of responsibility Organize and maintain a central corporate repository of documents and files Deal with multiple tasks daily, including prioritization and successful execution/resolution Prepare agenda and compile minutes as required for leadership meetings Conduct projects and participate in team activities to identify problems and improve work processes and systems Other duties as assigned Qualifications What our team expects from you? Minimum of High School Diploma or GED with at least eight years of related work experience or a bachelor's degree with at least three years of related work experience Experience in a corporate pharmacy, health care, or insurance setting preferred PowerPoint, Word, Excel software proficiency required Must be well organized, dedicated to quality, service oriented, and possess the ability to analyze and implement process improvements Participate in, adhere to, and support compliance program objectives The ability to consistently interact cooperatively and respectfully with other employees Location : Address Remote Location : Country US
    $69k-80k yearly Auto-Apply 10d ago
  • 2nd Shift Packaging Technician

    Pharmaceutics International Inc. 4.5company rating

    Huntingtown, MD job

    As a Pharmaceutical Packaging Technician, you will be responsible for packaging a range of pharmaceutical products for clinical and commercial use. You will operate, set up, maintain, and clean equipment while following established standardized procedures. Additionally, you will thoroughly document production efforts to ensure compliance with regulatory guidelines. Responsibilities: Performs assigned duties as outlined in the SOPs for packaging of pharmaceutical products according to written instructions from Packaging Labeling records with assistance from a trained packaging technician. Under the guidance of a junior or senior packaging technician, assists in the setup, operation, disassembly, and monitoring of packaging equipment per specifications or packaging instructions for solid, semi-solid, and liquid dosage forms. Assists in performing cleaning procedures on packaging equipment and areas using written procedures, cleaning solutions, and materials under the guidance of a trained packaging technician. Notifies Management of any observed cGMP violations encountered during the performance of job duties and responsibilities. Follows all safety procedures within the cGMP packaging areas and reports all discrepancies to management immediately. Ensures the work area is neat, clean, and orderly by end of the shift. Enhance organizational reputation by striving to meet and exceed performance expectations. Work cooperatively with Quality Assurance and other internal departments to ensure appropriate coordination of manufacturing activities. Maintain job knowledge and training current to ensure compliance in all activities. To identify, investigate, participate in, and take ownership of compliance issues and deviations when discovered. Support the identification and implementation of corrective and preventive actions (CAPAs). Perform other duties as assigned. Qualifications: HS/ GED required with a minimum of 18 months experience as a Junior Packaging Technician within Pii or a minimum of 3 years in the pharmaceutical, cosmetic, or food industry, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities. Ability to add, subtract, multiply and divide all in units of measure, using whole numbers, common fractions and decimals, and percentages. Must have the ability to learn the metric system, weight, and volume measurements. Mechanically inclined; reads and interprets equipment and process documents; follows operating instructions. Exhibits objectivity and openness to others' views. Takes personal accountability for contributions to the team and organizational results. Demonstrated accuracy and thoroughness; looks for ways to improve and promote quality. Consistently checks all documents for errors and constantly strives for right the first time mentality. Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates. Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision. Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required. Must be able to comprehend and follow all applicable SOPs. Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise. Demonstrate ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products. Good understanding of cGMPs, industry, and regulatory standards and guidelines. Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc. Demonstrate the ability to portray the appropriate level of integrity and professionalism. Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats. Demonstrate the ability to complete tasks accurately and according to established and shifting timelines. Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions. Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment. Results-oriented and efficient. Creative and open-minded who fosters an environment in which sharing of ideas is encouraged. Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally). Demonstrate the ability to work well in a cross-functional team environment. Must communicate fluently in English and have legible handwriting. Physical Demands: Ability to travel between and within facilities to visit staff, operations, and projects, as needed. Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary). Ability to lift up to 40 pounds on occasion. Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
    $33k-43k yearly est. Auto-Apply 60d+ ago
  • Senior Field Specialist, Clinical Research (Remote/National Travel)

    Cordis 4.2company rating

    Remote or Irvine, CA job

    Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. **Responsibilities** The **Field Specialist, Clinical Research** position that provides case support to physicians within a given territory. Case support provided on peripheral and coronary interventional procedures in pre-market and post-market phases of product development with SELUTION-SLR. The CFS plays a critical role in clinical studies including device training, case support and ensuring timely data collection for clinical programs. **Job Functions:** + Perform Physician and hospital staff training and procedural case coverage to ensure safe and effective use of the device + Present clinical study training materials based on investigational plans including study protocol, IFU, core lab manuals and case report forms + Provide field support for clinical studies by participating in site selection, site initiation and activation, supporting cases, ensuring quality data acquisition throughout follow up and performing study closure activities + Address clinical research site needs by maintaining frequent contact via email/phone/on-site visits with PI's and research coordinators + Responsible for gaining and maintaining knowledge of clinical sites in a given geographical area to best understand and assess investigators interests and capabilities + Manage key study sites (investigators and research staff) and serve as 'live' point of contact with the site for communication with SELUTION CSM, CRA, and CRO team + Partner with SELUTION clinical research teammates to meet business needs in the field including site CIP questions, re-training, case coverage, data entry/query resolution and escalation of critical issues + Administrative activities including evaluating metrics, data entry into trackers, documentation of activities and site feedback to SELUTION study teams + Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines and policies + Identify and mitigate quality risks and issues for assigned clinical studies with oversight from study management team + Assist with oversight of activities performed by CRO + Maintain in-depth knowledge of current study protocols, process and procedures to assist sites and facilitate study management team efforts **Role Expectations:** + Ability to travel **75%+** within designated geographic territory to facilitate on-site visits to assigned clinical sites + Be available to cross-cover sites as back up for other CFS territories, including holding necessary credentialing + Attend and lead SIV and site activation activities at assigned sites (in-person priority) for duration of the event + Attend start-up phase enrollments and clinical follow up visits at each assigned site to ensure site protocol compliance, image upload and readability and quality data collection Prioritize regular communication with study management team and CRO **Qualifications** Qualifications + Ability to travel **75%+** within designated geographic territory + Bachelor's Degree in life sciences, nursing, engineering, or healthcare related field (preferred) + Minimum 3 years' experience with cardiovascular procedures in clinical research in this same role or as a nurse or tech as radiology tech or Cath lab tech + Minimum 3 years' experience working directly with physicians and healthcare professionals + Prior experience with clinical trials (preferred) + Experience in coronary or peripheral interventions + Ability to travel (at least 75%) to company and clinical trial sites Pay / Compensation The expected pre-tax pay rate for this position is $76,450 - $145,000 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location. US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa. **Preferred Qualifications** Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one-s identity. All our teammate-s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming. **JOIN OUR TALENT COMMUNITY** Joining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you! Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests. **Job Locations** _US-CA-Irvine_ **ID** _2025-12332_ **Category** _Clinical_ **Position Type** _Regular Full-Time_ CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact *******************
    $76.5k-145k yearly 25d ago
  • Manager, LMS Administration and Operations (Princeton, Hybrid)

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Remote or Phoenix, AZ job

    The Manager, LMS Operations & Administration position works as part of the U.S. Ethics & Compliance Training & Documentation team to lead all components of our Learning Management System (LMS) including all non-GxP assignments and audience management, curriculum management, reporting, and tier one trouble shooting. The Manager, LMS Operations & Administration will partner with all levels of Management in both business and technology groups to advance and deliver a variety of planned and ad-hoc training initiatives. This position will have direct oversight of two Contracted Workers. **** + Responsible for the operational oversight of all LMS activities including but not limited to: + Partner with internal LMS Support Team to perform needs assessments and analysis on platform operations to ensure organizational needs are being met. Leads the incorporation, socialization, and training of resulting LMS improvements. + Owns all non-GxP LMS usage workflows and processes with business owners for suitability/fit; suggests and implements alternatives as needed + Regularly perform reviews of existing training curricula, identify gaps in course assignments and implement necessary changes. + Create, maintain, and run scheduled as well as custom reports, in a timely manner, as designated for analysis and decision making. Create new reports as requested. + Assist in managing external vendors, suppliers, and internal business partners as needed with a continuous improvement mindset. + Partner across departments as necessary to initiate timely and compliant learning initiatives + Continually enhance our methods and materials based on best practices in the industry, emerging technologies, vendor resources and products, business unit requirements and expectations, and feedback from customers, trainers and associates. + Ensure operational alignment across OAPI/OPDC learning community + Develop and deliver LMS platform training when required. + Oversee the work of two remote-based contracted resources. + Represent Field Training and Development's unique needs at governance and committee meetings/working groups **Qualifications/ Required** Knowledge/ Experience and Skills: + Bachelors degree in related field, or equivalent experience and demonstrated skills and abilities + 5+ years of Learning Management System (LMS) experience + Advanced working knowledge of LearnShare LMS + Understanding of current approaches in applying technology in learning solutions and experience implementing e-Learning and web-based programs. + Strong technical acumen; proficiency in Microsoft Office 365, SCORM; experience with Tin Can/xAPI, LRS's, and general technical troubleshooting + Ability to work in a fast-paced environment and be comfortable with consistent change + Detail-oriented with strong organizational skills + Strong written and verbal communication skills + Ability to prioritize and manage multiple responsibilities at once + Positive can-do attitude; always willing to learn + Strong analytical/technical skills + Comfortable with data management/data manipulation + Resiliency and tolerance of ambiguity **Preferred:** + Experience in pharmaceuticals/medical devices or other regulated industry + Embody a customer service mentality as you communicate and support field sales teams + Experience leading Contract Workers remotely Educational Qualifications + Bachelors degree in related field, or equivalent experience and demonstrated skills and abilities **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $104,640.00 - Maximum $156,400.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $104.6k yearly 14d ago
  • Scientist III - (HPLC) Chromatography - Separations & Molecular Biology - Immunoassay Experience - FSP

    Parexel 4.5company rating

    Annapolis, MD job

    We are looking to fill a **Scientist III - (HPLC) Chromatography - Separations & Molecular Biology - Immunoassay Experience** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer any sponsorship.** **Description** Support of routine bioanalytical testing of samples from cell-line development, in-process, process development/characterization, forced degradation, release & stability, and pre-formulation. Other potential opportunities include method development/optimization, workflow optimization, and template development. **Responsibilities** + Support of high-throughput, pre-formulation, pre-qualification, robustness, or admixture testing + Results processing and documentation by following appropriate methods / protocols / procedures + Sample management and monitoring of controlled temperature units. + Following all appropriate laboratory safety and hygiene procedures **Qualifications** + BA/BS (3-5 yrs.) of relevant experience in analytical chemistry or biologics testing lab + MS (1-2 yrs.) of relevant experience in analytical chemistry or biologics testing lab **Required Skills and Experience** + Must have separations experience for large molecules or plate-based assay experience. + Experience in analyzing biologics including monoclonal antibodies and/or other therapeutic proteins using at least one of the following techniques: + Liquid Chromatography (HPLC / UPLC) + Protein A Titer, Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX, AEX, CEX), Reverse Phase (RP), or Hydrophobic interaction chromatography (HIC) + Electrophoretic methods such as capillary electrophoresis sodium dodecyl sulfate (CE-SDS) and/or capillary isoelectric focusing (cIEF) + ELISA (HCP, proA) and binding potency assay + qPCR and basic molecular biology techniques (gel electrophoresis, etc.) + High-throughput liquid handling system, e.g., Tecan, Bravo, etc. + Basic instrumentation troubleshooting + **Ability and willingness to train in molecular biology and immunoassay testing** + **Familiarity with Microsoft Office Applications (Outlook, Excel, Word, PowerPoint, OneNote, Teams, etc.)** **Desired Skills and Experience** + Familiarity with compendial testing such as UV 280, pH, and Physical Observations + **Ability to follow complicated scientific protocols / procedures** + Making accurate reagent preparations (dilutions / solutions / buffers / mobile phases) + Good documentation practices & utilization in electronic lab notebooks (ELN) + Analytical software such as Empower. + Knowledge of Laboratory Information Management Systems (LIMS) + Sample submission & sample management + Monitoring of controlled temperature units + Experience with BSL2 (Biosafety Level 2) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
    $88k-127k yearly est. 46d ago
  • Cagewash Attendant I (14BS)

    Charles River Laboratories 4.3company rating

    Bethesda, MD job

    For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. **Job Summary** We are seeking a Cagewash Attendant I to join our Insourcing Solutions team located in Bethesda, MD. As the Cagewash Attendant I, you will sanitize, maintain and repair animal cagewash materials. Additional responsibilities include: + Follow SOPs and quality assurance standards + Perform routine preventative maintenance on cagewash and autoclaves + Maintain animal holding facilities clean and organized + Other tasks may include assist with receipt, stocking and maintenance of inventory supplies + Become involved in animal care and husbandry of multiple animal species **Job Qualifications** The following are minimum requirements related to the Cagewash Attendant I position: + High school diploma or GED preferred + Knowledge of detergent/disinfectant and operating knowledge of sanitization and sterilization equipment + Cagewash experience preferred + Must be successful in obtaining the ALAT (Assistant Lab Animal Technician) Certification within 1 year of eligibility. The pay for this position is $18.50 USD per hour. Schedule: Monday through Friday 7AM-3:30PM. **About Insourcing Solutions** Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. **About Charles River** Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. **Equal Employment Opportunity** Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 231067
    $18.5 hourly Easy Apply 7d ago
  • Account Supervisor - Market Access Marketing

    Precision Medicine Group 4.1company rating

    Remote job

    Precision AQ - Market Access Marketing, is the top payer marketing agency in the country. We partner with global pharmaceutical and life sciences companies who are developing groundbreaking treatments to make medicines accessible and affordable. We excel at demonstrating the economic, clinical, and societal value of creative medical treatments to payers, providers, patients, and policymakers. At Precision, we will recognize your achievements and contributions. You will have the opportunity to learn from external training, provide mentorship, and work with cross-functional project teams. Plus, our advancement opportunities will allow you to realize your full potential. The Account Supervisor functions as a team leader and provides support through overseeing and coordination of projects. The Account Supervisor is responsible for assuring and maintaining client satisfaction as the primary client point of contact. The Account Supervisor serves as a liaison between client services leadership, strategy, and internal operations and is responsible for the success and profitability of all support projects. Essential duties include but are not limited to: Client Management: Assume primary lead for the client upon client acceptance of proposal Maintain and manage business opportunities with existing clients Development of client agendas and slide presentations Lead and/or support calls with client and LMR, faculty, and/or content experts regarding content and direction Review and forward status/contact reports to client after each client contact Develop project briefs and scope of work for clients and internal team members. Project Management: Provide direction to support team on all aspects of project management to ensure client expectations are met or exceeded Manage projects by utilizing approved internal project briefs, proposal templates, and budget tools Collaborate with internal team on overall project plan, objectives, milestones, and deliverables Leadership: Function as internal team leader ensuring all members of the team work together smoothly and effectively Mentor personnel at the Associate Account Executive, Account Executive, and/or Senior Account Executive levels. Depending on size of team, potential for management and supervision of colleagues. Conduct performance reviews, prepare development plan, and set goals for direct reports as applicable. Must be able to execute and teach junior level Account team employees the following: development of client agendas, project status, financial reports, and contact report Business Development: Work with Client Services leadership and Strategy to help identify market opportunities that will further client business Identify opportunities for organic growth within assigned accounts Finance: Develop proposals, budgets, and reconciliations Collaborate with all teams to ensure proposal development is accurate and all teams hours are captured (Traffic, Production, Creative, Clinical/Copy, Meeting Services, etc) Monitor budgets including direct costs, labor costs, fee, and out-of-pocket expenses to ensure team members/direct reports are managing assigned budgeted labor hours and direct costs Provide periodic budget status updates and communication with client Additional Accountabilities/Responsibilities: Ability to work central time hours Adheres to PhRMA, FDA, OIG and ACCME guidelines Demonstrate ownership and accountability for all agency procedures and workflow Attend internal meetings with Sales, Client Services, Meeting Services, Traffic and other key personnel to discuss project status as required Ensure the highest standards of quality control of client materials and, as appropriate, develop best practices protocols for internal project teams to facilitate quality control Contribute original ideas for tactical planning within assigned accounts Qualifications: Minimum Required: Education: Bachelor's degree in marketing, advertising, communications, or related subject Work Experience: At least 3 years in an Account role within a pharmaceutical/medical communications company. Daily client facing experience and Medical, legal, regulatory review experience is required #LI-REMOTE Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$90,000-$123,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
    $90k-123k yearly Auto-Apply 35d ago
  • Repository Specialist I (Sample Management Associate)

    Charles River Laboratories 4.3company rating

    Frederick, MD job

    For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. **Job Summary** We are seeking a **Repository Specialist** for our **Insourcing Solutions** team based at our facility in **Frederick, MD** . As the **Repository Specialist** , you will receive, handle and inventory specimens of human, animal and/or plant origin at temperatures ranging from ambient to -195°C, as well as weigh and prepare samples for pickup, courier delivery and shipment. Additionally, you will be tasked with maintaining repository files for validation of data and preparation of reports, as well as review accumulated data for accuracy and prepare reports of information and sample data. Additional responsibilities include: + Assemble and display data for the storage and retrieval of specimens and for report preparation. + Perform freezer inventories, as well as operate and freeze specimens utilizing controlled-rate freeze equipment. + Participate in temperature/liquid nitrogen (LN2) liquid level monitoring and emergency response rotations. + Process and aliquot specimens. + Enter data into client's online repository database for sample tracking and inventory management. + Driving client vehicle to deliver and pick-up specimens locally. **Job Qualifications** The following are minimum requirements related to the **Repository Specialist** position: + High School Diploma or equivalent + Valid driver's license + A minimum of two years related office and administrative experience preferred + Experience working in a shipping/receiving environment with scientific data preferred An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. The pay for this position is $20.00 per hour. **About Insourcing Solutions** Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. **About Charles River** Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 231136
    $20 hourly Easy Apply 41d ago
  • Linux Admin role

    Pharmatek Consulting 4.0company rating

    Woodlawn, MD job

    Key Required Skills: Red Hat Enterprise Linux 7.x/8.x Platform Administration, experience with virtual platforms, ansible playbooks and scripting languages for automation tasks and deployments. Position Description: • Lead efforts in developing new strategies for operational efficiencies • Lead Automation strategies using Ansible application • Work with applications teams and stakeholders as the platform technical lead • Work with highly experienced and technical resources • Assist technical leads in implementing systems and software updates • Deploy RHEL patches and platform updates • Document processes, procedures and configurations • Perform daily operations support functions, including problem isolation and resolution • Provide status updates of task and project updates • Provide system administration support • Troubleshoot platform and application issues • All other duties as assigned or directed Skills Requirements: FOUNDATION FOR SUCCESS (Basic Qualifications) • Bachelor's Degree and 7+ years of experience in Computer Science, Mathematics, Engineering, or a related field or 11+ years in lieu of a degree. • 7+ years of experience as a Red Hat Enterprise Linux 7.x/8.x Platform Administration (administration, installation, configuration, optimization, backup & recovery) • Excellent interpersonal and communication skills. • Experience with the US Federal Government • Must be able to obtain and maintain a Public Trust. Contract requirement. Requirements FACTORS TO HELP YOU SHINE (Required Skills) These skills will help you succeed in this position: • Solid experience as a Red Hat Enterprise Linux (RHEL) Administrator • 7+ years of experience with performance tuning & troubleshooting, identifying and resolving memory, CPU, access, networking, disk I/O, etc. • 5+ years of experience working Virtual Platforms. • 5+ years of experience working with Ansible Playbooks. • 3 years of experience with scripting languages for automation tasks and deployments (e.g., Bash Shell and Python) • Expertise in the Linux command -line environment • Excellent knowledge and experience with RHEL applications and tools - Ansible, Satellite, etc. • Experience in providing support for installation, configuration and troubleshooting of middleware applications HOW TO STAND OUT FROM THE CROWD (Desired Skills) Showcase your knowledge of modern development through the following experience or skills: • Adept at working independently, but also in a team environment • Demonstrated experience delivering technology solutions in a fast -paced, deadline driven enterprise environment • Excellent understanding of change management, testing requirements, techniques, and tools to ensure high availability of systems • Experience developing and maintaining Red Hat Ansible Playbooks • Prior Federal government experience • Self -starter, highly motivated individual who adapts to a dynamic work environment • Strong attention to detail with an ability to operate effectively across multiple priorities Education: • Bachelor's Degree and 7+ years of experience or 11+ years in lieu of a degree. • Must be able to obtain and maintain a Public Trust. Contract requirement.
    $78k-103k yearly est. 60d+ ago
  • Federal Account Manager- Vaccines

    Sanofi Group 4.3company rating

    Bethesda, MD job

    **Job Title:** Federal Account Manager- Vaccines **About the Job** Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization. **About Sanofi:** We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. **Main Responsibilities:** **Key responsibilities of this role include, but are not limited to:** + Development of long-term strategic relationships with key federal customers including Veterans Administration, Department of Defense, and Indian Health Services to achieve optimal outcomes for patients treated within the Federal systems of care. + Ensure appropriate utilization of the Sanofi Vaccine portfolio of commercial products across federal systems groups at the facility level. + Development and implementation of federal sales strategies across the Sanofi Vaccine portfolio of products to grow sales and increase local coverage + Coordinate initiatives and drive sales in federal accounts partnering with brand & health system marketing, contracting, analytics, and sales teams across the Sanofi Vaccine portfolio of products. + Optimizing product access while reducing barriers confronting Sanofi Vaccine product portfolio. + Enhancing key business relationships at high priority VA Medical Centers (VAMCs), MTFs and IHS facilities including tribal nations + Assist in market development and conditioning of Federal customers specific to the vaccine portfolio **About You** **Requirements** + At least 5 years of successful US Federal Account management experience + Seasoned Federal Accounts leader with life sciences experience + Proven past success in the US federal segments of VA, DHA and IHS + Deep established relationships with key federal leaders + Demonstrated skills in business planning and strategy development with strong problem-solving skills + Strong communicator with the ability to influence others + Ability to translate and compile data into comprehensive and functional reports leading to actionable outcomes + Highly organized and detail oriented with excellent written and oral communication skills + Ability to travel as required for customer engagement, conferences, and internal meetings up to 75% + Candidates must be flexible, possess positive mindsets, work with a high sense of urgency, and excel at collaboration with peers + Knowledge of Federal procurement methods. (GPS, FSS, DOD, etc.) **Education** + Bachelor's Degree required **Preference** + Veteran or retired military with military ID (DOD-CAC) card (retired, reserve, guard, or retired spouse) to access military installations. **Why Choose Us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. This position is eligible for a company car through the Company's FLEET program. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. LI-SP \#LI-Remote \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $122,250.00 - $176,583.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************
    $122.3k-176.6k yearly 18d ago
  • Flow Cytometry Scientist

    Precision for Medicine 4.6company rating

    Precision for Medicine job in Frederick, MD

    Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages-from early development through approval-with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Participate in flow cytometry projects through assay development, validation, and execution in a timely manner. Perform assays according to SOPs and support development of new procedures and improvement of existing SOPs. May perform other cell based assays. Essential functions of the job include but are not limited to: Perform Flow cytometry primarily, as well as, other immune assays Design and perform experiments, independently and accurately analyze and present data High quality output is essential with the ability to build efficiency into improving productivity metrics Assist in establishing and improving all procedures and required SOP documentation Responsible for trouble shooting and correcting routine scientific issues/problems Identify, update and implement emerging laboratory techniques Maintain and support safe lab practices and environment Work collaboratively with other technical teams in resource sharing and providing technical expertise Support new equipment operational qualifications and performance checks Monitor Product and Service/R&D related project expenses Act as a scientific resource externally to clients and internally Assists with writing, reviewing and editing contract and grant applications/proposals as appropriate. Assists with writing and publishing papers, abstracts, techniques/or chapters to maintain the scientific standard and image of the company May present completed work at appropriate scientific meetings and in publications Other duties as assigned Qualifications: Minimum Required: Master's Degree in life sciences or other relevant field 5 years of relevant laboratory experience Other Required: Expert level flow cytometry skills using both whole blood and isolated cells Demonstrated skills in monitoring cell-mediated immunity through flow cytometry, as well as, ELISpot, ELISA and MSD Excellent communication, interpersonal, and organizational skills required Must have the ability to organize and analyze data, as well as, prepare reports Must possess strong computational skills, preferably experienced with Word, Excel, Power Point, GraphPad Prism, Diva, and FlowJo Excellent use of judgment and discretion required Extended work hours may be occasionally necessary in order to meet business demands The ability to see and differentiate between colors on the full color spectrum Ability to lift and carry between 1-15 lbs.; Ability to lift up to 50 lbs. overhead with assistance; frequently required to sit, grasp, and use right/left finger dexterity; May be exposed to a cold freezer environment (Freezer temperatures range between -20ºC -196ºC) Must be able to read, write, speak fluently and comprehend the English language Preferred: A solid understanding of current GLP or CAP/CLIA/ISO standards Demonstrated skills with assays used for immunophenotyping such as primary cell based assays, ELISpot, ELISA and Mesoscale Experience with cell sorting techniques Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
    $71k-105k yearly est. Auto-Apply 35d ago
  • Inventory Specialist

    Knipper 4.5company rating

    Bel Air South, MD job

    THIS IS A PART-TIME/CASUAL OPPORTUNITY. THE NUMBER OF HOURS PER WEEK WILL VARY. This position is responsible for performing audits of client inventories, storage site inspections and inventory closeouts. J. Knipper and Company and KnippeRx are Equal Opportunity Employers Responsibilities KEY RESPONSIBILITIES: Conduct audits of client inventories at client specified storage site. Follow client business rules, finalize necessary reconciliation(s), and complete required documentation. Complete all assignments in a professional and timely manner in accordance with Company and Client business rules. Submit all assignment status changes using the on-line Audit Inventory Management System (AIMS). Review all instructions and forms required to complete assignments prior to audit to ensure quality service levels. Ensure that assignments are scheduled in accordance within Client expectations and timelines Communicate with client representatives and AIMS management team via email, US mail, and/or phone. *The above duties are meant to be representative of the position and not all-inclusive. Other Responsibilities: Ability to utilize smartphone to update AIMS and complete assignments. Follow all department and company policies and procedures. Strive to exceed client needs. Communicate clearly and professionally in email and phone calls. Qualifications MINIMUM JOB REQUIREMENTS: Education/Training: High School Diploma or GED Required College Degree Preferred Must have mobile electronic device. Must have transportation to audit sites. If driving a motor vehicle, must have valid driver's license with records that satisfy Company standards as well as current motor vehicle insurance. Related Experience: Pharmaceutical industry and/ or Pharmaceutical Sales experience preferred. Knowledge, Skills, and Abilities: Strong communication skills, intermediate math skills, attention to detail, and computer skills Physical Requirements: May be required to bend, squat, kneel, or stand for long periods. May be required to lift up to 25 lbs. periodically Reasonable accommodations may be made to enable individuals with disabilities to perform the essential responsibilities of this job.
    $29k-47k yearly est. Auto-Apply 60d+ ago
  • Join Our Talent Community - Manager, Account Development

    Precision for Medicine 4.6company rating

    Remote Precision for Medicine job

    Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages-from early development through approval-with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won't you join us today as a Manager, Account Development? The focus of the Manager, Account Development is to increase market awareness, generate leads, and increase customer base for the Business Development Team. This is achieved by a high degree of direct contact with prospective clients including by telephone, by email and direct mail. The duties also include assisting in developing and implementing strategies to facilitate long term relationship with new and existing clients. The Manager, Account Development will also work closely with the Business Development Leadership Team to establish and help implement and confirm “inside sales” best practices based on prior experience, available technologies and aligned to company goals. Essential functions of the job include but are not limited to: Review current account development processes, messaging & technologies and recommend areas for improvement Assist in establishing account development production expectations and metrics aligned to corporate goals Collaborate with Business Development Leadership Team for performance review, mentoring and development Hold weekly territory outreach planning calls with assigned BD on newly identified Tier 2 Accounts. Identify well aligned potential clients and contacts using defined “ideal account” profiles by using Citeline, ZoomInfo, LinkedIn Sales Navigator and other news resources as triggers for new based outreach Identify key stakeholders/decision makers and introduce differentiators and capabilities resulting in opportunities to participate in the request for proposal and bid process. Using activity and results data create improved outreach messaging in an effort to increase client response and interactivity Develop and deploy territory and account strategies that incorporate significant account and industry profiling with pipeline and therapeutic content. Initiates sales process by communication (call, emails or direct mail), understanding prospective client requirements, introducing services that address their needs and engaging Business Development with prospective clients when ready for face-to-face meetings. Set-up meetings for BD representatives: regionally and at conferences etc. in coordination with Marketing department Provide weekly, monthly and quarterly sales activity reports to review with Line Manager and Business Development executives. Ensure all activity is recorded in Salesforce and HubSpot appropriately. Mentor & train new members in the Inside Sales team. Collaborate with appointed Business Development Mentor to develop Other duties as assigned. (as discussed work with BD when appropriate on proposals to progress developing career towards BD). Working Relationships: Reports to the Business Development Leadership Team. Collaborates closely with global Business Development Team Liaises with all internal stakeholders within Contracts & Proposals, Clinical Operations and Marketing. Collaborates closely with Inside Sales members Ability to identify process efficiencies and make recommendations for improvement Qualifications: Minimum Required: Bachelors, or equivalent level of experience, ideally in a business, scientific or healthcare discipline Full Professional Proficiency in English Other Required: 5 years or more in the CRO/pharmaceutical industry Availability for occasional domestic and international travel including overnight stays Preferred: Account development and sales experience Postgraduate Skills: Competencies Possesses a keen understanding of the Oncology and Rare Disease Development market and the role that Precision for Medicine plays in that environment Resolves company and client related problems and prioritize workload to meet deadlines with little support from management Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment Motivates other members of the company to meet timelines and company goals Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective Demonstrates a high degree of professionalism, as evidenced by ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills in the areas of diplomacy and negotiation Communicates both verbally and in written form in an exemplary manner Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency Possesses practical knowledge of IT tools and systems in use in the company and on the project teams Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
    $64k-112k yearly est. Auto-Apply 35d ago
  • Project Leadership - Biotech (Clinical Trials) - Obesity / Diabetes - Home Based (Future Needs)

    Parexel International 4.5company rating

    Remote job

    When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve. Parexel's defined Biotech Division offers opportunities for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group focuses specifically on Biotech clients and providing all areas of support to accommodate their unique needs. This is a great opportunity for those in the industry who prefer the flexibility, creatively and problem-solving mindset to successfully support this type of clients. Parexel has upcoming future opportunities at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading obesity global studies. Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior role of Senior Project Leader. To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
    $98k-139k yearly est. Auto-Apply 4d ago
  • Manager, HCP Engagement

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Annapolis, MD job

    The Manager, HCP Engagement Lead is a dedicated execution role responsible for the day-to-day operation and administration of the R&D Healthcare Professional (HCP) engagement and contracting process. This position is the primary point of contact for internal stakeholders seeking to engage external experts and is accountable for ensuring all contracts, payments, and documentation are processed efficiently, compliantly, and in accordance with the CoE's established "white glove" service standards. This role supports the Associate Director in maintaining the integrity of the centralized system and achieving audit-readiness. This position reports directly to the Associate Director, R&D HCP Engagement Center of Excellence (CoE). **** **Key Responsibilities Include:** **Operational Execution and Contract Management** + Execute the end-to-end HCP contracting workflow, including drafting agreements, securing internal approvals, and managing signature processes using the centralized system (e.g., iHub/Veeva) + Process all HCP payments and expense reimbursements accurately and in a timely manner, adhering strictly to fair market value (FMV) determinations and financial compliance standards + Serve as the primary operational point of contact for internal R&D stakeholders (GMA, Clinical) and external HCPs regarding contract status, payment inquiries, and logistics + Oversee the consistent input and maintenance of all HCP contract and engagement data within the centralized system to ensure a single source of truth + Monitor and support the HCP engagement process, ensuring accurate tracking of activities and assisting in the identification and resolution of operational bottlenecks in collaboration with the Associate Director. **Service Excellence and Compliance Support** + Implement the "white glove" service standards set by the Associate Director, ensuring professional, timely, and consistent communication with external experts to provide a smooth and effortless engagement experience + Triage and address immediate HCP feedback and complaints regarding the engagement process, escalating systemic issues to the Associate Director for strategic resolution + Maintain meticulous documentation and record-keeping for all HCP contracts and interactions to ensure the CoE is fully prepared for internal and external audits + Support the Associate Director in monitoring for KOL fatigue and contract thresholds by actively tracking expert engagement frequency **Data and Metrics Support** + Support the Associate Director in the development and routine generation of performance dashboards and KPIs related to contracting cycle time, payment processing, and operational efficiency + Extract and prepare engagement/contracting data for analysis to help identify trends, bottlenecks, and opportunities for process optimization + Utilize technology and the centralized system to support the tracking of all required compliance metrics + Support the identification of process improvement opportunities within the CoE, and contribute to the implementation of innovative solutions including technology and AI tools to enhance workflows across Medical Affairs and R&D + Support the identification of process inefficiencies by gathering operational data and assisting in the implementation of scalable, automated solutions to reduce cycle times and administrative burden. + Participate in cross-functional Root Cause Analysis (RCA) efforts, documenting findings and contributing to the execution of corrective and preventive action (CAPA) plans under the guidance of the lead. **Qualifications** **Education and Experience:** + Bachelor's degree in Business Administration, Life Sciences, Finance, or a related field is required + Minimum of 5 years of hands-on experience in pharmaceutical or biotechnology operations, with direct experience in HCP contracting, finance operations, or compliance + Proven proficiency in using iHub or similar contract/CRM management platforms for data entry, workflow management, and contract processing. Strong foundational knowledge of global compliance requirements related to HCP engagement, including FMV, transparency reporting, and anti-bribery regulations. **Skills and Competencies:** + Strong project management and organizational skills + Demonstrated in-depth understanding of HCP compliance frameworks and reporting requirements + Deep understanding of HCP engagement processes and compliance frameworks, with knowledge of global transparency, FMV, and reporting requirements + Proven track record of proactive, entrepreneurial work style + Excellent communication, presentation and collaboration skills + High attention to detail, accuracy, and documentation standard + Proficient with Excel, PowerPoint, and CRM/engagement tracking tools + Strong interpersonal skills with ability to manage multiple cross-functional stakeholders **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $104,640.00 - Maximum $156,400.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $104.6k yearly 14d ago
  • Director, Manufacturing Platform Technology - Global Tech Ops

    Astrazeneca 4.6company rating

    Gaithersburg, MD job

    Job Title: Director, Manufacturing Platform Technology - Global Tech OpsLocation: Gaithersburg, MD Hybrid working ~ 3 days per week in the office location Introduction to role Are you ready to lead the charge in transforming AstraZeneca's manufacturing capabilities for 2030 and beyond? As the Director of Manufacturing Platform Technology, you'll be at the forefront of change, driving platform establishment across the enterprise! The GTO Platform Lead represents a strategic cross-functional leadership role within Biologics Operations and Global Technical Operations. This position encompasses the leadership and development of a diverse, cross-functional team whilst maintaining primary accountability for strategic planning, coordination of technical leadership initiatives, and the provision of comprehensive operational support to our global technical network and key customer partnerships. Join us in shaping the future of manufacturing technology and equipment platforms across biologics and new modalities! Key Accountabilities: Lead a matrixed, cross-functional team to shape and scale AstraZeneca's manufacturing technology/equipment platforms across biologics and new modalities. Partner closely with Development, Operations, Quality, Regulatory, and external manufacturers to deliver robust, flexible, and inspection-ready platforms. Enterprise impact: Set the platform vision, standards, and roadmap; accelerate continuous manufacturing adoption; harmonize ways of working across internal sites and CMOs to improve speed, reliability, and cost to serve. Platform strategy and standards: Technology/Equipment Operating envelopes: Define highs/lows, critical process parameters, and control strategies for each unit operation. Templates and playbooks: Publish platform process descriptions, tech transfer playbooks, and manufacturing technology standards that teams can use globally. Change agility: Build comparability and “switch” strategies into equipment platforms to manage lifecycle changes with minimal disruption. Modalities in scope: Core: Fed-batch, intensified, microbial fermentation, and continuous mammalian bioprocessing Emerging: Nucleic acid therapies, Antibody drug conjugates, radioconjugates, viral and gene therapies, enzyme-produced biologics, protozoan fermentation Continuous manufacturing leadership: Vision and adoption: Set enterprise standards and the adoption plan for end-to-end continuous processing. Design and control: Define PAT/APC, residence-time distribution, steady-state verification, and start-up/shutdown strategies that meet global regulatory expectations. Scale-up and launch: Guide piloting through commercial implementation; quantify business value and embed learnings across the network. Collaboration and matrix leadership: Co-create with partners: Work hand-in-hand with CMC, Clinical, Regulatory, QA, and site leaders to align on risk, control, and lifecycle strategies. Network integration: Harmonize processes and capabilities across internal sites, CMOs, and acquisitions; establish clear governance, roles, and accountability. Transparent communication: Maintain timely updates, risk escalation, and portfolio alignment across Global Tech Ops and Biologics leadership. Technology and site enablement: Site readiness: Working closely with tech transfer leads, Stand up technology transfers to site, define ways of working, and embed digital tools for monitoring and decision-making. Technology Readiness: Acting along with current site leads, or in lieu of local MS&T for new sites, Regulatory partnership: Authoring and strategy: Co-author technical content for design control strategies that enable post-approval flexibility. Engagement and inspection: Prepare teams and sites for regulatory interactions and inspections. Data-driven improvement: Data and Process Standardization: Collaborating across the enterprise, establish standards for process data and information needed to support autonomous decision making. Performance management: Define metrics and scorecards; use feedback loops to track adoption and impact. What Success Looks Like in This Role Standardisation and Speed You will establish reusable platform standards that dramatically reduce development and technology transfer timelines, enabling faster delivery of life-changing medicines to patients. Your work will create scalable frameworks that eliminate redundancy and accelerate innovation across our manufacturing operations. Continuous Adoption Leadership Drive the scaled implementation of continuous manufacturing processes, delivering measurable improvements in operational robustness, cost efficiency, and sustainability performance. You will champion pioneering manufacturing technologies that position AstraZeneca at the forefront of pharmaceutical innovation. Network Alignment Excellence Establish consistent ways of working across all manufacturing sites and Contract Manufacturing Organisations (CMOs), implementing clear governance structures that ensure seamless collaboration and operational excellence throughout our global network. Operational Impact Delivery Your initiatives will directly contribute to higher yields, reduced variability, and accelerated time to clinical and commercial supply, ultimately ensuring patients receive high-quality medicines more quickly and reliably. Essential Skills/Experience Experience: 12 years in biologics manufacturing (or 10+ with an advanced degree); 5+ years in process engineering/development; late-stage and commercial exposure. Continuous manufacturing: Recent, hands-on leadership implementing continuous bioprocessing in a manufacturing setting. Regulatory: Proven authoring of technical sections or leading technical regulatory strategy. Collaboration: Strong record of leading matrix teams and influencing across internal customers and external partners/CMOs. Desirable Skills/Experience Preferred: Site engineering background; validation experience for new modalities/formulations; late-phase nucleic acid manufacturing or analytics; proficiency with Power BI, Power Automate, and Microsoft Office. The annual base salary for this position ranges from $175,572.00 to $263,358.00. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca offers an environment where you can make a positive impact while building a long-term career filled with global opportunities. Our commitment to delivering accelerated growth pushes us to innovate continuously. With a focus on Lean processes, cutting-edge science, digitalization, and sustainable practices, we are dedicated to making people's lives better. Our inclusive community supports each other on our journeys, fostering curiosity and problem-solving. Embrace the chance to broaden your knowledge and skills in a place where your dedication is rewarded. Ready to take on this exciting challenge? Apply now to join us in shaping the future of manufacturing technology at AstraZeneca! Date Posted 18-Dec-2025 Closing Date 30-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.
    $175.6k-263.4k yearly Auto-Apply 2d ago
  • Sales Director - Midmarket

    New Era Technologies Inc. 3.5company rating

    Remote job

    Join New Era Technology, where People First is at the heart of everything we do. With a global team of over 4,500 professionals, we're committed to creating a workplace where everyone feels valued, empowered, and inspired to grow. Our mission is to securely connect people, places, and information with end-to-end technology solutions at scale. At New Era, you'll join a team-oriented culture that prioritizes your personal and professional development. Work alongside industry-certified experts, access continuous training, and enjoy competitive benefits. Driven by values like Community, Integrity, Agility, and Commitment, we nurture our people to deliver exceptional customer service. If you want to make an impact in a supportive, growth-oriented environment, New Era is the place for you. Apply today and help us shape the future of work-together. Include benefits highlights here. Paste full here. Include qualifications here. SUMMARY: New Era Technology Is a trusted global digital systems integration partner, delivering innovative solutions to help clients achieve mission critical business outcomes. We collaborate with our customers across three solution pillars: Digital Transformation - Enabling organizations to modernize applications, optimize business processes, and leverage data-driven innovation. Modern Infrastructure & Workspaces - Designing and delivering resilient, scalable infrastructure and empowering employees with secure, productive digital workspaces. End-to-End Security - Protecting the enterprise across devices, networks, applications, and cloud environments with a comprehensive security approach. The foundation of our differentiation are the thousands of New Era employees, industry experts, around the globe delivering against our portfolio of global lifecycle services capabilities in: Field Services Professional Services Managed Services Program Office / Program Services This integrated services model allows us to deliver consistent, scalable outcomes from planning and deployment through ongoing optimization and support-anywhere in the world. We deliver innovative solutions to achieve mission critical business outcomes by bringing to bear an eco-system of strategic industry partnerships with the likes of Microsoft, Cisco, and Genesys just to name a few. The Sales Director, Mid-market will be responsible for the performance and development of all sales related activities. The Sales Director manages a diverse team of portfolio sellers to provide constant leadership, mentoring and support - aligning sales team objectives with New Era's overall strategy, vision and goals. The Sales Director will evaluate and lead existing teams while developing, recruiting and hiring additional talented Account Executives to support continued growth. This role is accountable for team performance, pipeline health, territory coverage, and supporting a team culture across the assigned territory and the overall New Era sales organization. The Sales Director is a key member of the Mid-market Leadership team and will strive to meet both personal and team goals. The ideal candidate has experience leading services led portfolio sellers across verticals, geographies, leveraging multiple OEM relationships to deliver outcome-based solutions to clients. We are seeking a highly motivated, data-driven sales leader who excels at coaching, team development, and GTM execution. Someone who is a self-starter, possesses a strong work ethic, and is committed to the growth & success of New Era and its customers. HIERARCHY: The Sales Director, Mid-market reports directly to the Senior Sales Vice President, Mid-market, who reports to the Chief Revenue Officer. The Sales Director will also work closely with the Operational and Finance Leadership across New Era. PRIMARY DUTIES: Responsible for the overall management, mentoring, leadership, and strategic development of the sales team. Lead Account Executives across multiple locations - as a single sales team - promoting a high-performance, accountable sales culture. Implement sales and support strategies, techniques, and tactics based on customer feedback, senior management teams and market environment. Ensure Account Executives are trained to understand and identify opportunities & be able to present all New Era solution offerings. Responsible for the development of the sales team to include CRM adoption, process improvements, employee skill enhancement, and motivation techniques. Regularly monitor & communicate sales performance metrics to identify specific areas of improvement for the sales team or individual Account Executive(s). Coordinate weekly, monthly, and quarterly team sales meetings to review forecasts, discuss strategy and provide training for Sales team, to include product and industry updates, sales strategies, selling skills, etc. Collaborate with internal business leaders and marketing team to develop sales and marketing collateral for new services and offerings. Collaborate with and support New Era's Alliances team to leverage manufacturer and distributor relationships to drive sales, while partnering and building relationships to do joint account planning and demand creation. Collaborates with other local senior managers, regional management and national management to continuously improvement processes and initiatives. Actively participates in management team functions including offering ideas, insights and recommendations on the presentation of New Era service offerings, new business and other topics that ultimately impact the overall quality of the Company. Conduct performance reviews, provide frequent feedback, individualized mentoring and address performance issues when necessary. Ownership and accountability for sales planning, forecasting, and reporting to ensure alignment with regional and national goals. Work well with and demonstrate respect for colleagues at all levels and consistently contribute to a positive work environment for the entire staff. Identify wallet-share expansion and new business opportunities, participate in new business pitches and assist in drafting new business proposals. Maintain relationships with key accounts for direct and/or indirect support and escalation. Assists in strategic sales efforts as needed. Leverage existing networks including customers, manufacturers, distributors, consultants, etc. to drive pipeline and sales growth. Champion a team culture, fostering collaboration, trust, and a customer-centric mindset across the New Era sales organization. Ensure compliance with all GTM processes, reporting, and cadences. COMPETENCY: Superior written and verbal communications skills. Proficient with Hubspot CRM, Co-Pilot, Microsoft Excel, Word, Power Point, and other productivity tools. Strong, proven supervisory and employee/team development skills. Demonstrated ability to lead others in the achievement of business and/or sales targets. Ability to motivate others and inspire high performance, loyalty, and customer satisfaction. Strong team work ethic and ability to motivate others to inspire accountable, high performing, collaborative teams. Strong OEM relationships with New Era Strategic Partners. Ability to successfully work under pressure, multi-task, prioritize and effectively manage one's time. Commitment to maintain pace with evolving technologies and products. Ability to interact at all levels of the organization. Demonstrated ability to develop and successfully implement strategies. Ability to pass a comprehensive background screening process. EXPERIENCE: At least five years of Technology Industry Sales Management experience, with proven success of meeting / exceeding goals. Demonstrated success in services-led sales, including Field Services, Professional Services, Managed Services, and Program Services, with the ability to position and sell complex service offerings to executive-level buyers. xperience managing multi-vertical market, multi-technology, multi-manufacturer. environments sales team. Strong management, coaching, and mentoring skills. Forecasting sales and pipeline management. CRM Management. Experience leading teams remotely across large geographic areas. Experience working with Mid-market accounts is desirable. Experience working within state and local government space is desirable. QUALIFICATIONS: To perform the job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. REQUIRED EDUCATION: Bachelor's Degree or equivalent experience LANGUAGE SKILLS: English PHYSICAL DEMANDS: Regularly spend long hours sitting and using office equipment and computers. Regularly use hands and fingers to operate a computer keyboard, mouse and other office equipment. Regular, repetitive movements such as typing, mouse movements and scrolling. Ability to hear and understand spoken communications, both in person and via remote communication tools (e.g., phone, video conferencing). Ability to see and read computer screens and printed documents, as well as adjust focus. This includes prolonged periods of looking at a computer screen. Regularly see details of objects that are less than a few feet away. Regularly speak clearly so listeners can understand. Regularly understand the speech of another person. Frequently work on projects that require deadlines. WORK ENVIRONMNET: Hybrid work model including New Era offices and client sites within the designated geographic region. EXPECTED HOURS OF WORK: Business hours are Monday through Friday 8:00 AM to 5:00 PM. However, required work hours may vary depending on business needs. TRAVEL: Estimated 50%+ US Based travel required QUALIFICATIONS: To perform the job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice. EEO/AA Statement New Era Technology provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, national origin, religion, pregnancy, marital status, gender identity, age, physical or mental disability, or covered veteran status. In addition to federal law requirements, New Era Technology complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. New Era Technology, Inc., and its subsidiaries (“New Era” “we”, “us”, or “our”) in its operating regions worldwide are committed to respecting your privacy and recognize the need for appropriate protection and management of any Personal Data that you may provide us. In this, we are also committed to providing you with a positive experience on our websites and while using our products, services and solutions (“Solutions”). View our Privacy Policy here ********************************************* We never ask candidates to pay any fees at any point in our hiring process. If you are ever asked to provide payment for training, certification, equipment, or any other purpose, it is not from our company. Only communications from our official company channels should be trusted. Please note our official email domain is @neweratech.com. If you suspect fraudulent activity, please contact us immediately at privacy@neweratech.com .
    $95k-172k yearly est. Auto-Apply 1d ago
  • Repository Specialist I (Sample Management Associate)

    Charles River Laboratories 4.3company rating

    Maryland job

    For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. Job Summary We are seeking a Repository Specialist for our Insourcing Solutions team based at our facility in Frederick, MD. As the Repository Specialist, you will receive, handle and inventory specimens of human, animal and/or plant origin at temperatures ranging from ambient to -195°C, as well as weigh and prepare samples for pickup, courier delivery and shipment. Additionally, you will be tasked with maintaining repository files for validation of data and preparation of reports, as well as review accumulated data for accuracy and prepare reports of information and sample data. Additional responsibilities include: Assemble and display data for the storage and retrieval of specimens and for report preparation. Perform freezer inventories, as well as operate and freeze specimens utilizing controlled-rate freeze equipment. Participate in temperature/liquid nitrogen (LN2) liquid level monitoring and emergency response rotations. Process and aliquot specimens. Enter data into client's online repository database for sample tracking and inventory management. Driving client vehicle to deliver and pick-up specimens locally. Job Qualifications The following are minimum requirements related to the Repository Specialist position: High School Diploma or equivalent Valid driver's license A minimum of two years related office and administrative experience preferred Experience working in a shipping/receiving environment with scientific data preferred An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. The pay for this position is $20.00 per hour. About Insourcing Solutions Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit ***************
    $20 hourly Easy Apply 38d ago

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