Catalent Pharma Solutions Remote jobs

The Account Executive, Wellness will be responsible for growing Catalent's Consumer Healthcare business in their assigned region within the United States and Canada. Primary focus will be to develop and execute an account plan for strategic management of existing account base, as assigned, and continued growth in the nutritional dietary supplement industry, providing our customers with solutions and ultimately growing Catalent's portfolio of business. The Account Executive, Wellness role is ideally filled by a high energy, team player who is not afraid to roll up his or her sleeves, who thrives in a fast moving, lean, and entrepreneurial environment. This is a field-based, remote role with travel required for business development related activities. The Role: * Account Management: * Customer Relationships: Manage business relationships with assigned customers, including pricing, contract extensions/amendments, forecasting, periodic business review meetings, and addressing customer service-related issues. * Account Planning: Set account objectives and establish plans to achieve results. Ensure alignment with Catalent's Standards of Business Conduct. * Engage daily in activities that drive meeting or exceeding financial targets. * Internal Coordination: * Cross-Functional Collaboration: Work with internal teams across Catalent (Customer Service, Commercial Operations, Marketing, Legal, Finance, Project Management) to maintain effective communication with key internal stakeholders to ensure all account management activities are conducted in a coordinated, team-based fashion. Collaborate with other selling teams within Catalent to actively engage in cross-selling opportunities. * Internal Meetings: Plan and participate in regular internal business review meetings to present strategic plans and progress within the assigned territory. * Opportunity Management: * Sales Funnel Development: Develop and build the funnel to drive new business through prospecting, outreach, relationship building, and qualifying leads, captured in Salesforce with specific actions leading to successful closures. * Sales Process Management: Manage opportunities from start to finish, including tracking in Salesforce, defining scope, creating pricing strategies, handling customer credit, confirming confidentiality agreements, negotiating, and closing deals. Ensure thorough and timely handoff to internal project managers and product development teams. * Customer Interaction: * Consultative Approach: Employ a consultative approach with regular meetings for capabilities reviews, site visits, business updates, and innovation discussions. Prepare well for calls/visits with a clear agenda and meeting outcome goals. Must be natural and curious in front of customers to understand client needs and develop tailored, innovative solutions. * Communication and Presentations: Develop and deliver customer-facing presentations, leveraging existing resources to create a unique value proposition. Use formal and informal communication methods to assure a detail-oriented approach to follow up with rapid response and follow through to customer inquiries, opportunities, and issues. * Market and Competitive Analysis: * Market Intelligence: Gather and analyze competitive intelligence through trade shows, articles, newsletters, and customer feedback. Stay informed about market trends and new launches in collaboration with Catalent's Marketing Team. * Competitive Positioning: Use gathered intelligence to inform and enhance Catalent's competitive positioning in the industry. * Administrative Responsibilities: * Compliance and Reporting: Adhere to corporate responsibilities by staying current with internal training, tracking opportunities, submitting expense reports, managing time off, and complying with travel and gift policies. Ensure confidentiality and ethics standards are met. * Goal Setting and Career Development: Engage in annual goal setting, track progress, and drive career development activities with your director. Pursue continuous learning through feedback, mentorship, and professional development opportunities. * Travel: * Travel Requirements: Travel 25-50% to Catalent sites, customer sites, tradeshows, and industry events. A passport is required. * Additional Duties: * Other tasks and duties as assigned. The Candidate: * A BS/BA degree is required. * Minimum 3 years in a business development role, with relevant experience in the outsourcing market (CMO, CRO, CSO) preferably in the nutritional dietary supplement space. * Excellent oral and written communication and presentation skills required. * Proven ability to organize and plan work, manage travel, and balance multiple priorities effectively required. * Ability to work effectively as a member of cross-functional teams required. * Strong computer skills required, including Microsoft Word, Excel, and PowerPoint. * Experience using Salesforce or similar customer relationship management tools preferred. * Must be willing and able to travel up to 50% to visit clients, attend tradeshows, participate in training, as well as meet with clients in Catalent's manufacturing facilities. * This position required to work from home is not eligible for relocation assistance. Why You Should Join Catalent: * Join a high growth and fast paced organization with a people focused culture * Global exposure, defined career path and annual performance review and feedback process * Competitive Medical, Dental, Vision, Life Insurance, and 401K * 19 days PTO & 8 paid holidays Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

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. At Parexel, we don't just support drug development-we help shape it. As a Senior/Vice President, Technical on our Regulatory Strategy (RS) team, you'll be at the forefront of innovation, guiding biopharma companies through complex regulatory landscapes to bring safer, more effective therapies to patients worldwide. You will: • Lead strategic regulatory initiatives across diverse product types and global markets • Advise clients throughout the product lifecycle, from early development to post-marketing • Share your scientific, technical, and commercial expertise to influence regulatory outcomes • Collaborate with and lead teams of respected subject matter experts • Represent Parexel as a visible thought leader in the industry • Meet new situations and learn all the time. In fact, one of the key characteristics you'll see in our Sr/VP Techs is innate curiosity along with a passion for the science, the industry, and public health. If you're committed to public health and want to make a difference, this is the ideal role. We're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team! A Senior/Vice President Technical must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations. A Senior/Vice President Technical must have a thorough understanding of the organization's consulting models and methodologies, as well as extensive knowledge of what services RS provides. A Senior/Vice President Technical provides a full range of consulting services and works within their personal area of expertise. A Senior/Vice President Technical provides mentoring and guidance to other RS employees and leads knowledge-centered activities within RS. A Senior/Vice President Technical participates in the development of new service offerings, consulting models and methodologies. Project Execution Works within a team environment or individually based on project needs Works within broad project guidelines and leads issue and conflict resolution Prioritizes own workload and prioritizes the workload of the project team to achieve the project scope and objectives Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions Produces quality work that meets the expectations of RS and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and RS are met Manages project engagements (small or large) Interacts with the assigned Project Assistant to ensure accurate financial management and for general project support Provides guidance to project team members and acts as a mentor to junior staff Thought Leadership Frequently presents speeches or seminars to industry groups based on recognized expertise in his/her field Frequently authors articles for publication in industry magazines, newsletters, book chapters and other forums Reviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of RS are met Regularly quoted by general and industry news outlets When applicable, serves as a leading member of industry association boards, task forces and committees and/ or as chairperson or officer of one or more professional associations Contributes expertise to professional societies, academic or other similar groups influential in his/her area of expertise Reinforces the knowledge-centered activities within RS based on their own knowledge and expertise Facilitates improvements to Parexel business processes Facilitates new service and consulting model development Consulting Activities and Relationship Management Adapts the appropriate organization's consulting models and methodologies when unique situations present themselves as well as designs/improves the methodologies when needed Provides a full range of technical and/or business consulting services across multiple disciplines of services including representing clients to regulatory agencies Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction Acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined Acts as a loaned executive for a client when required Facilitates resolutions to possible problems or conflicts within the project team and/or the client Provides guidance as needed to lower-level colleagues on appropriate methods of executing project activities Develops and implements business solutions addressing specific client needs using expertise, best practices and knowledge of the client's business and key industry drivers Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization. Presents to client boards and provide strategic advice to the C suite Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and build relationships which results in additional business or referrals Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with RS management and account management Requirements Education - MD required Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and expertise in reviewing and evaluating clinical sections of regulatory applications. Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master Medical Review Officer, Team Lead, etc. or a related medical role is required. Depth of experience will be considered when determining the level of Senior Vice President Technical or Vice President Technical Extensive Endocrinology, Neuroscience, Rare Disease, or Immunology experience is required. The ability to travel up to 20-30% domestically and/or internationally may be required for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance #LI-LB1 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.

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. Join Our Medical Communications Team at Parexel as a Senior Program Specialist Are you a seasoned project manager or account manager with experience in medical communications-particularly in publications? We're seeking a Senior Program Specialist to lead the execution of complex, multidisciplinary publication programs while driving excellence across cross-functional teams. This is a full-time, remote position that may require occasional travel. This is a full time remote position. Candidates need to work out of Canada or the continental United States. What You'll Do As a Senior Program Specialist, functioning as a program/project manager you will: Lead and facilitate program/project kick-off meetings, establishing clear roles, responsibilities, and expectations across internal teams and external stakeholders. Develop and manage comprehensive project plans, delivery schedules, and tracking systems to ensure timely, high-quality execution. Maintain proactive communication with clients, faculty, and internal teams, serving as the key point of contact for project status updates and issue resolution. Monitor budgets, timelines, and deliverables, identifying risks and resolving issues promptly to keep projects on track and within scope. Collaborate cross-functionally to define project scope, staffing requirements, and implementation strategies, raising concerns and adjusting plans as needed. Support proposal development and budgeting processes, contributing to program specifications, cost assessments, and implementation planning. Champion best practices in communication, process efficiency, and team collaboration, continuously identifying opportunities for improvement and innovation. Ensure alignment with strategic goals and product messaging, working closely with Account Managers/Directors and functional teams to deliver impactful solutions. What You Bring Must have 5+ years experience in medical communications project management, (Publications). Proven ability to lead teams and deliver projects on time and within budget. Strong organizational, negotiation, and interpersonal communication skills. Advanced proficiency in Microsoft Word, PowerPoint, Excel, Outlook, and database tools. iEnvision experience is required. Familiarity with publication guidelines (e.g. ICMJE). Bachelor's degree required; Master's preferred in Business or Life Sciences. Why You'll Love Working Here Be part of a collaborative and innovative team. Work on impactful healthcare and scientific programs. Enjoy a flexible work environment with growth opportunities. Ready to make a difference? Apply today and bring your expertise to a team that values excellence, innovation, and collaboration. 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.

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. Parexel is hiring a Principal Biostatistician to work remotely. The Principal Biostatistician works independently on all level complexity clinical trial projects, often with major regulatory impact. The person will be recognized internally and externally as a statistical expert. Location: United States - Remote Key Accountabilities: Operational Execution Provide broad statistical support, including trial design, protocol and CRF development on specific studies Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review Business Development Support of Business Development, by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings General Activities Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis Understand, apply and provide training in extremely advanced and sometimes novel statistical methods Contribute to the development and delivery of internal and external statistical training seminars and courses Review position papers based on current good statistical practice Interact with clients and regulatory authorities Review publications and clinical study reports Travel to, attend, and actively contribute to all kind of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results) Additional responsibilities as defined by supervisor/manager. Skills: Good analytical skills Good project management skills Professional attitude Attention to detail Thorough understanding of statistical issues in clinical trials Ability to clearly describe advanced statistical techniques and interpret results Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines) Prior experience with SAS programming required Ability to work independently Good mentoring/leadership skills Good business awareness/ business development Knowledge and Experience: PhD or MS in Statistics or related discipline with substantial experience The knowledge of pharmacokinetic data is an advantage Competent in written and oral English in addition to local language Education: PhD in Statistics or related discipline, MS in Statistics or related discipline 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.

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. Parexel FSP has an exciting opportunity for a Senior Precision Medicine Associate. This role works closely with line Manager, Precision Medicine, and other key personnel to implement and operationalize Precision Medicine goals within client clinical trials. Manages central laboratory and specialty vendors on low to moderately complex clinical trials. Performs other duties as necessary to ensure optimal clinical trial execution. Key Accountabilities: Study Team Support Collaborates within cross functional study teams Presents at investigator meetings and creates training materials (lab manual, sample collection procedures and presentation slides) Manages acquisition of clinical trial samples Provides support for sample related matters to clinical study teams Works with Informed Consent Form (ICF) Specialist and Precision Medicine Operations Lead (PMOL) to ensure compliance with ICF permissions Operational Support of Biomarker and Exploratory Analysis Assists PMOL with vendor selection and oversight Executes biomarker plans in collaboration with the study team and PMOL Provides input to clinical trial related documents under the supervision of the PMOL Selection of Central Laboratory and Specialty Vendors Prepares Request for Proposal (RFP), reviews and assesses bids and statements of work Manages biomarker vendors for low to moderately complex clinical trials Coordinates capabilities presentations by third party vendors Central Laboratory and Specialty Vendors Management Communicates with academic collaborators Participates in oversight activities with vendors and supports audits as required Data Acquisition and Management Supports information exchange and maintains data integrity Provides guidance and training to clinical sites, collaborators and vendors under supervision of the PMOL Supports sample and data reconciliation activities Compliance with Parexel standards Complies with timely completion of required training curriculum Completes timesheets accurately as required Submits expense reports as required Updates CV as required Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: Effective problem-solving skills with internal and external stakeholders Comfortable presenting to internal and external audiences Proficient in written and spoken English required Proficient in local language, as applicable, preferred Project management and organizational skills Ability to effectively multi-task and prioritize Ability to work in a global matrix environment Proficiency in widely used technologies and ability to learn client applications (especially Microsoft Excel) Problem solving abilities, troubleshooting, resourcefulness, and attention to detail Knowledge and Experience: Minimum of 6 years relevant industry experience is required Science background and working knowledge of a wide array of medical terms, biological assays including proteomics, cellular assays and genomics Understanding of bioethics of human biospecimen collection and research May require oncology experience Education: Bachelor of Science degree or equivalent Biology or equivalent major preferred 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.

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. Parexel FSP is looking for a Principal Medical Writer! This is a remote role anywhere in the United States or Canada. Job Purpose: The Medical Writer, Medical Writing, is responsible for writing and overseeing the completion of a broad range of documents in support of company products and projects. This individual will work with the lead and/or program medical writer and independently to develop messages and write, substantively rewrite, and edit documents for clarity and accuracy, ensuring high quality. This individual will help manage project documents and timelines, as well as ensuring that documents comply with International Committee on Harmonization guidelines, Sponsor SOPs, Good Clinical Practices, and Good Publication Practices. As a study team member, this individual will work with domestic and international colleagues across R&D (as appropriate).to ensure that documents meet the company's objectives. Key Accountabilities: Oversight of activities • Write and edit clinical regulatory documents for clarity, and accuracy according to Sponsor standards. • Work with lead writer and project team to develop document messages and data presentations within submission timelines to meet company objectives. • Provide writing support for a wide range of documents, including but not limited to investigator's brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs. • Ensure that documents comply with International Conference on Harmonization guidelines, Sponsor Pharmaceuticals SOPs, and Good Clinical Practices. Collaborative relationships • Collaborates effectively with lead writers and project teams to develop and refine clinical regulatory documents that align with Sponsor standards, ICH guidelines, and Good Clinical Practices, ensuring clear and accurate communication of study data and objectives within submission timelines. Compliance with Parexel standards • Complies with required training curriculum • Completes timesheets accurately as required • Submits expense reports as required • Updates CV as required • Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: • At least 4 years of writing experience in the pharmaceutical industry • Experience with a variety of regulatory and clinical documents • Experience in a matrix team environment • Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents Knowledge and Experience: • Ability to write and edit complex material to ensure accuracy and clarity, • Excellent written and oral communication skills and demonstrated problem-solving abilities • Ability to handle multiple projects and short timelines • Ability to work cooperatively with colleagues in a wide range of disciplines Education: • BA/BS or higher 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.

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 an experienced individual for our Corporate Counsel - Labor & Employment position within our Legal Department. Working with other members of the legal labor and employment team, provide analysis and counsel to management and HR on global labor and employment issues including recruitment and hiring, discipline, reorganizations, training, company policies, employee handbooks, compensation and benefits issues, etc. Draft, negotiate and review documents relating to executive employment, as well as general HR-related contracts including separation agreements. Develop and recommend company policy and position on worldwide labor and employment issues to ensure company compliance with local, state and federal regulations related to employment (Affirmative Action, ADA, FLSA, FMLA, EEOC, MCAD, NLRB, USERRA etc.) and related regulations in other jurisdictions where employees are situated. Handle employment -related litigation, mediations, hearings (EEOC, etc.), and arbitrations. Anticipate and guard against labor and employment legal risks facing the company. Provide general legal support, when appropriate. **Position is remote and will require occasional domestic and international travel. Essential Duties and Responsibilities + Provide analysis and counsel on labor and employment issues globally. Key areas include recruitment and hiring, discipline, reorganizations, training, company policies, employee handbooks, compensation and benefits issues. + Assist with legal compliance initiatives (policies, trainings, processes, etc.) related to employment and labor areas for the global workforce, as well as in other areas requested from time-to-time, and otherwise provide support generally to members of the legal compliance function. + Draft, negotiate and review documents related to senior executive employment and compensation, including benefits plan documents (including ERISA, COBRA and 409A issues), change-in-control agreements, and employment offer letters. + Draft, negotiate and review both routine and complex HR-related contracts including separation agreements. + Prepare and conduct training for HR and business partners on labor and employment issues and best practices. + Provide counsel on employment disputes, including EEOC, NLRB, MCAD and other discrimination complaints. + Recommend, advise and enforce company policy and position on worldwide labor and employment issues to ensure company compliance with local, state and federal regulations related to employment (Affirmative Action, ADA, FLSA, FMLA, EEOC, MCAD, USERRA etc.) and related regulations in other jurisdictions where employees are situated. + Manage outside counsel on employment litigation matters. + Review employment, labor and benefit issues as part of our acquisitions and divestiture teams, and provide related advice, counsel and risk assessments during the evaluation process. + As requested, serve as Legal Department representative on acquisition integration processes. + As requested, serve as Legal Department representative on Policy Management Committee. + Provide legal counsel on issues arising from actual or anticipated employment-related lawsuits. + Assist in the development and recommendation of company policy and position on employment-related legal issues. + Monitor and analyze changes to employment-related laws and regulations to ensure continued company compliance. Proactively advise management on changes which may affect the business and recommend actionable guidance. + Establish a strong partnership with HR and business teams, providing practical and sound labor and employment advice. + Provide backup legal support for general corporate legal issues as required. + Perform all other related duties as assigned. (Note: Position may be requested in the future to also serve as principal counsel to one or more businesses or functions, including coordinating the delivery of legal services to the businesses/functions and collaborating and establishing strong relationships with their respective leadership teams.) **Job Qualifications** + Education: Bachelor's degree (B.A./B.S.) and Juris Doctor or equivalent from an accredited law school. + Experience: Five or more years of related experience, preferably in a combination of a law firm and corporate setting. + An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. + Certification/Licensure: Current license in any US State Bar as an attorney qualified to practice law. + Other: Knowledge of labor/employment-related statutes and regulations. Strong interpersonal and communication skills. Compensation Data The pay range for this position is $180K - $210K USD annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. **About Corporate Functions** The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement. **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 *************** 231226

* Candidates must reside in the Dallas, TX area* Purpose and Scope Under limited supervision, the Account Manager- PE is responsible for achieving sales objectives in assigned territory through the development, maintenance, and enhancement of the business. These customers include Pediatric Endocrinologists, nurses, pharmacists, pharmacy and therapeutics groups, teaching institutions, private and federal hospitals and formulary committees. The Account Manager- PE is responsible for ensuring customer's clinical conviction in the product and seeing the sale through to its conclusion by providing sufficient training and ongoing customer service. The Account Manager- PE will develop territory business plans and work with the sales management team to maximize the impact of sales and marketing plans and tactics. Essential Duties & Responsibilities Create, maintain and increase sales within designated territory by influencing the prescribing habits of the targeted audience by calling on health care providers and health-related organizations within assigned territory. Strategically identify and develop relationships with non-prescribing health care providers that influence decision making in accounts such C suite personnel, pharmacy personnel, injecting nurses, Medical Assistants, office managers and personnel, etc. Sell in various sites of care within territory including clinics and health systems (all sites of care within health systems including but not limited to Specialty Pharmacies, In patient pharmacies, infusion centers, specialty clinics etc. Conduct effective and compliant mixing and administration demonstrations to appropriate customers Demonstrate advanced business acumen Demonstrate thorough on-label knowledge of products by effectively communicating appropriate clinical, technical, therapeutic, disease state and product information to customers. Complete routine reports and be compliant with industry, regulatory and company guidelines and prepare annual business plans and conduct quarterly analysis of the territory performance vs. plan. Attend and represent the Company at internal company meetings and external trade shows, community events, etc, as appropriate. Manage usage and inventory of promotional items to be given away to offices. Abide by Administrative Expectations as defined by AMP SOPs: Submit expense reports regularly as outlined, enter sales calls in CRM system daily or as indicated by Regional Sales Director, enter company car mileage weekly, maintain company car as required by Fleet Maintenance. Manage promotional budget effectively and in a compliant manner. Partner with different departments in the Company as the business requires. Abide by the Company's email and communication SOPs. Regular and punctual attendance is an essential function of the job. It is expected that our sales force is “in the field” calling on customers from 8:00am to 5:00pm each day. Responsible for reporting Adverse Events and Technical Complaints to Tolmar Pharmacovigilance and Patient Safety (PSSP) that you learn of per SOP-00821, Pharmacovigilance and Technical Complaint Reporting. Perform other duties as assigned. Core Values This position is expected to operate within the framework of Tolmar's Core Values: Center on People:We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.​ Are Proactive & Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.​ Act Ethically:We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace. ​Constantly Improve:We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.​ Are Accountable:We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.​ Knowledge, Skills & Abilities Highly motivated for success with a “can do” attitude. Excellent interpersonal, written and verbal communication skills and organizational skills Skill in negotiation and selling techniques as aligned with company expectations with demonstrated accountability in executing sales plans. Aptitude for learning technical and scientific product relation information. Demonstrate assertive selling techniques including asking for business on every call. Excellent analytical skills and proven strategic thinker. Ability to work independently and manage multiple projects both inside and outside the organization. Ability to execute effective business plans for assigned territory. Ability to develop working relationships with both internal and external customers and work as a team player with employees at all levels. Ability to take initiative in the absence of precise direction. Ability to demonstrate good judgment, discretion and compliance to industry ethical guidelines. Ability to be approved and insured to drive company fleet vehicle, including valid driver's license and good driving history. Knowledge of Microsoft Office products, CRM systems and virtual platforms. Education & Experience Bachelor's degree in science, business or related field. Consistent and proven track record of exceeding sales quotas. 5 or more years of successful independent pharmaceutical and/or business-to-business sales experience, Pediatric Endocrinology, Rare Disease and/or Buy and Bill sales experience preferred. Reside within the territory and willingness to cover the entire assigned geographical sales space. Pharmacy sales experience is preferred, including Specialty Pharmacy, Health System Based Pharmacies etc. Clinical experience helpful. Working Conditions Role requires sitting, driving and standing. Overnight travel is required for up to 75% of work week, dependent upon geographic footprint coverage expectations Ability to lift 50 pounds. Travel by air as required. Availability to work extra hours and on weekends as necessary. Compensation Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience. The pay range for this position at commencement of employment is expected to be between ($135,000-$155,000/year); however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. About Tolmar Tolmar is proud to have earned a reputation for performance and innovation. Through a progressive company culture, Tolmar has established a legacy as a trusted name in the research, development and manufacturing of high quality topical products used in dermatology, and extended release dosing forms for products commonly used in urology and oncology. Founded in 2006, we are a private company known internationally for our advanced drug delivery capabilities and our unmatched commitment to our partners, and to the patients and provider communities we serve. Since our inception, Tolmar has produced 22 marketed products supported by 5 New Drug Applications (NDAs) and 17 Abbreviated New Drug Applications (ANDAs) across urology and oncology and dermatology. With more products forthcoming, our dedicated pipeline reflects Tolmar's future-focused approach. Tolmar offers exciting opportunities that will leverage your abilities, expand your skills, and reward your contributions in an atmosphere that encourages both personal and professional growth. Additionally, Tolmar offers competitive compensation and excellent benefits including: Competitive and inclusive medical, dental and vision coverage options Flexible Spending Accounts for medical expenses and dependent care expenses HSA through our HDHP CompleteCare reimburses you and your dependents for eligible health care expenses and premium expenses incurred under alternate group health coverage Generous 401K match - currently match 100% of your contributions up to the first 6% of compensation and 50% from 7%-12%, but never greater than 9% Tolmar-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options Employee Assistance Plan, Legal Guidance and Funeral Planning & Concierge Services Adoption and family-planning benefits, Fertility and Family Forming Benefits Generous paid time off, including: Vacation, sick time and holidays Volunteer time to participate within your community Discretionary year-end shutdown We provide a positive work environment designed around the philosophy of mutual respect and the challenge and rewards of contributing to the continued success of our organization. Tolmar is committed to fostering, cultivating and preserving a culture of diversity, equity and inclusion. Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

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** The Principal System Administrator-HR Shared Serices is a member of the Global HR Operations team, and is responsible for the effective configuration, management, maintenance, and optimization of our Neocase HR system. This role ensures that the system supports efficient HR service delivery, meets business requirements, and provides a seamless user experience for employees and HR teams. The analyst role will collaborate with HR, IT, and business stakeholders to implement enhancements, resolve issues, and drive continuous improvement in system performance and functionality. This is a remote opportunity, with preference to be based within the U.S. Key Responsibilities System Administration & Configuration + Manage day-to-day administration of the Neocase HR case management system, including user access, permissions, and security settings. + Configure workflows, forms, templates, and case categories to support evolving HR processes and business needs. + Maintain and update knowledge base content within Neocase to ensure accuracy and relevance. System Support & Issue Resolution + Serve as the primary point of contact for Neocase system issues, troubleshooting and resolving incidents promptly. + Liaise with IT, HR, and Neocase support teams to escalate and resolve complex technical issues. + Monitor system performance and proactively address potential disruptions or inefficiencies. Enhancements & Continuous Improvement + Gather and analyze user feedback to identify opportunities for system enhancements and process optimization. + Test, implement, and document new features, upgrades, and integrations in partnership with IT and HR stakeholders. + Ensure system documentation, user guides, and training materials are up to date and accessible. Reporting & Analytics + Develop and maintain dashboards and reports to track case volumes, resolution times, and other key metrics. + Provide regular reporting to HR leadership and stakeholders to support data-driven decision-making. Compliance & Data Security + Ensure the Neocase system complies with organizational policies, data privacy regulations, and security standards. + Support audits and data integrity checks as required. **Knowledge / Skills / Capabilities** Knowledge: + In-depth understanding of Neocase and other case management tools. + Familiarity with HR processes and case management best practices. + Knowledge of system administration, workflow configuration, and user management. + Awareness of data privacy, security, and compliance requirements relevant to HR systems. Skills: + Strong technical aptitude with experience in system administration and troubleshooting. + Proficiency in configuring workflows, forms, and reports within case management platforms. + Analytical skills for interpreting data and generating actionable insights. + Effective communication skills for collaborating with technical and non-technical stakeholders. Abilities: + Ability to manage multiple priorities and respond quickly to system issues. + Ability to drive continuous improvement and optimize system performance. + High attention to detail and commitment to data integrity. + Strong problem-solving and critical thinking abilities. + Collaborative mindset for working across HR, IT, and business teams. **Job Qualifications** + Bachelor's degree in Information Systems, Human Resources, Business Administration, or related field preferred. + 5+ years of experience in HR systems administration and with HR case management software, experience with Neocase software strongly preferred + Familiarity with reporting tools and data analytics. + Experience with system upgrades, testing, and user support. + Ability to stay organized and track ongoing issues, both individually as well as within team project management + Excellent written and verbal communication skills + Ability to maintain confidentiality and discretion working with highly sensitive information **Compensation Data** The pay range for this position is $130,000 - $150,000K USD annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. **About Corporate Functions** The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement. **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 *************** 231156

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. US Homebased A Proposal & Contracts Specialist with Parexel is a client facing role and requires consistent management of the proposal and contract management processes, development of client-specific standards as required, documentation and negotiations. This position collaborates internally with varying levels within our organization requiring excellent customer service skills, attention to detail, and the ability to be persistent while communicating appropriately and effectively. Facilitates and guides the development of client-ready budgets for proposals and contracts deliverables. Key Accountabilities: Contract Development: Overall management responsibility for the contract process for specific or varied accounts including coordination of Operations, Project Management, Legal, Business Development and Finance to prepare, review, and negotiate contracts. Development of account specific standards for contracts, including presentation of budget, payment terms, standard contract language, etc., and discussion/negotiation with client as appropriate. Creates, negotiates, and finalizes contracts in accordance with departmental SOPs/guidance/work instructions. Amend project budgets as required in partnership with the project and functional teams ensuring all information is included from all groups. Utilize all internal tools and reports to appropriately amend client budgets. Develop a contract strategy to create the contract plan for delivery and client signature with accountable team members. Provide quality client deliverables to strict deadlines ensuring the formatted client grid presents the proper rationale for the cost changes. Attend all relevant internal meetings. Proactively leads and facilitates client meetings as required to negotiate costs and terms by targeted client signature date. Prepare draft contract documents from Parexel templates per guidance and in conjunction with relevant departments. Identifies and manages contractual issues that require finance/tax/other internal stakeholder input and applies lessons learned to similar scenarios in new contracts. Ensure all documents and files are saved in the appropriate areas and keep all data updated regularly in systems used for metrics and KPI purposes. Additional Tasks: Organize and manage time (e.g. Prepare sufficiently detailed handoff before taking time off, develop contract plans and structure work priorities / deliverables). Proactive management of process and deadlines. Serves as a resource for less experienced team members (e.g. mentor, SME). Aids team members as workload allows. Analyzes, and makes recommendations when asking questions/seeking guidance/approval. Adhere to internal / external expectations and deadlines. Map client bid-grids independently; review and update mapping references to pricing tool as required. Participates in projects/initiatives as needed (i.e. process improvement initiatives, tool refresh, change champion, etc.). Skills: Strong understanding of the different operational aspects of clinical study conducts in different regions across the world, which may be demonstrated by previous work experience in the industry. Has standard knowledge of managing client contract processes and accounts, reporting. Strong analytical and organizational skills with ability to perform several tasks simultaneously. Consistently performs high quality work and delivers on time under pressure. Impressive problem-solving skills and ability to make effective, appropriate decisions when necessary. Effective escalation management understanding when to bring in support and/or escalate difficult situations and interactions. Excellent attention to detail, excellent oral/written communication skills along with highly developed interpersonal and strong team orientated skills. Ability to proactively lead internal meetings and with clients. Ability to negotiate client discussions with minimal support. Ability to work independently and without close supervision in order to meet deadlines. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail. Approaches work with a sense of urgency and a positive attitude. Knowledge and Experience: Broad experience in proposals and contract management., the principles, contractual terms, pricing structures, pricing tools and data systems (e.g. Salesforce). Comprehensive knowledge of relevant software (Windows, Word, Excel, Outlook, Databases). Comprehensive knowledge of cash flow and revenue recognition. 4-6 years of previous experience in project support, finance, contracting, or proposals in a CRO or similar environment. Previous experience in proposal development is a plus. Multinational and multicultural companies experience is also a plus. Ability to work from home. Ability to work irregular and/or extended hours as needed to meet the client's proposal deadline. Supervisory experience is a plus. Education: Bachelor's Degree in Life Science, Business, Languages or equivalent combination of education and experience. MBA preferred. 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.

**Bring your Rheumatology experience and Lupus expertise to an Industry Leader, Parexel!** Building on our continued success, we are expanding our esteemed Medical Sciences Team and seeking an Associate/Medical Director to support the growth of our Global Immunology and Inflammation Therapeutic Franchise. As an Associate / Medical Director, you will work closely with some of the best and brightest in the industry and assist our clients in the journey of getting new and innovative drug treatments into the hands of those who need them most. You will be a member of a fantastic and cohesive global team with great mentors and work with small to large clients across a broad spectrum of diseases. Overall responsibilities of the Associate / Medical Director are to: - Provide medical and safety monitoring for assigned projects - Provide medical expertise and leadership to support business development and pre-award activities Supporting Activities - Medical Support / Medical Monitoring for projects and studies contracted to Parexel - Deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e.: tasks and time per task contracted) and according to the assigned role (Global Lead Physician GLP or Regional Lead Physician RLP). Medical support includes but is not limited to the following: + Participate actively in study planning with feasibility leaders, solution consultants + Participate in team project and investigator meetings + Provide training of study teams on TA indication and protocol Note that this does not include any direct medical advice on patient care or management + Communicate with relevant sponsor counterparts on challenges and accomplishments related to assigned project/study. + Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc. in conjunction with clients/sponsors or in conjunction with other Parexel departments + Deliver medical monitoring activities according to MMP during the study conduct + Answer to site/ study team questions relating to the study conduct or protocol + Review and sign off all data listings / tables, protocol deviations, datasets, for medical accuracy/consistency in accordance with study plans (Medical Monitoring Plan, Medical Data Review Plan, Data Surveillance Plan etc. + Deliver medical leadership to the project in close coordination with the Project Leader according to the role assigned either GLP or RLP by: + Timely identifying risks and challenges + Pro-actively proposing and/or delivering relevant actions contributing to the success of the study/project and risk mitigation + Creating a sense of urgency on any matters pertaining to safety of study participants and scientific integrity of the study + Attending and supporting any audits or inspections pertaining to assigned studies even if not directly involved in the audited activities + Participating in periodic rotas including night and weekend shifts e.g. for emergency medical contact and emergency unblinding phone requests for Parexel studies, as applicable and/or appropriate for the MD + Providing risk assessment of clinical trials for local sponsorship as needed with the support of the designated Senior Medical Director/ Global Head of TA (as appropriate) Pharmacovigilance Support - Provide medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse events. - Support regulatory safety reporting activities - Ensure client needs and concerns are addressed to ensure customer satisfaction - Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities in order to enhance client satisfaction - Follow up sponsor satisfaction metrics pertaining to medical activities in assigned studies and propose /execute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction Business Development Support - Support Business Development, as agreed with Line Manager, while adequately balancing time devoted to this activity with billable tasks - In line with business development objectives, meet and attend phone conferences with clients to communicate and detail Parexel medical expertise and experience in a therapeutic area or in an indication - Provide medical expertise/ leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings - Attend preparation meeting and Bid pursuit meetings as required - Provide support for marketing activities as requested. - Share sponsor insights and experiences (strategy, history, culture, priorities etc.) with peer and proposal teams Medical Expertise - Provide medical expertise to client as contracted across multiple channels and interactions such as: --Consultancy on protocol development, drug development program etc. --Medical review of various documents which might be audited by clients and regulatory agencies More generally in any client interactions: --Provide medical expertise and training to other Parexel personnel, as required. --As appropriate write clear, concise medical documents --Participate in activities to raise, coordinate and promote Parexel medical expertise both internally and externally including but not limited to internal therapeutic area meetings, trainings, white papers, slide sets, publications etc. Skills - Experience in clinical medicine (general or specialist qualifications) with a specialty Fellowship in a "therapeutic area" which is expected to be kept up-to-date - Experience leading, mentoring and managing individuals/ a team, preferred, but not essential - A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution, preferred - Good knowledge of the drug development process including drug safety, preferred - Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts - Excellent time management skills - Client-focused approach to work Successful applicants will be - Medically qualified in an acknowledged medical school with completion of applicable clinical training (residency, internship, fellowship) - Board certified/Board eligible in Rheumatology with extensive clinical experience -Expertise in Lupus is preferred -Experienced as a Physician in Industry or as a clinical trial investigator with significant clinical research experience The ability to travel 15-20% is required _**Internal candidates in the Americas who meet the Medical School requirements and who possess extensive experience treating rheumatology patients clinically and/or who possess extensive rheumatology clinical trial related experience will be considered for this home-based opportunity. **_ \#LI-LB1 \#LI-REMOTE 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.

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. Job Title: Data Management Lead (Medical Affairs) - Oncology Location: Fully Remote (US based) Must be able to accommodate West Coast hours. About Us: At Parexel, we are dedicated to advancing clinical research and supporting medical affairs with innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team. If you have a passion for clinical research, strong project management skills, and a knack for data management, we want to hear from you! Who You Are: Required: BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience. 7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data) Medical affairs experience (Phase IIIB - IV trials experience); Late Phase Oncology Strong project management experience Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required). Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity. Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and influencing. Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques. Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment. Ownership and accountability relative to key accountabilities in the job description. Ability to travel as required. Written and oral fluency in English. Preferred: Proficiency in programming languages such as SAS, R, Python, and SQL, with experience in advanced analytics approaches (e.g., machine learning, AI). Proficient with tools for analyzing large data sources with computationally intensive steps (e.g., SQL, parallelization, Hadoop, Spark) and producing interactive outputs (e.g., Shiny, Tableau). Experience with SDTM implementation, CDISC standards, standardized technologies (e.g., MedDRA, WHODrug), and reproducible research practices like version control and literate programming. BSN, RN, RPh, Pharm D, PA, MPH, or other applicable health professional credentials, with contributions to open-source packages, libraries, or functions. What you will be doing: Responsibilities will include: Develop risk management strategies and proactively manage timel What ines to ensure successful oversight and delivery of studies and projects. Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones. Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models. Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data. Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results. Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis. Cross-functional Data Management Leadership: Manage and coordinate the integration and utilization of all ancillary systems. Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive resolution with cross-functional stakeholders as part of the Risk Management Plan. Review and analyze metrics to derive meaningful summaries of study health and trends. Review Master Services Agreements, Service Level Agreements, and contracts to manage toward sponsor-specific metric targets/Key Performance Indicators. Attend cross-functional meetings, prepare meeting agendas and minutes, and comply with action and decision logs. Project Financial and Resource Management: Ensure appropriate project-level resourcing of staff and staff assignments. Regularly review and update Data Management resources to ensure alignment with contracted budgets, project resource forecasts, actuals, and demand. Determine and resolve the root cause of Data Management-related project variances in a timely manner, including negotiating/raising changes in scope. Company Initiatives: Provide Data Management functional input, considering the impact on Data Management and Parexel as a whole. Support other functions by providing meaningful feedback on initiatives. Ensure Parexel-requested information entered into management systems is accurate and regularly updated. Training: Maintain training compliance as per job roles assigned, including on-the-job training. Deliver project-specific training to internal Data Management teams. Address training needs based on identified development goals. 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.

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. Incredible, high-impact role with a Global Biopharma sponsor! Are you ready to turn your labeling expertise into strategic impact? We're seeking a sharp, detail-driven Senior/Consultant, Regulatory Labeling to join a dedicated partnership with a leading global biopharmaceutical company. In this high-visibility role, you'll be more than a consultant - you'll be a trusted collaborator whose insights help shape regulatory strategy and ensure patients worldwide receive safe, effective therapies with clarity and confidence In this role, you'll be the go-to expert for global labeling, working side-by-side with client teams across Regulatory Affairs, Technical Operations, Safety, and Commercial. You'll help navigate the complex regulatory landscape, ensure compliance across international markets, and drive continuous improvement in how labeling is developed, tracked, and delivered. Key Responsibilities: • Serve as the global labelling lead for multiple products, providing strategic direction and oversight. • Lead the development and maintenance of Company Core Data Sheets (CCDS), local labels, and associated labelling components. • Chair the Cross-Functional Labelling Team (XLT), facilitating the development of label updates and enabling senior management review and approval. • Ensure regional labelling compliance with CCDS standards. • Evaluate health authority comments for labelling implications and lead the development of appropriate responses. • Participate in Safety Management Team (SMT) and Global Regulatory Team (GRT) meetings to provide expert input on labelling matters. • Monitor emerging safety signals and assess potential impact on labelling. • Provide strategic insight and guidance on labelling topics to support regulatory and safety objectives. This role is ideal for a candidate with a strong background in regulatory affairs, labelling strategy, and cross-functional leadership. It offers the opportunity to make a meaningful impact on global product communication and patient safety. Additional Responsibilities: As a Senior Consultant/Consultant, Regulatory Labeling, you will partner with Label Strategist to: Conduct international labeling operations activities to support global new product and supplemental applications to product registration, and post approval launches for impacted international markets. Collaborate with Technical Operations team members to ensure commercial distribution, Regulatory Technology for labeling submissions, PV for safety reporting, and other functional groups. Provide labeling to Advertising and Promotion for marketing pieces, and with Commercial for website postings if needed. Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control. Utilize regulatory/product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines. You will also: Be responsible for executing and effective quality control reviews and tracking (primarily) internally used labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use) and outward facing local/regional labeling (USPI, Med Guide, SmPC, PIL, Canadian Product Monograph, Instructions for Use) as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents. Act as operational expert for Global Labeling tracking in RIMs, SPL generation, ensure development and maintenance of templates, collaboration features and system upgrades. Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading/editing skills and compiling supportive documentation. Support labeling inspection / audit readiness activities Education and Experience Bachelor's Degree plus at least 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. Exceptional candidates with 3+ years of labeling related experience may also be considered Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging) The ability to research and create comparator labeling documents Strong understanding and past experience creating annual reports The ability to collaborate with Tech Ops for artwork implementation Proficiency in SPL (all aspects, types and troubleshooting) and the ability to manage the review and approval of labeling in a document management system. Electronic document management systems use and / or electronic submission experience Knowledge and Skills Strong attention to detail Solid understanding and interpretation of US labeling regulatory requirements preferred Solid understanding of requirements for tracking of labeling updates Solid understanding of the pharmaceutical industry drug development process and willingness to learn global labeling regulatory requirements and industry practice Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS), Proficiency in MS Office suite; Willing to learn additional applications Understanding of label development and submission processes preferred. Ability to recognize and escalate issues Strong written and oral communication and organizational skills Ability to generate and initiate problem solving innovative solutions The ideal candidate should be action-oriented, customer focused, ability to manage workloads and set priorities. In addition, he/she should be capable of dealing with ambiguity, be creative, and be comfortable working with multifunctional teams If you thrive in fast-paced, high-stakes environments and love the idea of being a key player in a global regulatory role - apply today! #LI-LB1 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.

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 Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. Key Accountabilities: Site Management Responsibilities Contributes to the selection of potential investigators. In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. Actively participates in Local Study Team (LST) meetings. Contributes to National Investigators meetings, as applicable. Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. Updates CTMS and other systems with data from study sites as per required timelines. Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. Ensures data query resolution in a timely manner. Works with data management to ensure robust quality of the collected study data. Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. Follows up on outstanding actions with study sites to ensure resolution in a timely manner. Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. Assists site in maintaining inspection ready ISF. Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager Skills (Essential): Excellent attention to detail. Good written and verbal communication skills. Good collaboration and interpersonal skills. Good negotiation skills. Proficient in written and spoken English language required. Fluency in local language(s) required. Skills (Desirable): Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. Good analytical and problem-solving skills. Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. • Good knowledge of relevant local regulations. Good medical knowledge and ability to learn relevant Client Therapeutic Areas. Basic understanding of the drug development process. Good understanding of Clinical Study Management including monitoring, study drug handling and data management. Knowledge and Experience (Desirable): Familiar with risk-based monitoring approach including remote monitoring. Good cultural awareness. Education: Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. Other: Ability to travel nationally/internationally as required. Valid driving license per country requirements, as applicable 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.

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your Role at Baxter: As a skilled Senior Manager, Clinical Quality Assurance, you will lead our clinical quality assurance efforts across Baxter. You will be responsible for proactively anticipating regulatory changes, ensuring compliance with industry best practices, and driving process improvements in clinical trials for all products - pharmaceuticals and medical devices. You'll bring a strong understanding of clinical regulations, quality management systems, and industry trends. What You'll Be Doing: Clinical Quality Assurance Leadership: Independently lead the development and implementation of clinical quality assurance strategies to ensure compliance with regulatory requirements Proactively anticipate the horizon of regulations and ensure that current GCP/Clinical Trial practices reflect current and future industry practice Provide clinical quality leadership, expertise, and support to Clinical Operations and the CMSO Provide subject matter expertise to the MA teams and leadership regarding clinical quality matters with respect to the current regulatory landscape Review and approve GQPs involving Human Subjects Research and Human Clinical Research Quality Assurance Activities: Plan and monitor quality activities for Clinical Trials, including all phases of clinical trials and post-market clinical studies Conduct sponsor clinical sites and vendor assessments as required Lead internal and/or regulatory audits of Clinical Trials and/or Clinical Operations Handle clinical escalations, non-conformances, or CAPAs related to Clinical Trial operations and/or Clinical vendors Manage New Supplier Request process for Clinical vendors Consult and approve risk-based approaches developed by Clinical Leadership for human clinical research sponsored by Baxter Assess impact of Field Actions on ongoing or planned clinical trials Regulatory Compliance: Interpret clinical regulations and provide guidance to Clinical Operations Ensure compliance with regulatory requirements, including GCP, FDA & EMEA regulations, and other relevant standards Serve as an interface for inspections, audits, and inspections relating to GCP compliance Quality Metrics and Risk Management: Assist in collecting quality metrics for adequate study oversight Identify and assess regulatory and quality risks in activities and processes as necessary according to regulatory agency rules and guidelines and Baxter quality practices Process Improvements and Initiatives: Drive process improvements and initiatives in support of continuous process improvements Maintain current and leading-edge expertise in quality management systems and quality techniques Stay up-to-date with related quality legislation and compliance around clinical trials Travel to regulatory agencies, industry conferences, and other external meetings as required (not expected to exceed 25%) Your Team: As the Senior Manager, Clinical Quality Assurance, you will report directly to the Associate Director, Clinical Operations, Operations & Governance, Worldwide Medical & Regulatory and work collaboratively with cross-functional teams to ensure the delivery of high-quality clinical data and reports. Your Location: The role is located at our global corporate headquarters in the greater Chicago, IL area northern suburb of Deerfield. Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change. Alternatively candidates residing anywhere in the US will also be considered. What You'll Bring: • Bachelor's degree in a life science or related field is required • Minimum 5-7 years of experience in clinical quality assurance, regulatory affairs, or a related field • Experience in managing clinical quality assurance teams and developing quality management systems • Experience in Clinical Trials, Phase 0 - IV. • Experience in Pharmaceutical and Medical Device Clinical Trials • Experience performing laboratory, GCP, GMP audits a plus. • Strong knowledge of clinical regulations, quality management systems, and industry trends • Ability to work independently and drive clinical quality assurance strategy and plans • Experience with clinical data management systems and processes • Strong leadership and communication skills • Ability to analyze and interpret complex data • Experience with quality management systems and auditing #LI-JR1 We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $136,000 - $187,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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 an experienced nonclinical drug development professional to serve as a Principal Scientific Advisor within our Discovery and Safety Assessment business units. The Scientific Advisory Services team is hiring an experienced professional with expertise in establishing effective scientific and regulatory strategies to advance new medicines through the various stages of the development process. This position provides opportunity for independent scientific guidance and leadership roles within project teams and functional areas across the organization, with an emphasis on providing innovative advice on nonclinical (pharmacology and toxicology) drug development programs across a broad spectrum of drug modalities. This individual will work closely with current and potential clients and internal Charles River functional groups to design robust and scientifically sound nonclinical drug development programs. The person may act as the scientific leader for cross-functional teams for integrated discovery and safety programs. When appropriate, the individual may perform gap analyses, support due diligence procedures, and perform scientific review of discovery and/or safety assessment data or reports. This role provides for recognition throughout the company as a subject matter expert in one or more therapeutic area(s) or class(es) of therapeutic products. Successful individuals have knowledge of domestic and international regulatory expectations and requirements; and can provide intellectual input in determining the appropriate discovery and nonclinical safety assessment strategy for complex and novel products, including advanced medicinal products. There will be opportunities to support department leadership regarding strategy and recruitment. More broadly, one will work closely with Business Development, Client Services, Account Management, Marketing, and Operations by ensuring that clients' business and scientific needs are understood and efficiently addressed. Scientific Advisory Services team members are located throughout the US and Europe and work virtually from their home offices and/or within Charles River discovery/safety assessment sites. This position offers a stimulating and dynamic work environment, flexibility in work schedule, and opportunities for professional development and leadership growth. This position will mainly support potential clients generally located in the Eastern Time Zone. Position is remote. Can work from US or Europe. **Job Qualifications** The following are minimum requirements related to the Principal Scientific Advisor position. + Education: Master's degree or PhD in relevant discipline (toxicology, pharmacology, biology, immunology, etc.). + Experience: + Minimum 15 years' experience in pharmaceutical/biotech sector, nonclinical contract research or consulting including at least 10 years nonclinical drug development experience. + Must have direct experience in regulated toxicology and drug development. + Prior experience in program management and/or Pharm/Tox Program Leadership is considered useful. + Certification/Licensure: DABT, DACVP or European Registered Toxicologist preferred. + Other: + Applied understanding of regulatory requirements for the conduct of nonclinical safety assessment studies including Testing Facility SOPs and the Good Laboratory Practices (GLPs). + Deep understanding of relevant regulatory guidance documents is essential. + Demonstrated leadership skills in support of intra- and interdepartmental initiatives, client/external interactions, and business development. + Proficiency in the use of standard software including Microsoft Excel, Word, PowerPoint, etc. and standard laboratory calculations. Compensation Data The pay range for this position is $200K - $225K USD annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. **About Corporate Functions** The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement. **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 *************** 231309

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. Parexel is hiring an FSP Consultant, Advanced Analytics: Meta-Analysis (HTA Statistician) to work remotely. Must be able to accomocated East Coast/CET hours. The ideal candidate will have key experience in NMA/Evidence Synthesis, Survival analysis, and HTA experience. Location: US - Remote | Employment Type: Full-Time Job Purpose The Consultant, Advanced Analytics: Meta-Analysis contributes statistical capabilities and methodological leadership at all stages of projects, from planning to completion. The role involves working with junior team members to design, develop, and deliver client solutions across multiple projects-leveraging competencies in statistical theory, data analysis and interpretation, regression analysis, systematic review, and evidence synthesis methodologies. The individual must have a Master's or Doctoral Degree in Health Economics, Health Policy, Statistics, Biostatistics, Mathematics, or other quantitative fields. Proficiency in data analytics and statistical software/tools such as WinBUGS, R, Stata, Python, and SAS is required. Key Accountabilities Provide expert input on the design of clinical development programs to ensure Access/HTA evidence needs are considered within global development and commercialization strategies. Identify evidence gaps, possible data sources, and design and implement robust evidence-generation plans. Ensure Access/HTA evidentiary activities are strategically aligned with other functions within Global Access and the wider organization (affiliates, Product Development, commercial, etc.). Plan and conduct statistical analyses of clinical trials and other relevant data sources and develop supporting technical documentation for statistical analyses and economic models. Interpret and communicate the findings of analyses and work closely with affiliates to incorporate global statistical and health economics input into their local reimbursement applications. Lead or contribute to cross-functional teams within a matrix structure and actively contribute to the development of methodologies and continuous improvement within the Evidence Chapter. Keep up to date with the changing Access/HTA landscape and academic research to ensure current access trends and methodologies are incorporated into evidentiary plans and build relationships with relevant external statistics, health economics, Access/HTA, and policy experts. Additional Responsibilities The Consultant is responsible for ensuring that all assigned projects are conducted efficiently and that quality and client satisfaction are maximized-ensuring project direction and deliverables meet objectives and client needs. Consultants are expected to guide Senior Associates and Associates in their daily duties and flag any areas of acute training needs to their line managers. Supported by senior staff and Business Development partners, the Consultant is responsible for maintaining client relationships on their projects. Candidates will be part of multi-disciplinary research teams and will provide statistical expertise and methodological leadership at all stages of projects from planning to completion. Duties may include: Preparing network meta-analysis protocols Reviewing data extracted from systematic literature reviews Conducting feasibility assessments Generating network diagrams Critically assessing study heterogeneity Conducting network meta-analysis Assisting with interpretation and dissemination of findings The candidate is also expected to support thought leadership and innovation objectives in advanced analytics, including but not limited to: Pairwise meta-analysis Mixed treatment comparison Indirect treatment comparison Network meta-analysis Match-adjusted indirect treatment analysis Meta-regression Single-arm trial analysis Simulated treatment comparison Surrogate outcome assessment Skills & Qualifications Master's or Doctoral-level degree in applied statistics, health economics, or related quantitative fields. Minimum of 3 years of hands-on experience in the pharmaceutical industry, consultancy, Access/HTA/reimbursement agency, or academic institution (pharma affiliate experience is a plus). In-depth knowledge of Access and HTA, clinical research and development methods, and international payer evidence requirements. Skilled in research design and statistical methods, such as Generalized Linear Models, Survival Analysis, Network Meta-Analysis, and Bayesian statistics. Proficient in R and GitLab (experience with SAS, Python, WinBUGS, JAGS, or other relevant statistical software is a plus). Strong strategic, collaboration, and communication skills; excellent organization, planning, and prioritization abilities; ability to meet tight deadlines; and strong written and verbal communication skills in English. 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.

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. Parexel has an opportunity for a Consultative Sales Director to join our Emerging Biopharma team to cover the San Francisco and Pacific Northwest territories. The Consultative Sales Director is responsible for identification, targeting, and securing new business across all SBUs, through professional, consultative, proactive sales activities directed at decision-makers and decision influencers. The CSD drives the entire sales process in close collaboration with the Solutions Consultants and Commercial Operations, and ensures smooth transition to delivery. The CSD will execute on their territory/Account sales strategy to gain market share and build high levels of customer satisfaction and loyalty. New Business Acquisition Actively and aggressively prospect and leverage potential new business opportunities within specified customer account(s) Analyze and prioritize potential opportunities and develop strategic sales plans for each target account Ensure appropriate strategy/solution is proposed to customer Lead proposal strategy and development in collaboration with Business Operations to ensure client needs are addressed and resourcing/pricing is appropriate to win the business and meet margin targets Work with Solutions Consultant and Finance to agree on appropriate pricing strategy Educate team participants in bid pursuit on customer culture, operational needs/methods and sales techniques needed to close the sale Adapt successful strategies and tactics to meet market demands and financial targets Client prospecting Actively maintain territory account plan with break-in strategies Understand the clients' development and commercial strategy, product development portfolio, and pain points Project confidence and expertise in the approach and engagement with key decision makers Proactively engage clients across all key functions up and down the sponsor organization; maintain high visibility within client organization and become the trusted advisor Develop a strong understanding of clients' organizational structures and key stakeholders Anticipate client questions; uncover clients' unique needs and become the focal point for discussing, representing and selling Parexel's integrated solutions across all SBUs Competition: Collaborate with marketing, inside sales, Solution Consultants, and commercial operations to obtain thorough knowledge of the competitive landscape and high priority opportunities Aggressively pursue awareness of competitive activities, positioning and pricing, which includes specific reasons for awards and non-awards Parexel: Maintain solid knowledge of all Parexel services and value propositions for appropriate cross-selling opportunities Collaborate with Solution Consultants to identify appropriate, integrated solutions Client Relationship Management Ensures appropriate hand-off to delivery team liaising with Project Integrator Role or Project Leader to transfer knowledge on client needs and expectations Maintain close relationships with delivery teams for identification of new opportunities to ensure account growth Skills: Proven sales track record of achieving/surpassing sales goals Ability to work independently and as team player; including complex, dynamic teams Excellent business/industry awareness and a thorough understanding of industry trends and impact on the business Strong consultative skills Solid understanding of commercialization and the principles of drug discovery and development Excellent analytical skills in assessing and interpreting customer business data Demonstrated ability to build relationships and to communicate at senior management level Demonstrated ability to influence others internally and externally Ability to establish and maintain effective working relationships with coworkers, managers, clients and customers Ability to maintain demanding timelines Adaptability and flexibility to changing priorities Demonstrated ability to work creatively in a fast-paced environment Attention to detail and ability to work simultaneously on multiple priorities Willingness to travel 50% of time as client needs dictate Knowledge and Experience: Multiple years previous experience in B2B sales role, preferably in a CRO, Life Sciences Company or Consulting background specializing in Life Sciences Education: BS degree required. Advanced degree preferred. 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.

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your role at Baxter The Associate Director, Clinical Audits is responsible for leading the Clinical Audit Program, collaborating with clinical operations, suppliers/vendors, and Baxter's functions/businesses. Grow clinical auditing capability, utilizing expertise, knowledge and experience of best-practice methodologies and practices in industry, working closely with global quality compliance partners to ensure a robust Clinical Audit plan and strategy is in place. What you'll be doing * Develop and maintain the annual risk based Clinical Audit schedule following global Audit Program, and external requirements. * Lead the preparation of, conduct, and reporting of Clinical Audits including clinical investigator sites, clinical research organizations, and internal processes/systems. Present and report Audit results concisely and logically both verbally and in writing to senior global quality compliance leadership. * Review Clinical Audit observation responses and ensure Corrective and Preventive Action (CAPA) plans adequately address observations, root causes, and effectiveness checks. * Maintain responsibility for and oversight of Clinical Audits conducted by contractors, when applicable. This includes identifying suitable Clinical Audit consultants, working with Procurement to establish contracts and providing relevant training in accordance with company procedures. * Interacts and develops relationships with clinical research vendors' quality leaders through audits, project teams, and establish one-on-one relationships. * Subject Matter Expert/Point of Contact to provide expertise and knowledge to less experienced Auditors, business partners and company entities on clinical processes. Provide clinical compliance expertise including supporting the generation of clinical Audit metrics, creation and revision of SOPs. * Participate in external inspections in core and supporting roles, assisting with the preparation and delivery of appropriate training materials, advising and contributing to auditee coaching. * Identify potential issues and risks with impact on clinical trials or processes and ensure communication. What you'll bring * A degree in life science or engineering discipline is required; an advanced degree is preferred. * 10+ years' experience working in pharmaceutical and/or medical device industries, with 5 of these years as a Lead Auditor. * 2 years' experience with Regulatory Inspections Management (e.g. MHRA, FDA, EU inspections) * 1 -5 years program and people management experience, working in a matrix organization. * Demonstrated ability to work as a leader with strong communication and relationship building skills. * ASQ certification, IRCA or other relevant auditor certification a plus. * Advanced knowledge of and experience with clinical regulations, and relevant standards (e.g., FDA, ISO, ICH, EMA, MDR, IVDR GDPR) with practical application and execution of GCP requirements. * Clinical Quality assurance medical device and/or pharmaceutical experience, with significant medical device experience in clinical research highly preferred. * Advanced knowledge and understanding of clinical development programs and clinical trial processes as well as quality management systems and quality control tools. * Knowledge of processes related to Clinical Data Management and Biostatistics functions. * Ability to collaborate and engage with all leadership levels through written and verbal communication. * Ability to travel up to 50% of the time and accommodate time zone differences in case of remote audits. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $152,000 - $209,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. #LI-SL1 US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. #LI-Remote