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Job Details Temecula - Temecula, CA Flower Mound - Flower Mound, TX; Kernersville - Kernersville, NC Fully Remote $120000.00 - $150000.00 SalaryDescription The Security Administrator is a key member of FFF Enterprises' Information Security team, responsible for strengthening and maintaining the company's overall security posture. This role oversees the evaluation, testing, and documentation of security controls while designing and implementing strategies to protect the organization's digital and physical assets against unauthorized access, data breaches, disruption, or other threats. Partnering closely with Information Security leadership, IT teams, and business stakeholders, the Security Administrator ensures security principles are embedded across all technology systems and processes. This position provides expert guidance on risk mitigation and regulatory compliance, supporting FFF's mission to protect sensitive data, enable operational resilience, and maintain trust with patients, partners, and the healthcare community. Essential Functions and Duties Information Security & Access Management: Develop, implement, and enforce policies to govern access to company resources, including the Office 365 environment, for both human and machine identities. Ensure the security, integrity, and compliance of Active Directory, Entra ID, Okta, and other cloud-based identity providers (IDPs). Configure and manage Microsoft Purview tools such as Data Loss Prevention (DLP), sensitivity labels, and retention policies to protect sensitive data and ensure regulatory compliance. Oversee and integrate advanced identity technologies, including Privileged Access Management (PAM), Identity Governance & Administration (IGA), User and Entity Behavior Analytics (UEBA), Cloud Infrastructure Entitlement Management (CIEM), Customer Identity and Access Management (CIAM), and Network Host Integration (NHI). Manage centralized user security and entitlement reviews, including recurring certifications and related audit processes, to ensure access is appropriate and compliant. Assess and mitigate organizational risks associated with user access, data access, and identity governance, providing recommendations for improved security posture. Establish, document, and maintain standards, policies, and procedures related to identity management and infrastructure. Provide guidance, education, and training to IT staff and business users on identity and access management (IAM) policies, tools, and best practices to promote consistent and secure practices across the organization. Security Control Assessment: Conduct comprehensive security audits and risk assessments of systems, infrastructure, and identity environments to identify vulnerabilities and compliance gaps. Develop and deliver detailed reports that clearly outline audit findings, highlighting areas of strength, potential risks, and opportunities for process improvement. Provide strategic, consultative guidance to cybersecurity governance and infrastructure teams to enable informed decision-making and effective prioritization of resources. Facilitate the implementation of appropriate control measures aligned with the organization's risk appetite to proactively monitor, mitigate, and manage cybersecurity threats. Ensure identified risks are remediated in a timely manner and that all residual risks are accurately documented, tracked, and reported to leadership for ongoing oversight. Security Event & Incident Response: Continuously monitor system logs, SIEM tools, network traffic, user activity, and endpoint behavior to identify unusual or suspicious activity that may indicate potential threats. Collaborate with internal teams and external partners to manage, contain, and report security incidents, ensuring clear communication and rapid response. Participate in incident response activities during non-standard work hours when required to mitigate urgent threats and maintain business continuity. Evaluate the performance and effectiveness of Managed Detection and Response (MDR) solutions, recommending enhancements to improve threat detection, response speed, and overall cybersecurity resilience. General Responsibilities: Adheres specifically to all company policies and procedures, Federal and State regulations, and laws. Display dedication to position responsibilities and achieve assigned goals and objectives. Always represent the Company in a professional manner and appearance. Understand and internalize the Company's purpose. Display loyalty to the Company and its organizational values. Display enthusiasm and dedication to learning how to be more effective on the job and share knowledge with others. Work effectively with co-workers, internal and external customers and others by sharing ideas in a constructive and positive manner; listen to and objectively consider ideas and suggestions from others; keep commitments; keep others informed of work progress, timetables, and issues; address problems and issues constructively to find mutually acceptable and practical business solutions; address others by name, title, or other respectful identifier, and respect the diversity of our work force in actions, words, and deeds. Comply with the policies and procedures stated in the Injury and Illness Prevention Program by always working in a safe manner and immediately reporting any injury, safety hazard, or program violation. Ensure conduct is consistent with all Compliance Program Policies and procedures when engaging in any activity on behalf of the company. Immediately report any concerns or violations. Other duties as assigned. Qualifications Education, Knowledge, Skills, and Experience Required Education: Bachelor's degree in Management Information Systems, Computer Science, Information Technology, or a related field, or an equivalent combination of education and directly related professional experience that provides the knowledge, skills, and abilities necessary to perform the role effectively. Preferred Education: Advanced degree (Master's) in Information Security, Cybersecurity, Information Technology, or a related discipline. Industry-recognized security certifications such as CISSP, CISM, CISA, CompTIA Security+, or Microsoft Certified: Cybersecurity Architect Expert. Specialized training or coursework in cloud security, identity governance, or compliance frameworks (e.g., HITRUST, HIPAA, GDPR). Required Knowledge: Comprehensive expertise in data security, access management, and identity governance concepts, tools, and best practices. Strong proficiency in securing multiple computing platforms, with a primary focus on Windows and Linux operating systems. Foundational understanding of network security principles, including firewalls, network segmentation, and intrusion prevention. Knowledge of incident response processes, including real-time system monitoring, analysis, and threat mitigation techniques. Ability to translate complex security risks into clear business impacts, enabling informed decision-making by technical and non-technical stakeholders. Preferred Knowledge: Understanding of risk management practices and security control audit methodologies, including implementation and evaluation techniques. Familiarity with regulatory and compliance frameworks such as HITRUST, PCI, HIPAA, SOX, GDPR, and CPRA, with the ability to apply these standards to security operations. Knowledge of cloud platform security, with a strong preference for experience working with Google Cloud Platform (GCP) or Microsoft Azure environments. Proficiency in managing advanced security tools, including file integrity monitoring (FIM) systems, Data Loss Prevention (DLP) solutions, and Microsoft Active Directory group policies. Experience with emerging Microsoft technologies, including Copilot Studio, PowerApps, Microsoft Graph API, data connectors, and associated integrations to optimize automation and identity management. Required Experience: A minimum of five (5) years of experience in network and system administration, or a combination of three (3) years of experience in network/system administration and two (2) years of experience in cybersecurity or control audit/risk management. Demonstrated experience applying change management and project management principles to IT and security initiatives. Hands-on expertise with Microsoft 365 services, including Entra ID, SharePoint, Teams, Active Directory, and Microsoft Purview. Proven ability to implement, manage, and optimize data protection methods, including encryption, access controls, and security monitoring tools. Preferred Experience: Five (5) or more years of progressive experience in cybersecurity, including control audits and risk management, or a total of ten (10) or more years of combined experience across cybersecurity and network/system administration. Proven experience integrating emerging access control technologies, such as Single Sign-On (SSO), Data Loss Prevention (DLP), and Role-Based Access Control (RBAC), within multi-operating system (multi-OS) environments. Experience leading or conducting control audits aligned with industry compliance standards and best practices. Demonstrated expertise in securing cloud-based data and identity resources, with an emphasis on scalability and regulatory compliance. Required Skills: Strong organizational and prioritization abilities, with exceptional attention to detail and accuracy. Excellent verbal and written communication skills, including the ability to convey complex technical concepts to both technical and non-technical audiences. Demonstrated ability to work independently while fostering collaboration within cross-functional teams. Proven decision-making and problem-solving skills, with the capacity to analyze complex situations and determine effective solutions. Ability to balance strategic vision with tactical execution, aligning day-to-day activities with long-term organizational goals. Resilience to remain calm and effective under pressure, including high-stakes or time-sensitive situations. Commitment to integrity, accountability, and continuous improvement, with a focus on advancing security practices and outcomes. Dedication to staying current with evolving cybersecurity threats and emerging technologies, applying new knowledge to enhance the organization's security posture. Preferred Skills: Advanced analytical and investigative abilities, with experience leveraging data-driven insights to identify vulnerabilities and recommend targeted solutions. Proficiency with security automation tools and scripting languages (e.g., PowerShell, Python) to streamline processes and improve operational efficiency. Experience mentoring or training team members, fostering knowledge sharing and the adoption of best practices across technical teams. Strong presentation and executive communication skills, with the ability to influence leadership decisions and drive alignment on security initiatives. Cross-functional leadership experience, collaborating with business stakeholders, IT teams, and external partners to deliver enterprise-wide security improvements. Familiarity with threat intelligence platforms and advanced threat-hunting techniques for proactive risk detection and mitigation. Strategic project management capabilities, including planning, execution, and evaluation of large-scale cybersecurity initiatives. Physical requirements Vision, hearing, speech, movements requiring the use of wrists, hands and/or fingers. Must have the ability to view a computer screen for prolonged periods and the ability to sit for extended periods. Must have the ability to work the hours and days required to complete the essential functions of the position, as scheduled. Must have the ability to lift and maneuver items of at least 20 lbs. Must have the ability to travel occasionally. Working condition include normal office setting. Mental Demands Learning, thinking, concentration and the ability to work under pressure, particularly during busy times. Must be able to pay close attention to detail and be able to work as a member of a team to ensure excellent customer service. Must have the ability to interact effectively with co-workers and customers, and exercise self-control and diplomacy in customer and employee relations' situations. Must have the ability to exercise discretion as well as appropriate judgments when necessary. Must be proactive in finding solutions. Direct Reports No EEO Statement FFF Enterprises and Nufactor are an equal opportunity employer and prohibits discrimination and harassment based on the following characteristics: race, color, religion, national origin, physical or mental disability, gender, age (40 years and over) qualified veteran and any other characteristic protected by state or federal anti-discrimination law covering employment. These categories are defined according to Government Code section 12920. The Company prohibits unlawful discrimination based on the perception that anyone has any of those characteristics or is associated with a person who has or is perceived as having any of those characteristics.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply. **Purpose:** The Legal Partner, R&D Transactions is responsible for providing legal support and legal services in relation to certain R&D legal transactions of the Research, Technology and Manufacturing (T&M), Development, Medical Affairs, and Rx+ functions. The position holder also provides legal support and advice for other functions where required. **Essential Job Responsibilities:** + Providing practical, timely, proactive, strategic, high quality legal services for the Research, T&M, Development, Medical Affairs, and Rx+ functions on R&D transactional matters taking into account the global objectives of the organization and the unique and varying global, local and regional legal and regulatory requirements in a risk-balanced manner in order to effectively minimize and mitigate risk + Providing legal and strategic support for a broad range of R&D transactions for Research and managing the strategic drafting, negotiating, and consummating a broad range of complex agreements in support of Research, including research collaborations and alliances, consortiums, sponsored research, material transfers, research licenses, HTS library exchange, consulting services, research services, CRO services, advisory boards and councils, data sharing and data licensing, investigator-initiated studies, regulatory and quality agreements + Providing legal and strategic support for a broad range of R&D transactions for T&M, including supply agreements, manufacturing contracts, collaborations, service agreements, and other contracts. This may include but is not limited to support to business clients on (i) contract drafting and negotiations with potential business partners and collaborators and (ii) strategic projects and key initiatives of the T&M function + Providing legal and strategic support for a broad range of R&D transactions for Development and managing the strategic drafting, negotiating, and consummating of a broad range of complex agreements in support of Development, including agreements for clinical trials, assay development, companion diagnostics, expanded access, compassionate use, patient recruitment, informed consents, non-interventional studies, sponsorships and grants, advisory boards, data sharing and data licensing, investigator-initiated trials, and regulatory, quality, and pharmacovigilance agreements + Providing legal and strategic support for a broad range of transactions for Medical Affairs and managing the strategic drafting, negotiating, and consummating of a broad range of complex agreements in support of Medical Affairs, including investigator-sponsored research agreements and escalations related thereto, Astellas-sponsored medical affairs study agreements, collaborative research, and CRADAs + Providing legal and strategic support for a broad range of transactions for Rx+ and managing the strategic drafting, negotiating, and consummating of a broad range of complex agreements in support of Rx+ and medical devices, including consulting agreements, confidentiality agreements, service agreements, master services agreements, development agreements, and clinical trial agreements + Providing updates to management and business clients on changes in legal developments affecting the pharmaceutical industry, especially in the research and development fields, and the innovative new technologies and coordinating with other leaders in the Legal Functional Unit, as may be appropriate + Identifying, participating in, and contributing to contract enhancement initiatives for business clients, including by suggesting, preparing, and reviewing new templates of contracts, check lists, guidance, etc. + Aligning, coordinating, and working closely with the members of the Legal Transactions Tower and other members of the Legal Functional Unit and the GC & CECO Division + Retaining, supervising, and directing outside counsel effectively, and efficiently managing legal expenses consistent with approved global budget, coordinating closely with the Legal Team Lead, R&D Transactions + Other projects as may be requested by the Legal Team Lead, R&D Transactions + Overnight travel, including international travel, as needed **Qualifications Required:** + Bachelor of Laws (LL.B.), Juris Doctor (JD), Master of Laws (LL.M.) or equivalent + At least 5-7 years of experience working in a law firm or pharmaceutical legal department **Preferred:** + Prior legal experience handling diverse and complex transactions for a company in the pharmaceutical, medical device, and/or biotechnology industry + Science degree or background/experience in chemistry/biology is an advantage + Understanding of the legal issues relating to pharmaceutical, biotechnology, and/or medical device businesses or affecting the pharmaceutical or biotechnology industry. This may include understanding of patent, trademark or copyright licensing, joint research and development, regulatory processes for medical devices, over the counter drugs or prescription drugs, anti-kickback, fraud and abuse, and anti-bribery and anti-corruption + Bar membership in state/jurisdiction of practice **Working Environment:** + At Astellas, we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines **Salary Range** : $157,500 - $247,500 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** : + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program **\#LI-CH1** Category Legal Transactions Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

The Future Talent Program offers co-ops lasting up to 6 months that will include one or more projects. These opportunities within our Research & Development Division serve as a platform for significant personal growth, allowing you to gauge whether our company aligns with your long-term objectives. The Quantitative Biosciences Cellular Pharmacology & Lead Discovery team is looking for a highly talented and motivated student to join our ranks. Collaborating closely with experienced pharmaceutical industry scientists, the chosen candidate will contribute to the discovery and advancement of novel medicines for cancer and cardiometabolic disorders. At the heart of this role lies the execution of critical cellular assays to evaluate and characterize preclinical therapeutic candidates. The successful candidate will: Learn about different cellular assays used in drug development and how to leverage laboratory automation to improve robustness and increase throughput Execute cellular assays to support compound screening and mechanism of action studies Evaluate and optimize new assay technologies and methods Engage with industry-standard data analysis tools and record keeping, including electronic lab notebooks and analysis software Communicate data progress during internal meetings; deliver a verbal presentation at the completion of training; participate in scientific exchange with our Company scientists We value open communication, creative-thinking, strong teamwork, and rigorous scientific exploration. If you are a highly motivated team player with enthusiasm for learning about new techniques and drug discovery, we invite you to apply. Required Education & Experience: Candidates must be currently enrolled in a full-time degree program in biology, biochemistry, or a related scientific discipline and have completed at least 2 years of studies toward BS/BA or at least 1 year towards Master's/PhD by the start of the co-op Candidates must be available to work full-time for 4-6 months starting after January 2026 Candidates must have excellent verbal and written communication skills and a demonstrated record of strong academic achievement Candidates must have proven ability to work independently in a multi-functional, team-oriented environment Preferred Experience & Skills: Candidates should have previous laboratory experience with cell biology techniques and relevant plate-based assay detection technologies Candidates should have hands-on experience with aseptic technique and good cell culture practice Candidates should have a keen interest in scientific exploration and drug discovery research Candidates should be self-motivated and detail-orientated with excellent record keeping and organizational skills Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company. Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Salary range: The salary range for this role is $39,600.00-$105,500.00 USD FTP2026 RL2026 Required Skills: Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Intern/Co-op (Fixed Term) Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): Yes Job Posting End Date: 11/3/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Responsible for conducting retrospective medical reviews to assess medical record documentation and monitoring submitted codes on claim/encounters for Medicare Risk Adjustment. How will you make an impact & Requirements Location: Must reside in the Los Angeles region. This is a remote position that requires regular travel within the LA area. Responsible for conducting retrospective medical reviews to assess medical record documentation and monitoring submitted codes on claim/encounters for Medicare Risk Adjustment. Primary duties include, but are not limited to: Conducts retrospective medical record and claims review to assess medical record documentation practices and accuracy/sufficiency of policies and procedures. Verifies accuracy/appropriateness of submitted diagnosis codes based on medical record documentation looking at both ways 1) appropriate detail in the medical record is not captured in what is reported, and 2) when reported information is not supported by details in the medical record. Identifies and recommends coding best practices to address unsupported additions/deletions, inconsistencies/discrepancies. Updates and develops policies and procedures and training/educating collateral to reflect best practices. Conducts on-going review, monitoring and communications to promote and ensure adherence to established protocols and best practices. Reviews documentation of well visits (annual well visits and other routine and preventative visits) including the use of appropriate modifiers for HEDIS scoring accuracy. Conducts on-going review of medical records/practice notes to validate improvement, identify any new/additional opportunities to improve medical record-keeping, code more accurately, ensure on-going accuracy of submitted codes and accurate risk scoring and continues to verify coding accuracy and completeness to ensure compliance. Requirements Requires minimum of 2 years experience coding all types of medical records (including Medicare Risk Adjustment) in a physician practice setting or large group practice. Current Certified Professional Coder certification (CPC, CPC-H, CCS, or CCS-P) required. Additional experience in procedural clinical coding preferred. Clinical experience or background (e.g. RN, LPN, foreign medical graduates) preferred. Must reside in the Los Angeles region and be able to travel regularly throughout the LA area. Compensation: $90,160K - $112,700K & bonus eligible

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . Remote work within the continental US may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote or hybrid work are encouraged to apply. **Purpose:** The XTANDI Commercial Brand Strategy Lead is responsible for leading and driving the development and implementation of the XTANDI US Strategy and connection to tactical execution through leadership and close collaboration with the rest of the Brand Team. They will be responsible for the leading the Brand Planning process, Competitive Readiness and Life Cycle Management plans, working closely with key functional partners and the Commercial Head to understand key brand insights and performance factors, helping to mobilizing the team to address those insights, and other critical strategic projects Additionally, this colleague will be a key member of internal global and alliance teams. The Commercial Lead reports directly to the XTANDI Commercial Head and sits on the US XTANDI Marketing Leadership team and will be a critical role in driving the success of the business. This colleague is responsible for ensuring and modelling strong cross-functional alignment in the Brands@Center Operating Model and ensuring execution of strategy with key partners, especially other members of the brand team, alliance partner, Market Access, Global Marketing, CI, Sales, Training, Regulatory, Legal, Medical Affairs, and agencies. Specific responsibilities will evolve based on the needs and lifecycle of the brand, and competencies required on specific projects. **Essential Job Responsibilities:** + Leading the development of the US Strategic Plan and Tactical Plan and approved budget across the XTANDI alliance and in alignment with global colleagues + Leading the Life Cycle Management plan for XTANDI across cross functional and alliance partners and ensuring strong alignment and execution + Development and implementation of competitive readiness plans + In collaboration with Commercial Insights Lead, to lead the team in actioning against key insights and market events + Lead development and completion of executive reporting (QBR, MBR, IR) and forecasting with Commercial Head and other cross functional partners + Together with the Commercial Head, this role will be a key day-to-day contact for brand leadership with our alliance partner: member of XTANDI Joint Commercialization Committee. + As key member of XTANDI Marketing Leadership Team, lead and implement other initiatives to support team and overall brand and/or enterprise as assigned + Ensure all work is completed in an ethical and compliant manner **Quantitative Dimensions** + Financial and brand performance + Marketing strategy, management, and execution + Customer satisfaction and experience - enabling strong, business-centric, collaborative relationships with customers, both internal and external + Driving business performance through effective cross-functional team dynamics and collaborative initiatives + Contributes with an enterprise mindset by leveraging and sharing best practices across the organization + Efficient use of resources including management of vendors, negotiation for services both internally and externally, and monitoring of budgets **Organizational Context** This individual will report to the US Commercial Head, XTANDI. This position will need to fully develop working relationships with external partners and internal colleagues from other departments (including global, medical affairs, market research, legal, and regulatory) as well as multiple functions within the alliance partner. Frequent contact and collaboration with Commercial Heads and/or associated senior level colleagues across functions is expected. This role requires high levels of collaboration for success and will need to be consistently demonstrated through the sharing of ideas that leads to creative solutions. **Qualifications** **Required:** + Bachelor's Degree required + 10+ years of relevant pharmaceutical experience, including a breadth of U.S. brand marketing experience + Strong understanding of US market dynamics, regulatory influences, compliance constraints, market access, and managed care influences + Leverages wide range of data to measure, monitor, assess, report and drive team productivity and results + Proven track record of meeting or exceeding goals and demonstrated ability to deliver results + Strong communication and interpersonal skills + Proven ability to use analytical skills and critical thinking to diagnose business issues and adjust plans accordingly + Ability to create, implement and iterate impactful action plans + Proven capabilities to influence without authority and effectively lead cross-functional work teams/projects + Ability to present complex issues to higher level management and contribute to high level presentations + Ability to travel up to 30% **Preferred:** + Cross functional commercial experience (sales, payer, global marketing, strategic planning) + Master's degree + Experience leading people + Customer facing experience + Experience working in a partnership / co-promotion + Significant experience in Oncology and specifically prostate cancer **Salary Range** **:** $170,450 - 267,850 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** **:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-TD Category XTANDI Brand Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Description About Orsini Specialty Pharmacy "Providing compassionate care since 1987, Orsini is a leader in rare disease and gene therapy pharmacy solutions, built to simplify how patients connect to advanced medicines. Through our comprehensive commercialization solutions including a nationwide specialty pharmacy, patient services hub, home infusion and nursing network, and third-party logistics provider, we work with biopharma, providers, and payors to ensure No Patient is Left Behind™." Our Mission Orsini is on a mission to be the essential partner for biopharma innovators, healthcare providers, and payers to support patients and their families in accessing revolutionary treatments for rare diseases. Through our integrated portfolio of services, we seek to pioneer comprehensive solutions that simplify how patients connect to advanced therapies while providing holistic, compassionate care so that No Patient is Left Behind™. LIVE IT Values At the heart of our company culture, the Orsini LIVE IT core values serve as guiding principles that shape how we interact with each other and those we serve. These values are the driving force behind our commitment to excellence, collaboration, and genuine care in every aspect of our work. Leading Quality, Integrity, Valued Partner, Empathy, Innovation, Team-First Salary Range: $19-23 This position will be responsible for the data-entry of new enrollments, locating any and all lines of eligibility for the patients. Resolving rejected pharmacy claims and documentation of the steps taken in the enrollment process for each enrollment. Required Knowledge, Skills & Training 1+ years of experience in pharmacy related data entry. 1+ years of submitting pharmacy claims and resolving rejections. Knowledge of medical insurance. National Technician Certification, preferred Pharmacy Technician License Ability to multitask. Ability to work well in a fast-paced working environment. Attention to detail. Excellent written and verbal communication skills. Candidate must be able to type 40 WPM and maintain accuracy. Essential Job Duties Enter patient enrollment information into pharmacy operation systems. Submit eligibility requests in available portals to find insurance coverage information for new enrollments. Troubleshoot pharmacy claims and resolve the rejections for both new and refill patients. Document all findings in our operating system(s). Partner with the other teams in Admissions and within the pharmacy and any other business partners to expedite the referral process. Other related duties as assigned. Employee Benefits BCBSL Medical Delta Dental EyeMed Vision 401k Accident & Critical Illness Life Insurance PTO, Holiday Pay, and Floating Holidays Tuition Reimbursement

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit ******************* or follow MMS on LinkedIn. This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities: Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator's Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs) Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports) Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC Demonstrated ability to lead others to complete complex projects Ability to complete documents according to sponsor's format, processes, and according to regulatory guidelines Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment Organizational expert within the nonclinical subject area Excellent written/oral communication and strong time and project management skills Ability to attend regular team meetings, lead client meeting and CRMs Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP) Requirements: BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control Knowledge of GLP, ICH guidelines, and applicable regulatory requirements 2+ years of pharmaceutical regulatory nonclinical writing experience Strong writing and analytical skills Proficiency with MS Office applications. Hands-on experience with clinical trial and pharmaceutical development preferred Basic understanding of CROs and scientific & nonclinical data/terminology, & the drug development process

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! **Remote Opportunity - open to candidates anywhere in the greater United States** **SUMMARY:** The Associate Director, Medical Affairs, Neurology serves as the internal scientific expert for assigned product(s), executing medical strategies and activities which align with cross-functional brand objectives, building and growing strong advocacy and KOL relationships and collaborating with other functions (e.g., Value Evidence, Regulatory, Clinical Development, Brand Teams, Global Medical Affairs etc.) in order to reach shared objectives and goals. This role emphasizes evidence generation and pipeline support in collaboration with our global organization, including Global Medical Affairs, Clinical Development, and Value Evidence teams. The position builds and grows strong advocacy and KOL relationships and contributes to strategic initiatives. **ESSENTIAL FUNCTIONS:** + Drives medical strategy in collaboration with Medical Director(s) and leads development, implementation and execution of key medical initiatives that align with the tactics of the Brand Team(s). + Develops and maintains expertise in designated therapeutic area(s). + Crafts and executes publication strategy and planning, including development and review of abstracts, posters, manuscripts for publication and scientific symposia presentations. + Provides therapeutic area expertise, review and evaluation of proposals for external clinical research. + Provides scientific training and/or support to other staff internally across functions as needed. + Develops, coaches and mentors' others within R&D, as requested. + Drives insight generation and distillation via 1:1 KOL engagements as well as formalized advisory board planning and execution + Lead US medical input into globally driven evidence generation initiatives including late stage and pipeline products + Collaborate with global Medical Affairs and cross-functional teams (Regulatory, Clinical Development, Commercial) to ensure strategic alignment and execution. + Liaises and manages relationships with Key Opinion Leaders (KOLs) in conjunction with the Medical Director(s), Medical Science Liaisons and other internal staff (e.g., Commercial, Clinical Development, Regulatory, etc.); and performs outreach activities in the field by working with other investigators, practicing physicians, patient organizations, and other health care providers. + Provides scientific input into Promotional Advertising Review Committee (and other review committees) for all promotional and external materials, participates in labeling meetings, where appropriate, and facilitates Sr. Medical Directors sign-off authorization. + Ensures all activities are following ICH, and other international regulatory guidelines and relevant GCPs and SOPs. + Participates in budgetary processes as part of annual business planning and review of expenses within Medical Affairs. **REQUIRED EDUCATION, EXPERIENCE and SKILLS:** + Accredited advanced clinical or scientific degree (i.e MD, PharmD, PhD, PA/NP or equivalent) + 3+ years of relevant medical/scientific affairs experience within the pharmaceutical or biotech industry. + Strong experience of collaborating with cross-functional teams, global medical affairs, medical information, value evidence and commercial teams. + Analytical skills - ability to combine practical, clinical knowledge with analytics/statistics to provide guidance on the design and execution of clinical studies. + Strong communication skills - ability to educate and train clinicians and other stakeholders. + Strong influence management skills - able to present compelling messages to influence key stakeholders. + Strong interpersonal skills - credible professional who can effectively communicate with a wide array of individuals, including stakeholders from other regions and cultures. + Experience with medical affairs content development. Familiarity with OPDP, PhRMA code, and key regulations in the pharmaceutical industry. **PREFERRED EDUCATION, EXPERIENCE AND SKILLS:** + Strong preference to be based in Deerfield, IL office. + 3+ years of relevant medical/scientific affairs experience within the pharmaceutical or biotech industry inclusive of setting and/or implementing medical strategy. + Thorough knowledge of migraine/headache therapeutic area strongly preferred including current scientific basics, treatments, and thought leaders. + Professional society membership(s) relevant to migraine/headache. + Regulatory knowledge and exposure, including experience with international regulations relating to GCP, conduct of clinical trials overseas. **TRAVEL** + Willingness/Ability to travel up to 10-20% domestically. International travel may be required. + If based remotely, additional travel will be required to Deerfield, IL, to meet the needs of the role and the business The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $190,000 - $220,000 and eligibility for a 20% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our career site (***************************************************************************************************************** . Applications accepted on an ongoing basis. \#LI-LM1, #LI-Remote **Why Lundbeck** Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on theU.S. career site (***************************************************************************************************************** . _Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit theU.S. career site (*********************************************************************** ._ _Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates inE-Verify (****************************************************************************************************************************** ._ **About Lundbeck** At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us. Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. The brain health challenge is real. Our commitment is real. Our impact is real. **About Lundbeck** At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us. Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. The brain health challenge is real. Our commitment is real. Our impact is real.

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. **Responsibilities** The **Field Specialist, Clinical Research** position that provides case support to physicians within a given territory. Case support provided on peripheral and coronary interventional procedures in pre-market and post-market phases of product development with SELUTION-SLR. The CFS plays a critical role in clinical studies including device training, case support and ensuring timely data collection for clinical programs. **Job Functions:** + Perform Physician and hospital staff training and procedural case coverage to ensure safe and effective use of the device + Present clinical study training materials based on investigational plans including study protocol, IFU, core lab manuals and case report forms + Provide field support for clinical studies by participating in site selection, site initiation and activation, supporting cases, ensuring quality data acquisition throughout follow up and performing study closure activities + Address clinical research site needs by maintaining frequent contact via email/phone/on-site visits with PI's and research coordinators + Responsible for gaining and maintaining knowledge of clinical sites in a given geographical area to best understand and assess investigators interests and capabilities + Manage key study sites (investigators and research staff) and serve as 'live' point of contact with the site for communication with SELUTION CSM, CRA, and CRO team + Partner with SELUTION clinical research teammates to meet business needs in the field including site CIP questions, re-training, case coverage, data entry/query resolution and escalation of critical issues + Administrative activities including evaluating metrics, data entry into trackers, documentation of activities and site feedback to SELUTION study teams + Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines and policies + Identify and mitigate quality risks and issues for assigned clinical studies with oversight from study management team + Assist with oversight of activities performed by CRO + Maintain in-depth knowledge of current study protocols, process and procedures to assist sites and facilitate study management team efforts **Role Expectations:** + Ability to travel **75%+** within designated geographic territory to facilitate on-site visits to assigned clinical sites + Be available to cross-cover sites as back up for other CFS territories, including holding necessary credentialing + Attend and lead SIV and site activation activities at assigned sites (in-person priority) for duration of the event + Attend start-up phase enrollments and clinical follow up visits at each assigned site to ensure site protocol compliance, image upload and readability and quality data collection Prioritize regular communication with study management team and CRO **Qualifications** Qualifications + Ability to travel **75%+** within designated geographic territory + Bachelor's Degree in life sciences, nursing, engineering, or healthcare related field (preferred) + Minimum 3 years' experience with cardiovascular procedures in clinical research in this same role or as a nurse or tech as radiology tech or Cath lab tech + Minimum 3 years' experience working directly with physicians and healthcare professionals + Prior experience with clinical trials (preferred) + Experience in coronary or peripheral interventions + Ability to travel (at least 75%) to company and clinical trial sites Pay / Compensation The expected pre-tax pay rate for this position is $76,450 - $125,000 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location. US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa. **Preferred Qualifications** Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one-s identity. All our teammate-s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming. **JOIN OUR TALENT COMMUNITY** Joining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you! Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests. **Job Locations** _US-CA-Irvine_ **ID** _2025-12332_ **Category** _Clinical_ **Position Type** _Regular Full-Time_ CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact *******************

Cresco Labs is one of the largest public, vertically integrated, multistate operators in the cannabis industry. Our portfolio of in-house cultivated and manufactured brands features some of the highest quality, most awarded and most popular cannabis products in America. With dozens of locations nationwide, our owned and operated Sunnyside dispensaries provide a welcoming, positive, judgement-free place to shop for anyone at any point on their cannabis journey. Founded in 2013, Cresco Labs' mission is to normalize and professionalize cannabis through our passionate employees. As stewards of the cannabis industry, our teams are constantly focused on supporting the needs of our fellow colleagues, consumers, customers, and communities alike. With a focus on Social Equity and Educational Development, our SEEDTM initiative ensures that our company reflects the communities in which we serve, ensuring equal opportunity for all to have the knowledge and resources to work in and own businesses in cannabis. At Cresco Labs, we aim to revolutionize and lead the nation's cannabis industry with a focus on quality and consistency of product, and to bring legitimacy to the industry with the highest level of integrity and professionalism. If you're interested in joining our mission, click the below links to join our team today! MISSION STATEMENT At Cresco, we aim to lead the nation's cannabis industry with a focus on regulatory compliance, product consistency, and customer satisfaction. Our operations bring legitimacy to the cannabis industry by acting with the highest level of integrity, strictly adhering to regulations, and promoting the clinical efficacy of cannabis. As Cresco grows, we will operate with the same level of professionalism and precision in each new market we move in to. JOB SUMMARY Cresco Labs is seeking an Accounts Receivable Coordinator to join our Finance team in Chicago, IL. This position will report to the Manager, Accounts Receivable and will be cross trained in the following four areas: Scanning checks, Cash Application & Collections. Cash application responsibilities: Recording and ensuring the timely posting of all cash received in Chicago, IL and all Wires/ACH payments received in our bank accounts. Collection responsibilities: ensuring that customer orders placed on credit or collection hold are quickly resolved. This includes ensuring licenses and tax certificates are current and legitimate. In addition, working with the Customer & Sales team to resolve past due balances. The ideal candidate is a self-starter who has AR experience, is highly organized, takes initiative, is detailed-oriented, and has strong problem-solving and analytical skills. This person must be able to work efficiently and easily adapt to changing priorities. This is a hybrid role, with a requirement to be in person at the Corporate office 50% and may work remotely 50%. CORE JOB DUTIES Cash Application: Customer checks; scan or mail to bank. Properly apply payments to the invoices on the customer remittance. Work with Accounting team on unapplied cash and NSF/Rejected checks. Review all banks several times per day for any new ACH or Wire payments. Collections: Contacting customers with past due balances by email or phone. Working with internal Sales team when needed. Update notes daily on the collection spreadsheet and save to shared drive. Recommend customer accounts for 10 Day Demand Letter or Bad Debt write-off. **The above is not all inclusive, this person will be responsible for other job duties as needed, including but not limited to timely responses to all audit requests. REQUIRED EXPERIENCE, EDUCATION AND SKILLS Associate or bachelor's degree in accounting, finance, or business preferred but not required. 5+ years of AR experience required with high volume of cash. Experience with financial accounting and ERP systems required (SAP and/or Sage Intacct preferred). Proficient in MS Excel (VLOOKUP's, pivot tables) and MS Office. Must possess strong organizational skills and be highly detail oriented. Must be able to take initiative. Strong problem solver. Strong and clear written and verbal communication skills required. BENEFITS Cresco Labs is proud to offer eligible employees a robust offering of benefits including, major medical, dental and vision insurance, a 401(K)-match program, FSA/HSA programs, LTD/STD options, life insurance and AD&D. We also offer eligible employees paid holidays and paid time off. Other rewards may include annual discretionary bonuses, stock options as well as participation in our employee discount program. Benefits eligibility for permanent positions may vary by full-time or part-time roles, location, or position. In accordance with any local and state compensation laws, the compensation listed is the current estimated range for the position. Final offer details and future compensation may be determined by multiple factors including but not limited to, geographic location, market compensation data, skills, experience, and other relevant factors. For questions about this please discuss with your recruiter during the interview process. Pay Range $25 - $27 USD ADDITIONAL REQUIREMENTS Must be 21 years of age or older to apply Must comply with all legal or company regulations for working in the industry Cresco Labs is an Equal Opportunity Employer and all applicants will be considered without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. California Consumer Privacy Act (“CCPA”) Notice to Applicants: Please read the California Employee Privacy Notice (“CA Privacy Notice”) regarding Sunnyside* and its affiliate Cresco Labs' policies pertaining to the collection, use, and disclosure of personal information. This CA Privacy Notice supplements the information contained in the Sunnyside* Privacy Policy and applies to California resident employees and job applicants. Applicants with disabilities may access this notice in an alternative format by contacting ************************* Reporting a Scam: Cresco Labs is aware of fictitious employment offers being circulated from various sources. Many of these schemes consist of an alleged offer of employment with Cresco Labs with the intention of gaining personal information, including payment and/or banking information. Be aware that fraudulent job offers and correspondence may appear legitimate: they may feature a Cresco Labs logo, they may appear to originate from an official-looking email address or web site, or they may be sent by individuals purporting to represent Cresco Labs or an entity which includes the word Cresco Labs in its name. Please note that Cresco Labs does not ask for payment or personal banking information as a condition of employment. Any personal information is requested for payroll or state badging purposes only. Applications can be securely submitted through our career's pages. We are working diligently to block this from happening. Beware if an offer of employment looks too good to be true. Never divulge personal and banking information or send money if you are unsure of the authenticity of an email or other communication in the name of Cresco Labs. If you are in doubt, please contact us at **************************** with questions.

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology, Inflammation or CMR preferred** The Study Physician (SP) is a critical global role that is created to fulfill aspirations of the client Medicine Excellence to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. SP work towards transforming client into a highly competitive performance organization by living target behaviors and AAI principles. **Accountabilities** + Responsibility for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with CTL, CPL, Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Timely preparation of high medical quality CTP, which supports to avoid CTP amendments. + Strong contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Timely provision of medically relevant critical data/process, related risks, and its mitigation/ monitoring strategies to the trial team. + Medical responsibility as co-author for development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsibility for providing medical input into definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + High quality and timely medical contribution to trial CQMP (and its amendments). + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Take medical responsibility for agile & adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data Ongoing medical review with transparent documentation of the activity, related findings, and its resolution. + Timely and ongoing monitoring of medical data to avoid the need for late-stage reviews and queries and ensure the adherence to trial timelines medical oversight by using advanced technologies and systems. Proactively address/ communicate clinical quality issues in a collaborative environment. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan , laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts etc.. + Responsibility for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, Trial Statistical Analysis Plan (TSAP) etc... Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report. + Timely contribution to the core study documents. Availability of high-quality study documents from medical perspective + Contribution to the medical content of responses to questions from regulators and Ethic Committees/IRBs. Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Response to medical queries from Investigators, CROs and/or Sponsor team representatives and contribution to maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. Support of Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM perspective. + Medical questions are responded in a timely manner and with state-of-the-art medical expertise. Delivery of high-quality data from medical perspective **Minimum Education/Degree Requirements** + Physician (MD) (ideally with medical thesis), trained in a clinical setting, and minimum of 4 years of active clinical practice experience; specialization in internal medicine or general practice is desirable. **Required Capabilities (Skills, Experience, Competencies)** + Excellent communication skills and team spirit. + Pronounced analytical skills and systematic and well-structured working style. Pronounced presentation and training skills. + Capability to work proactively and with team spirit in an international environment and team. + Displays the ability to use digital technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn & apply in a digital environment. + Excellent interpersonal, active listening, influencing skills and fluency in English, both written and spoken \#LI-LG4 \#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.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** The Medical Affairs Global Strategic Brand Lead (MA GSBL) is a core member of the Asset Maximization Team & co-leads the Global Co-creation Team (GCT). In collaboration with the Commercial Global Brand Lead (GBL) and Development Asset Lead (AL), the MA GSBL is responsible for driving the global value of a brand. This role focuses on long-term asset value creation, portfolio strategy, and lifecycle management to achieve the brand's full potential. The MA GSBL provides medical input into development of the brand strategy, leads the Core Medical Team (CMT) and facilitates agile Core Medical Plan (CMP) development whilst remaining accountable for delivery of CMP evidence generation and dissemination tactics. The MA GSBL ensures seamless execution of CMP that balances global objectives with local needs and adaptability. As Benefit Risk Team (BRT) chair, the MA GSBL is also responsible for leading, presenting and defending routine and ad-hoc assessments concerning the Benefit/Risk of the product. **Essential Job Responsibilities:** **Strategic Leadership:** + Lead co-creation of the Integrated Global Brand Plan (iGBP) with cross-functional experts and co-creation affiliates, serving as the brand's strategic foundation + Lead the development of Medical Product Strategy (MPS) and facilitate agile Core Medical Plan (CMP) Development + Contribute to creation of Integrated Evidence Generation Plan (iEGP) with cross-functional experts, serving as the strategic foundation for evidence generation + Define and oversee overarching brand objectives with medical KPIs, ensuring alignment with global and local strategies + Co-lead the development of Global Launch Plans. Present to executive leadership at Global Launch Readiness Review meetings, optimizing readiness for an exceptional launch + Lead Medical input for Lifecycle Management (LCM) strategies and Loss of Exclusivity (LOE) planning to + enhance long-term asset value **Medical Affairs Excellence:** + Lead a high-impact CMT with accountability for delivery of CMP evidence generation and dissemination tactics, ensuring seamless execution that balances global objectives with local needs and adaptability. + Accountable for budget management associated with evidence generation and dissemination tactics executed globally + Empower & enable affiliates to deliver on non-evidence generation and dissemination tactics of the CMP, whilst encouraging iterative dialogue to address local needs + Overall accountable for all MA evidence generation activities supporting the brand strategy. Activities may be executed by global, regional, or local teams. Lead CMT Study Review Committee (CMT SRC) to ensure robust governance and review of synopsis/protocols of all MA sponsored studies maintaining high standards for evidence generation + Accountable for implementation of the Integrated Evidence Dissemination Plan with strong scientific messages to support the brand. Ensure provision of centralized resources and iterative feedback to refine scientific messaging + Enable execution of the medical components of the Global launch plan, providing KPIs and metrics to track global progress + Responsible for leading, presenting and defending routine and ad-hoc assessments of the Benefit/Risk of the assigned product. Represent BRT perspective at Global Benefit Risk Committee (GBRC) and in communication with Executive Labelling Committee (ELC) **Cross-Functional Collaboration:** + Foster cross-functional collaboration (e.g., AMT, GCT, BRT) through Agile touchpoints + Collaborate with Commercial, Market Access, Development, Patient Centricity, Local (co-creation) and Regional Medical Affairs Teams to align on strategies that reflect the needs of patients and healthcare providers + Partner with R&D teams to influence asset development and ensure clinical viability and patient access for future pipeline assets + Communicate key insights captured through advisory interactions and Field Medical with the Asset Team and GCT, ensuring swift responses to evolving needs. Support identification of KEEs and academic institutions to drive accelerated clinical trial delivery in line with Bold Ambition + Drive integration and alignment across geographies, ensuring a consistent approach to medical affairs execution and messaging for the brand + Collaborate with key stakeholders (e.g. Regulatory Affairs, Labelling, Pharmacovigilance, Commercial) to create competitive and optimized product labels aligned with regulatory requirements and market needs **Stakeholder Engagement:** + Build and maintain strong relationships with external stakeholders, including diagnostic partners, testing labs, key external experts, advocacy groups, medical organizations and regulatory bodies, to strengthen the company's global presence and reputation in PM + Act as a trusted representative for the company in external forums, conferences, and industry partnerships **Coaching and Team Development:** + Coach and develop members of the team, fostering competencies and behaviors aligned with the Astellas way, CMT Ways of Working and preparing for future organizational needs + Drive cultural and operational transformation initiatives, ensuring long-term sustainable success **Compliance and Ethics:** + Embed a strong compliance culture across all activities, ensuring adherence to company policies and industry regulations + Act as a role model for ethical behavior, fostering integrity and accountability within the organization **Qualifications Required:** **Education:** + A medical degree (MD or equivalent) or Doctorate degree in Pharmacy or Pharmacology recognized by one of the leading governing bodies from around the globe **Experience and Expertise:** + Minimum 10+ years of progressive leadership experience in country, region or global Medical Affairs, Medical Safety or Clinical Development roles within the Pharmaceutical or biotechnology industry, with a significant amount of time spent in Medical Affairs + Expertise in leading cross-functional and geographically diverse matrix teams while delivering high-impact business results. The ability to influence without direct authority is a critical skill set for this role. + Demonstrated success in leading the brand medical affairs strategy, including product launches and lifecycle management + Strong ability to develop innovative, patient-centered medical affairs evidence generation and dissemination strategies that drive patient access and brand performance + Has knowledge of TA/disease/product and is able to operate across multiple products within TA. + Has advanced understanding of rules and regulations in pharma, including knowledge of global regulatory bodies and procedures, as well as anti-kickback laws, which could have impact for the pharmaceutical industry. Appropriate knowledge of guidelines and regulations such as IFPMA (International Federation of Pharmaceutical Manufacturers Association), PhRMA (Pharmaceutical Research and Manufacturers of America), FDA, EMA, PMDA, ACCME and OIG. Is able to apply legal and compliance knowledge to Medical Affairs activities + Experience in managing large budgets with demonstrated ability to apply proactive risk management on budget and timeline **Skills and Leadership:** + Proven ability to lead and inspire high-performing global matrix teams in a fast-paced, matrixed environment + Exceptional strategic thinking, business acumen, and decision-making skills + Strong communication, influencing, and stakeholder management abilities + Complex problem-solving skills and ability to manage more complex problems within a brand team **Preferred:** + Medically qualified with at least 5 years of direct patient care + Medical specialty and/or experience in relevant therapeutic area. + Work experience across multiple cultures and countries / regions. **Working Environment:** + This position is globally based with location flexibility and will require some on-site work. + At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. **Salary Range** : $280,000-$440,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** : + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company-paid fleet vehicle for eligible positions + Referral bonus program \#LI-CH1 Category MA Global Brand Strategy Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

We are looking for an experienced personal trainer who is passionate about motivating others through fitness! You will be working directly with clients to help them achieve their fitness goals through encouragement, education, and a customized training plan. You are passionate about health and fitness and love to empower others to achieve their goals. You are self-motivated, a natural teacher, and actively look to help people. Responsibilities: Teach fitness techniques to personal training clients Develop individualized training programs Evaluate individual capabilities and training needs Demonstrate activity techniques and proper equipment use Enforce facility rules and regulations Qualifications: Personal training or group training certification (required) CPR and First Aid certifications (required) 2+ years of personal training or group fitness instruction Able to perform exercises and movements as demonstrations to clients Strong interpersonal and communication skills Complete our short application today! This is a remote position. Compensación: $20.00 - $50.00 per hour Who We Are: Victory Hearing & Wellness (VHAW) At Victory Hearing & Wellness (VHW), we believe in a integrative approach to health and wellness. As a leading provider of audiological and wellness services in the Austin Metro area, we are dedicated to transforming lives by enhancing hearing health and overall well-being. With two conveniently located clinics in West Lake Hills and Hutto, Texas, VHW combines cutting-edge technology, compassionate care, and evidence-based practices to deliver exceptional results for our patients and clients. Our Mission: To empower individuals to achieve optimal hearing health and total wellness by addressing their unique needs through comprehensive care, education, and personalized solutions. Our Vision: To redefine healthcare by offering integrative services that merge audiological expertise with wellness strategies, creating a 360-degree approach to improving quality of life. Our Story: Victory Hearing & Wellness was born from the integration of Victory Hearing & Balance, a trusted audiological clinic, and Victory Health & Wellness, a dynamic wellness brand formerly known as Star Ranch Fitness. Together, we've created an innovative health ecosystem that provides exceptional care across hearing health, nutrition, exercise therapy, cognitive training, and lifestyle coaching. Led by Dr. Jill Davis, Au.D., Director of Clinical Operations, and Victor Davis, Certified Health Coach, our expert team collaborates to address the six dimensions of wellness: physical health, nutrition, medical care, sleep, mental fitness, and social interaction. What We Offer: Hearing Health Services: Comprehensive audiological care, including hearing aids, balance testing, tinnitus management, and preventive education. Integrative Wellness Programs: Diagnostic labs, exercise therapy, personal training, nutrition coaching, and supplement protocols tailored to individual needs. Comorbidity Screening and Prevention: Risk assessments and evidence-based interventions for conditions like diabetes, cognitive decline, and hearing-related comorbidities. Innovative Patient Care: Advanced tools like music training for cognitive health, fall prevention protocols, and virtual support via our VHW Coaching App. Why Join Us? At VHW, we are more than just a clinic-we are a community of professionals who are passionate about making a meaningful difference in the lives of those we serve. By joining our team, you'll be part of an organization that values growth, innovation, and collaboration. Whether you're an audiologist, health coach, exercise therapist, personal trainer or wellness specialist, you'll have access to state-of-the-art facilities, ongoing education, and the opportunity to work within a supportive and dynamic environment. Our Core Values: Excellence: Pursuing the highest standards in patient care and wellness services. Integrity: Building trust through honest, ethical practices. Innovation: Embracing new technologies and methods to improve outcomes. Community: Fostering meaningful connections among patients, clients, and professionals. Our Culture: Be the go-to health and wellness provider for clients and patients nationwide by making living a healthy lifestyle easy for them ~ Be considerate of each other Be honest, accountable, and trustworthy Respect each other's time and opinion Do what is right ~ Be considerate of clients We succeed when our clients succeed Go above and beyond the expectation Actively listen and be empathetic ~ Be considerate of the industry Foster win-win, long-term relationships. Be fair Respect what our team members and clients bring to the table Value the industry and contribute to it Join us at Victory Hearing & Wellness and be part of a movement that's redefining integrative healthcare. Together, we'll help individuals thrive at every stage of life. This franchise is independently owned and operated by a franchisee. Your application will go directly to the franchisee, and all hiring decisions will be made by the management of this franchisee. All inquiries about employment at this franchisee should be made directly to the franchise location, and not to ISSA Online Corporate.

About Us: Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs. Ranked #2 in 2024 on Crain's Fast 50 in Chicago, and in the top 100 of Crain's Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for - working together toward a common goal, for the greater good. Position Summary: The Associate Director, Sales Operations is responsible for leading and optimizing the sales operations function to drive efficiency, effectiveness, and productivity within the commercial sales, marketing, and virtual sales teams. This role involves strategic planning, process improvement, data analysis, a focus on optimization, and cross-functional collaboration to support the achievement of sales targets and business growth. The compensation range for this position is $140,000 - $180,000. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. Why Work with Us? Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week. Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style. Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas. Professional Growth: We offer ample opportunities for professional development and career advancement. Essential Duties and Responsibilities include the following. Other duties may be assigned. Strategic Planning and Execution: Develop and implement sales operations strategies (e.g., sample management, sales territory design, sales incentive design and implementation, commercial workforce optimization) that align with overall business objectives. In collaboration with senior leadership, define and implement operational projects which help achieve sales goals and deliver revenue. Sales Process Optimization: Analyze and refine sales processes to improve efficiency and effectiveness. Implement best practices and tools to streamline sales activities and enhance productivity. Define and improve sales force effectiveness metrics. Assess and develop sales operations training, as required. Sales Incentive Compensation Leadership Lead the development, administration, budgeting, and effectiveness of sales incentive compensation plans. Carefully develop and manage sales incentive compensation budgets in partnership with commercial finance. Lead the development and communication of sales incentive compensation. Develop and implement incentive compensation governance programs. Sales Data Analysis and Reporting: Oversee the collection, analysis, and reporting of sales data to provide insights and recommendations. Work cross-functionally to develop and maintain dashboards and reports to track key performance indicators (KPIs) and sales metrics. Cross-Functional Collaboration: Work closely with marketing, finance, product, and customer success teams to ensure alignment and support for sales initiatives. Facilitate communication and collaboration between sales and other departments. Technology and Tools Management: Evaluate, implement, and manage sales technology and tools, such as CRM systems (Veeva), reporting systems, and related data structures to support sales operations. Ensure the effective use of technology to enhance sales processes and data management. Budget Management: Develop and manage the sales operations budget, ensuring efficient allocation of resources. Monitor expenses and optimize costs to achieve financial targets. Contract compliance: Develops and manages enhanced Tableau-based contract compliance tools; provides monthly reports and presents updates to senior leadership on GPO, IDN, Wholesaler and other key contract performance metrics. Competencies Business Acumen Judgement Change Management Project Management Ethics Interpersonal Qualifications Bachelor's degree in business administration, Sales, Marketing, or a related field; MBA preferred. 7+ years of experience in pharmaceutical sales operations, with at least 3 years in a leadership role. Strong analytical and problem-solving skills, with the ability to interpret complex data and make data-driven decisions. Excellent communication and interpersonal skills, with the ability to influence and collaborate with stakeholders at all levels. Proficiency in sales technology and tools, such as CRM systems (e.g., Salesforce, PowerBI, Varicent, etc.). Proven track record of driving sales process improvements and achieving sales targets. Strong leadership and team management skills. Travel Up to 25% occasional travel may be required. Equal Opportunity Employer: Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities. Salary Description $140,000 to $180,000

**Associate Director - Padcev Marketing** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose:** Astellas is looking for a Strategist (External Title: Associate Director), Key Customer Marketing for PADCEV (enfortumab vedotin), a breakthrough therapy for patients with locally advanced/metastatic urothelial cancer. The successful candidate will be a core member of the U.S. brand team and will contribute to the development and implementation of insight gathering initiatives to help maximize brand potential. This person is responsible for strategy and tactical plan development/execution pertaining to: Key External Expert Engagement; Insights gathering, Peer-to-peer programs; and Advisory boards working in close collaboration with internal and external partners, including co-promote partner Pfizer, Sales/Medical Affairs/Marketing teams, Third party vendors, KEEs, and Agency partners. Specific responsibilities will evolve based on the needs of the brand, LCM plans and competencies required on specific projects. **Essential Job Responsibilities:** _Key External Expert Engagement:_ 1) Identify and develop trusted relationships with National, Regional and Local Key External Experts (KEEs) in urothelial cancer, particularly Oncologists and Urologists. 2) Monitor KEE opinions about evolving urothelial cancer disease management, synthesize key insights and translate into implications for PADCEV. 3) Obtain KEE engagement insights that can inform promotional strategies and tactics. 4) Manage opportunities and challenges pertaining to KEE engagement experiences. 5) Develop custom engagement plans for aligned national/regional KEEs - ensure strong coordination with co-promote partner and functional partners (i.e. Sales, Key Account Teams, etc.) 6) Ensure integration of KEE insights into Brand and functional action plans to achieve business objectives and goals. _Peer-to-Peer Programs:_ 1) Lead the strategy and development of commercial Advisory Boards and Webinars in partnership with Pfizer as well as other KEE engagement programs. 2) Synthesize and share KEE insights with functional partners to inform brand strategy and tactical plans. 3) Develop with our co-promote partner Pfizer and external agencies, all content to be used as part of our promotional Speaker Bureau. 4) Partner with the PADCEV KEE Manager to identify, coach, and train promotional speakers on program content. 5) Advise and guide the PADCEV KEE Manager on their responsibilities in managing speaker bureau execution. 6) Identify and plan additional peer-to-peer programs in approved indications. Lead the development and review of related content for approval. _Other:_ 1) Manage external agencies including project management (incl. timelines, project estimates, budget tracking, and execution) consistent with Astellas' goals and ethics & compliance guidelines. 2) Implement other initiatives as assigned. **Organizational Context:** This position presents a significant opportunity to assess, recommend, and lead activities that will directly influence the short and long-term strategies and success of PADCEV. This position requires: a proven and high proficiency level of collaboration across numerous functions and external stakeholders; strong strategic planning and tactical execution; a highly motivated self-starter with exceptional communication and relationship building skills. This position does not have direct reports. **Qualifications Required:** + Significant experience engaging with Key External Experts in the field of Oncology. + High degree of clinical acumen, preferably in urothelial cancer. + High level of Professional Maturity; Emotional Intelligence; Proactive Leadership; and experience engaging/interacting with influential customers and senior level management. + Bachelor's degree. + 10+ years of related, relevant experience in pharma (marketing, sales, sales training, etc.). + Proven analytical and critical thinking skills to diagnosis business challenges and recommend solutions for brand strategic/tactical plan inclusion. + Deep oncology therapeutic knowledge and experience. + Demonstrated ability to build strong relationships with KEEs. + Excellent communication and interpersonal skills. + Strong project management experience with the ability to manage simultaneous initiatives. + Demonstrated ability to influence peers and internal/external stakeholders. + New brand or indication launch experience. + Ability to travel 50% or more if needed. **Preferred:** + MBA or other related graduate level degree. + Existing KEE relationships in urothelial cancer. + Recent experience in launching a new drug and/or indication. + Experience working in a partnership / co-promotion. Flexible grade level based on candidate background and skillset. **Salary Range** **:** $141,400 - 222,200 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** **:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-TD Category PADCEV Brand Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Remote work within the continental US may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote or hybrid work are encouraged to apply. Purpose: The XTANDI Commercial Brand Strategy Lead is responsible for leading and driving the development and implementation of the XTANDI US Strategy and connection to tactical execution through leadership and close collaboration with the rest of the Brand Team. They will be responsible for the leading the Brand Planning process, Competitive Readiness and Life Cycle Management plans, working closely with key functional partners and the Commercial Head to understand key brand insights and performance factors, helping to mobilizing the team to address those insights, and other critical strategic projects Additionally, this colleague will be a key member of internal global and alliance teams. The Commercial Lead reports directly to the XTANDI Commercial Head and sits on the US XTANDI Marketing Leadership team and will be a critical role in driving the success of the business. This colleague is responsible for ensuring and modelling strong cross-functional alignment in the Brands@Center Operating Model and ensuring execution of strategy with key partners, especially other members of the brand team, alliance partner, Market Access, Global Marketing, CI, Sales, Training, Regulatory, Legal, Medical Affairs, and agencies. Specific responsibilities will evolve based on the needs and lifecycle of the brand, and competencies required on specific projects. Essential Job Responsibilities: Leading the development of the US Strategic Plan and Tactical Plan and approved budget across the XTANDI alliance and in alignment with global colleagues Leading the Life Cycle Management plan for XTANDI across cross functional and alliance partners and ensuring strong alignment and execution Development and implementation of competitive readiness plans In collaboration with Commercial Insights Lead, to lead the team in actioning against key insights and market events Lead development and completion of executive reporting (QBR, MBR, IR) and forecasting with Commercial Head and other cross functional partners Together with the Commercial Head, this role will be a key day-to-day contact for brand leadership with our alliance partner: member of XTANDI Joint Commercialization Committee. As key member of XTANDI Marketing Leadership Team, lead and implement other initiatives to support team and overall brand and/or enterprise as assigned Ensure all work is completed in an ethical and compliant manner Quantitative Dimensions Financial and brand performance Marketing strategy, management, and execution Customer satisfaction and experience - enabling strong, business-centric, collaborative relationships with customers, both internal and external Driving business performance through effective cross-functional team dynamics and collaborative initiatives Contributes with an enterprise mindset by leveraging and sharing best practices across the organization Efficient use of resources including management of vendors, negotiation for services both internally and externally, and monitoring of budgets Organizational Context This individual will report to the US Commercial Head, XTANDI. This position will need to fully develop working relationships with external partners and internal colleagues from other departments (including global, medical affairs, market research, legal, and regulatory) as well as multiple functions within the alliance partner. Frequent contact and collaboration with Commercial Heads and/or associated senior level colleagues across functions is expected. This role requires high levels of collaboration for success and will need to be consistently demonstrated through the sharing of ideas that leads to creative solutions.

Job DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit ******************* or follow MMS on LinkedIn. This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities: Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator's Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs) Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports) Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC Demonstrated ability to lead others to complete complex projects Ability to complete documents according to sponsor's format, processes, and according to regulatory guidelines Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment Organizational expert within the nonclinical subject area Excellent written/oral communication and strong time and project management skills Ability to attend regular team meetings, lead client meeting and CRMs Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP) Requirements: BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control Knowledge of GLP, ICH guidelines, and applicable regulatory requirements 2+ years of pharmaceutical regulatory nonclinical writing experience Strong writing and analytical skills Proficiency with MS Office applications. Hands-on experience with clinical trial and pharmaceutical development preferred Basic understanding of CROs and scientific & nonclinical data/terminology, & the drug development process Powered by JazzHR KWhojlTGLh

**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology, Inflammation or CMR preferred** The Study Physician (SP) is a critical global role that is created to fulfill aspirations of the client Medicine Excellence to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team. SP work towards transforming client into a highly competitive performance organization by living target behaviors and AAI principles. **Accountabilities** + Responsibility for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with CTL, CPL, Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates. + Timely preparation of high medical quality CTP, which supports to avoid CTP amendments. + Strong contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Timely provision of medically relevant critical data/process, related risks, and its mitigation/ monitoring strategies to the trial team. + Medical responsibility as co-author for development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsibility for providing medical input into definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + High quality and timely medical contribution to trial CQMP (and its amendments). + Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Take medical responsibility for agile & adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data Ongoing medical review with transparent documentation of the activity, related findings, and its resolution. + Timely and ongoing monitoring of medical data to avoid the need for late-stage reviews and queries and ensure the adherence to trial timelines medical oversight by using advanced technologies and systems. Proactively address/ communicate clinical quality issues in a collaborative environment. + Contribution to the timely preparation of medically relevant core trial documents and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan , laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts etc.. + Responsibility for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, Trial Statistical Analysis Plan (TSAP) etc... Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report. + Timely contribution to the core study documents. Availability of high-quality study documents from medical perspective + Contribution to the medical content of responses to questions from regulators and Ethic Committees/IRBs. Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Response to medical queries from Investigators, CROs and/or Sponsor team representatives and contribution to maintenance of trial FAQ log/list. + Building network with experts and active contribution to site engagement. Support of Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM perspective. + Medical questions are responded in a timely manner and with state-of-the-art medical expertise. Delivery of high-quality data from medical perspective **Minimum Education/Degree Requirements** + Physician (MD) (ideally with medical thesis), trained in a clinical setting, and minimum of 4 years of active clinical practice experience; specialization in internal medicine or general practice is desirable. **Required Capabilities (Skills, Experience, Competencies)** + Excellent communication skills and team spirit. + Pronounced analytical skills and systematic and well-structured working style. Pronounced presentation and training skills. + Capability to work proactively and with team spirit in an international environment and team. + Displays the ability to use digital technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn & apply in a digital environment. + Excellent interpersonal, active listening, influencing skills and fluency in English, both written and spoken \#LI-LG4 \#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.

Job Description Summary: The Director of eCommerce will drive the growth of our North American DTC channel, leading strategy and execution across our brand websites. This role will be responsible for delivering exceptional user experiences, increasing conversion, optimizing the customer journey, and hitting ambitious revenue targets. The Director - eCommerce will partner cross-functionally with Marketing, Creative, Operations, and Product Development teams to ensure a seamless brand presence online. Essential Duties and Responsibilities: eCommerce Operations Execute the North American eCommerce strategy aligned with broader business goals and digital objectives Manage the direct-to-consumer digital business, ensuring consistent growth in awareness, engagement, and revenue Lead initiatives that improve the customer journey from discovery through conversion and retention Oversee eCommerce merchandising strategy, promotions, seasonal campaigns, inventory planning, content and analytics Build strong partnerships with internal stakeholders (Finance, Marketing, Product Development, Supply Chain, Customer Service) to ensure North American business achieves its goals Manage third-party agencies, system integration partners and vendors (developers, subscription platforms, CRO tools, etc.) Digital Execution Manage and implement an ecommerce roadmap to drive revenue, profitability, and customer satisfaction Launch new capabilities with a focus on loyalty, personalization, and content Champion the customer experience by improving UX, streamlining journeys, and delivering personalized content Identify and integrate emerging digital capabilities to drive differentiation and engagement Data & Analytics Provide weekly and monthly sales reporting with defined KPIs Surface actionable insights using customer surveys and digital analytics Test and refine site experiences to improve conversion and retention rates Track the ROI of digital investments with clear reporting on customer growth, engagement, and eCommerce performance Performance & Optimization Use data and testing to identify friction points in the customer journey and prioritize improvements Collaborate with Finance to develop budget scenarios tied to sales goals and marketing investments Work closely with Planning teams to align inventory with demand, optimize assortments, and ensure product availability Provide regular reporting to senior leadership on DTC performance Qualifications: A Bachelor's degree is required, preferably in a Marketing, Communication or related field; advanced degree preferred. A minimum of 12 years of experience in eCommerce or digital marketing, preferably in beauty, skincare, or CPG is required, with a minimum of five years in a management role with DTC responsibility. Proven success scaling an eCommerce business and achieving revenue targets. Proficiency in Salesforce Commerce Cloud and analytics tools (Google Analytics, etc.). Experience with CRM/email marketing (Klaviyo), conversion rate optimization (CRO), and A/B testing platforms. Strong understanding of digital advertising, SEO, and retention strategies. Exceptional project management and communication skills. Passion for skincare and understanding of the beauty consumer a plus. Additional skills and abilities include: Adaptive, responsive individual able to thrive in an extremely fast-paced and dynamic work environment; handles pressures well; adjusts plans to meet changing needs. A team player who works well with a variety of field-based sales groups, cross-functional teams, brand leadership, global and clinical/retail partners. Excellent organizational, time and project management skills. Stay updated with market trends and competitor activities. Excellent communication and negotiation abilities. Problem-solving and decision-making capabilities. Work Environment: The work is typically indoors in an office environment with occasional visits to field or customer locations for market research. Work Hours: The work schedule is 5 days per week, 8 hours per day. Initial start time may vary, with work hours typically from 8am-5pm. Work hours and shifts are subject to change depending on operating business conditions and needs. The position resides in Orange County but may be hybrid with 2 days being remote work. Physical and Mental Demands: Sedentary, exerting up to ten pounds of force occasionally, or negligible amounts of force frequently, to move objects. This job also requires constant sitting. Constant use of the upper extremities is required to reach, handle, and position tools and equipment. The employee must know and follow proper safety protocols and maintain a professional and polished appearance. The employee must also be able to maintain and preserve confidentiality of company information, exhibit strong interpersonal skills and the ability to build relationships with internal stakeholders including external partners to foster collaboration and implement consistent messaging company wide.