United Therapeutics Corporation

Oversee and coordinate local/regional clinical trials ensuring timelines, budgets, quality, and compliance with regulations while managing vendors and cross-functional teams. | Bachelor’s degree with 8+ years in clinical study or project management in CRO/pharma, strong GCP/ICH knowledge, clinical research background, and proficiency with MS Office and clinical systems. | California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You are The Clinical Project Manager II/Senior Clinical Project Manager will work independently to ensure the success of a local or regional clinical trial. This role provides oversight and coordination for the operational delivery of ongoing local/regional clinical trials to ensure all required timelines are met as well as adherence to budget, quality, and performance expectations. Utilize advanced expertise and serve as the primary study contact for study-related communication, coordinating with teams, management, and vendors Independently oversee the entire lifecycle of clinical trials, from start-up to close-out Direct local or regional clinical trials, ensuring cross-functional activities align with study objectives Administer study budgets and timelines, maintaining high-quality standards and performance metrics Identify, resolve or escalate any concerns regarding study timelines and deliverables promptly Proactively escalate performance related concerns with appropriate line management Manage protocol deviations/violations diligently, reducing their occurrence through proactive collaboration Collaborate with Clinical Operations to monitor key performance indicators, enhancing study efficiency Provide consistent updates on study progress to the project team and management Manage insourcing / outsourcing partners, ensuring compliance with standards and expectations Contribute to the development of study concepts, protocols, and critical study documents Engage in the creation of policies, guidelines, and SOPs, contributing to the advancement of Clinical Operations and Study Management Assess and enhance current processes, recommending improvements to management Ensure study conduct aligns with SOPs, ICH/GCP guidelines, and local regulations Manage vendor relationships, including selection, negotiation, implementation, Statement of Work (SOW) oversight Ensure comprehensive protocol and process training for all study team members Manage resources allocated to the study, excluding staff management Review and endorse team member transition plans as necessary Assist in the preparation of interim and primary analysis reports Organize and oversee Investigator Meetings, ensuring effective coordination Perform all other duties as required Minimum Requirements Education and Experience requirements for Clinical Project Manager II level: Bachelor’s degree in related field and 8+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development Master’s degree in related field and 6+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development Education and Experience requirements for Senior Clinical Project Manager level: Bachelor’s degree in related field and 10+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development Master’s degree in related field and 8+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development General therapeutic area education and training Ability to interact and communicate effectively, both verbally and in writing, within and outside clinical operations, with colleagues, upper management, Key Opinion Leaders, vendor personnel, and clinical investigators and site personnel Strong working knowledge of GCP/ICH regulations and guidelines Strong overall scientific and clinical/medical research background Experience and comfort in working both independently and as part of a cross-functional team Proficiency with MS Office Suite including Word, Excel, PowerPoint, and Outlook Experience with EDC and CTMS systems Commitment and ability to handle high workloads, demanding situations, and deadlines Ability to proactively identify potential issues and formulate potential course(s) of action Preferred Qualifications Master’s degree 3+ years of related experience as a CRA, Clinical Manager, and/or Project Manager in the biopharmaceutical industry highly preferred RN - Registered Nurse - State Licensure and/or Compact State Licensure Previous experience with all phases of clinical research Demonstrated leadership experience as evidenced by the ability to motivate teams, provide advanced planning analysis, provide strategic guidance by evaluating risks against departmental deliverables Job Location & Travel This position will be located at our Durham, NC office with a hybrid schedule of 4 days in office and the option to work 1 day each week from home. In office requirements could change based on business needs. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success. We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.

Provide HR administrative support including onboarding, termination processing, employee file management, and general HR department assistance to ensure efficient HR operations and excellent employee experience. | Requires a high school diploma or GED with 2+ years relevant administrative support experience, proficiency in Microsoft Office, excellent communication and organizational skills, and preferably experience with HRIS, ATS, SharePoint, and Smartsheet. | California, US residents click here. The job details are as follows: Who we are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension( PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who you are Are you looking to join an innovative biotech company whose mission is to help very sick patients through the development of novel therapeutics and progress toward an unlimited supply of transplantable organs? We are looking for an experienced HR Coordinator to support the HR Talent Management function, as well as HR department in various administrative tasks and to maintain efficient HR processes to provide the best employee experience possible. Support the successful onboarding process for new employees, including: Preparing and sending new hire welcome and manager congratulatory emails Printing, binding, packaging, and maintaining an ample supply of new hire welcome packets Mailing new hire packets following new hire welcome communication Following up with new hires to ensure completion of both pre- and post-hire tasks in HRIS Requesting badge creation Ensuring all new hires are sent new hire meeting invites for IT orientation, the Company & Benefits overview, and I-9 verification Providing support for the I-9 verification process and manage remote I-9 verification process (future state) Launching new hire goals task in HRIS and schedule all new hire check-ins with HRBPs Reviewing, revising, and maintaining the Employee and Manager Onboarding Guides, as needed Provide general administrative support to the Human Resources department, including ad hoc support to Benefits, HRBPs, Talent Development, HR Operations, and Compensation Provide top notch HR customer service to all employees by addressing routine employee inquiries and escalating questions appropriately to HR management, Talent Management/HRBP, Benefits, Talent Acquisition, L&D, HR Systems, or Compensation teams Provide administrative support throughout the termination process, including: Preparing and providing exit information packets Scheduling exit interviews with appropriate HRBP Sending termination certificates for signatures Uploading resignation letters and signed term certifications to HRIS Manage and support new vendor set up, contract requests, PO requests, and PO revisions requests Maintain employee files, including: reviewing, auditing, and uploading documents to HRIS Send reminders to managers regarding employee PTO usage, to include: timely approval of PTO, employees with negative PTO balances, and employees who have not utilized PTO in 6+ months Maintain and/or audit CCTs (childcare taxable fringe benefit) in HRIS to ensure timely and accurate entries in support of an error-free payroll process Manage business cards (all employees), including Contact information gathering, proof review, and reorders Maintain ample supply of letterhead for the HR team Support maintenance and auditing of all necessary employment posters and notifications in all buildings Contribute to maintaining and updating HR Talent Management SOPs on a bi-annual basis Coordinate any maintenance that is needed for kitchen, copy areas, and postage machine Draft employment verification or attestation letters, as needed Support and guide office-based employees to the appropriate HR and/or business colleague when inquiries arise Order supplies for HR team, as needed Minimum Requirements H.S. Diploma or General Education Degree (GED), with 2+ years of relevant administrative support experience Proficient in Microsoft Outlook, Word, Excel, PowerPoint, and OneNote with ability to read, analyze and interpret general information and data Excellent organizational, time management, oral and written communication skills Ability to interact with all levels of employees and management Preferred Qualifications Associate's or Bachelor’s Degree with 2+ years of relevant administrative support experience, including 1+ years of experience in a Human Resources administrative support role or related field Experience using ATS and HRIS systems, also SharePoint and Smartsheet Job Location This role is based in the United Therapeutics Silver Spring office 5 days per week. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. The salary for this position ranges from $30.05 to $32.69 per hour. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success. We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.

Research, write, and edit regulatory and scientific documents for clinical studies and product development, collaborating cross-functionally and managing document review cycles. | Bachelor’s degree in science with 5+ years medical writing experience, preferably with regulatory and global medical communications expertise, and strong interpersonal skills. | California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are You are creative and detail-oriented with deep expertise in regulatory submissions and writing, including clinical study reports, clinical study protocols, and investigator’s brochures. You also bring strong experience in external-facing scientific communications - such as manuscripts, posters, and abstracts – to deliver accurate and impactful scientific content. You thrive in a fast-paced, innovative company where collaboration and adaptability are crucial to success. The Senior/Medical Writer will support Global Medical Affairs Phase 3b/4 research as well as early phase product development. Work independently to research, write, and edit abstracts, manuscripts, posters, and several regulatory documents including but not limited to: clinical study protocols and reports, Investigator's Brochures, and safety documents that may be submitted to the Food and Drug Administration and other global health authorities for publication. Collaborate with clinicians, clinical scientists, and biostatisticians to interpret study results and post-hoc analyses to ensure study objectives, results, and statistical interpretations are accurately and clearly reflected in relevant documents. Serve as lead author for complex clinical and regulatory documents including clinical study protocols, IBs, ICFs, CSRs, clinical narratives, PBRER/DSURs, and regulatory submission modules (e.g., CTD sections). Provide strategic input into document planning and content development to ensure alignment with clinical and regulatory goals. Partner with Data Management, Biostatistics, Regulatory Affairs, Clinical Operations, Safety, and Medical Monitoring to synthesize data and insights for document development. Facilitate cross-functional review cycles and ensure timely delivery of high-quality documents. Collaborate with external HCPs, KOLs, CROs, and Global Medical Affairs scientific leads to author peer-reviewed manuscripts, scientific abstracts, posters, and presentations. Lead the development of scientific slide decks and educational materials for HCP engagement and congress presentations. Establish and maintain document tracking systems and contribute to continuous improvement of medical writing processes. Ensure consistency in scientific messaging and style across related documents and programs. Contribute to the creation, revision, and governance of clinical and medical writing SOPs. Ensure adherence to internal style guides, regulatory guidance documents, and industry best practices. Author technical reports, briefing documents, and other materials to support early-phase clinical development and regulatory interactions Provide guidance and mentorship to junior writers and review documents for scientific integrity, clarity, and consistency Support ad hoc writing needs and complex initiatives as required Minimum Requirements Medical Writer - Bachelor’s Degree in a science-related field with 5+ years of experience in medical writing Senior Medical Writer - Bachelor’s Degree in a science-related field with 5+ years of experience in medical writing Excellent interpersonal skills Attention to detail Preferred Qualifications Master’s Degree in a science-related field with previous medical writing responsibilities or Doctor of Philosophy (PhD) or PharmD with previous medical writing responsibilities 2+ years of experience in managing and directing complex and broad medical writing projects 2+ years of experience in global/regional regulatory medical writing for clinical studies, marketing authorization, and late phase procedures in accordance with International Council for Harmonization (ICH) E3 and E6 (R2) guidelines 2+ years of experience in medical communications writing Job Location This position will be located in the RTP, NC office of United Therapeutics. Currently this job is a hybrid role requiring at least three days per week in the office. In office requirements could increase based on business needs. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success. We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.

Manage patient advocacy and medical society relationships, support patient and healthcare professional education, collaborate cross-functionally, and lead patient engagement initiatives. | 8+ years pharmaceutical industry experience in patient advocacy or commercial roles, knowledge of compliance and regulatory frameworks, strong interpersonal skills, and ability to travel up to 30%. | California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who you are You are an empathetic person who combines strategic thinking with business sense, and you're passionate about making a real difference for patients. You enjoy working closely with both colleagues and external partners, building strong relationships rooted in trust and collaboration. You naturally spot the needs of patients and healthcare providers, and you love coming up with thoughtful, strategic ideas that turn those needs into meaningful solutions. The purpose of the Senior/Patient Advocacy & Medical Society Engagement Manager is to manage patient advocacy and medical society relationships within Global Medical Affairs, ensuring that patient perspectives are consistently integrated into medical strategies and activities. This includes building and maintaining strong partnerships with patient advocacy groups and professional medical societies to support education, scientific exchange, and meaningful collaboration. • Relationship management: Build, maintain, and strengthen relationships with patient advocacy groups and professional medical societies, healthcare professionals and other external stakeholders, serving as a trusted and collaborative partner • Patient advocacy: Support the development of and implement strategies that align with business objectives, therapeutic area priorities, and the needs of both patients and healthcare professionals, engaging patient advocacy groups and medical societies with exceptional business acumen and strategic insights • Advance patient and HCP education: Support and/or collaborate with patient advocacy groups and medical societies to address educational gaps within the assigned therapeutic area. Work with internal stakeholders to develop, support and deliver educational initiatives to enhance patient care. • Cross functional collaboration: Partner closely with internal teams such as: marketing, clinical development, medical affairs, public policy, and compliance to ensure that patient advocacy and medical society initiatives are integrated and supported throughout the organization • Attend patient advocacy and medical society related meetings and events and report back internally with actionable insights • Manage the United Therapeutics funding requests portal regarding charitable and sponsorship funding requests from patient advocacy organizations and medical societies • Represent patients and the patient advocacy function at various internal cross-functional team meetings • Provide study recruitment support and patient partnership • Enhance patient recruitment for research including clinical trials, medical affairs studies, HEOR studies, qualitative research, and human factors studies • Identify opportunities for United Therapeutics and patient advocacy organizations to collaborate on important initiatives that will benefit the patients we serve; examples include partnering on patient registries, app technology development, patient survey work, etc. • Explore opportunities to collaborate with patients directly on editorial/short form publications, highlighting the patient experience, in partnership with the Medical Communications group • Capture feedback from patients and their caregivers on United Therapeutics cross-functional activities with the primary focus of the effort to support a better understanding of the patients and how they think and feel; examples include patient advisory panels, patient surveys, qualitative medical research • Adhere to all patient advocacy related compliance documents and standard operating procedures and educate the organization on these policies, as necessary; write, edit, and approve internal documents as they evolve with the ever-changing external environment • Become actively involved in a Global Medical Affairs social media presence, partnering with relevant internal and external functions and organizations • Maintain deep understanding of external patient related guidance documents including FDA guidance on patient focused drug development (PFDD) and patient preference research; educate internal colleagues via training, etc. • Establish leadership presence in patient advocacy environment and effectively connect and communicate with internal and external stakeholders • Participate or lead patient reported outcomes (PRO) studies and incorporate into relevant clinical trials and studies • Serve as project manager over assigned areas Minimum Requirements Manager: • 8+ years of pharmaceutical industry experience in customer-facing roles such as: patient advocacy, communications and/or commercial functions with a Bachelor's Degree or • 6+ years of pharmaceutical industry experience in customer-facing roles such as: patient advocacy, communications and/or commercial functions with a Master's Degree • Knowledge of compliance and regulatory framework • Exceptional soft skills including empathy and thoughtfulness especially when talking/supporting/collaborating with patients • Ability to be proactive, resourceful and show initiative • Microsoft suite of products including Word, PowerPoint, Excel, Teams, One Drive • Skype, Zoom or other online platforms to host and lead meetings • In-depth knowledge of relevant laws, regulations, and practices • Ability to travel up to 30% Senior Manager: • 10+ years of pharmaceutical industry experience in customer facing roles such as: patient advocacy, communications, and/or commercial functions with a Bachelor's Degree or • 8+ years of pharmaceutical industry experience in customer facing roles such as: patient advocacy, communications, and/or commercial functions with a Master's Degree • Knowledge of compliance and regulatory framework • Exceptional soft skills including empathy and thoughtfulness especially when talking/supporting/collaborating with patients • Ability to be proactive, resourceful and show initiative • Microsoft suite of products including Word, PowerPoint, Excel, Teams, One Drive • Skype, Zoom or other online platforms to host and lead meetings • In-depth knowledge of relevant laws, regulations, and practices • Ability to travel up to 30% Preferred Qualifications • Master's Degree in a related field • 5+ years of experience demonstrating success in leading or supporting patient advocacy initiatives and/or medical society engagement Job Location United Therapeutics has the flexibility to hire this role remotely within the United States with a strong preference to candidates on the east coast. The salary for this position ranges from $134,000 to $190,000 per year. In addition, this role is eligible for the Company's short-term and long-term incentive programs. The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.