California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .

The job details are as follows:

What We Do

We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.

How you’ll contribute

The Project Manager of Medical Affairs will coordinate operations of ongoing studies and other departmental initiatives, meeting required timelines and adhering to budget, quality and performance expectations. This person contributes to the successful completion of assigned projects, including clinical studies, registries, retrospective chart reviews, or other strategic study/departmental initiatives.

• Coordinate operations of clinical trial(s) from study start-up to close-out including ensuring study conducted in accordance with appropriate SOPs, ICH/GCP Guidelines and local regulations; coordinating and managing resources assigned to the study; and managing study budget, timelines, quality and performance expectations

• May serve as primary study contact for all or specific responsibilities during study/project, including regular conference calls and team meetings with appropriate functional areas, management and vendors as necessary

• Support insourcing/outsourcing partners to ensure they meet the required standards and expectations

• Contribute to study concept, protocol, clinical study report as well as other critical study documents as required

• Facilitate vendor management, inclusive of selection, negotiation, implementation and management of vendor’s Statements of Work/Scope of Work (SOW)

• Support the planning, management and reporting on all strategic study initiatives through oversight of cross-functional study activities, providing regular study updates to project team leads, if applicable

• Identify, resolve or escalate risks and issues involving study timelines and deliverables

• Collect, track and report Key Performance Indicators (KPIs) such as query resolution, AE/SAE data collection, drug reconciliation/shipment, site and patient enrollment, etc. to company stakeholders

• Collaborate with team to ensure adequate protocol related and process training of all study team members; manage protocol deviations/violations to ensure proper documentation and proactively work with CRO and/or Investigative sites to reduce their occurrence

• Assist with preparation for interim and primary analysis reports, as applicable

• Provide first tier support for protocol, SOP and system questions

• Contribute to process evaluation, development, and improvement, as applicable

• Perform other duties as assigned

For this role you will need

Minimum Requirements

• Project Manager: Bachelor’s Degree with 2+ years of project management experience in overseeing clinical trials in pharmaceutical environment (or equivalent combination of experience and education) and 2+ years of experience in the pharmaceutical industry

• Senior Project Manager: Bachelor’s Degree with 5+ years of project management experience in overseeing clinical trials in pharmaceutical environment (or equivalent combination of experience and education) or Master's Degree with 3+ years of project management experience in overseeing clinical trials in pharmaceutical environment (or equivalent combination of experience and education) and 5+ years of experience in the pharmaceutical industry

• Ability to interact and communicate effectively, both verbally and in writing, with colleagues and management, both within and outside medical affairs including upper management, Key Opinion Leaders, vendor personnel, clinical investigators and site personnel

• Study planning and set-up, maintenance, and close-out experience

• Vendor management experience

• Experience in biopharmaceutical industry with phase IV trials

• Strong working knowledge and ICH/GCP regulations and guidelines

• Good overall scientific and clinical/medical research background

• Experience and comfort with and working both independently and part of a multifunctional team

• Commitment and ability to handle high workloads, demanding situations and deadlines

• Ability to proactively identify potential issues and formulate potential course(s) of action

• Proficient in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint)

• Ability to travel up to 25%

Preferred Qualifications

• Master’s Degree in scientific discipline (PharmD, MPH, MA/MS)

• Certified Project Management Professional (PMP)-PMI

• ACRP or other GCP related certifications

• Proficient in Microsoft Project, SmartSheet, and Electronic Data Capture (EDC) systems (e.g. Medidata)

At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.

While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / 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.