The job details are as follows:

What We Do
United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.

We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.

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, pediatric cancers and other orphan diseases.

In 2021, we became 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.

How you’ll contribute
Assist in the electronic and physical creation, control, review, approval, distribution, and administration of controlled documents. Provide technical writing assistance to various areas of the organization. Act as Quality reviewer of documents and in-process clinical procedures. Ensure compliance to applicable company policies, standards and regulations. This is a hybrid position - 3 days/week onsite in the Silver Spring, MD office, and 2 days a week work from home.

• Manage the life cycle of controlled documents in the electronic document management system (document creation, revision, archival, retention and withdrawal/retirement)
• Work within the electronic document control system (MasterControl) to generate new documents or revise documents/procedures and coordinate document workflows
• Circulate proposed and final versions of proposed documents for review, coordinating with all appropriate departments to ensure correct departments are involved in the review and approval process
• Work with document owners to ensure document collaboration is effective and efficient.
• Maintain control and maintenance of files in Document Control area
• Prepare & assist in document archival, retrieval and destruction of records per cGMP regulations
• Ensure timeliness of record access and retrieval, identification, protection, and structure
• Manage, store, and track GXP documents per current GXP regulations and internal procedures
• Prepare process and status reports, assign and monitor document numbers, and review documents for accuracy and completeness
• Implement and coordinate periodic document reviews
• Prepare, review and issue records, protocols, logbooks, and other requested GXP documents in accordance with company policies, quality systems and government regulations as directed
• Maintain the electronic and physical organizing, scanning, indexing, filing, storage and record keeping of GXP quality records (and other controlled documents as necessary) in compliance with company policy and regulatory standards
• Act as technical writer, assisting all functional areas with creation/revision of content for controlled documents
• Ensure document content is developed/prepared and suitable for Quality review/approval
• Review controlled documentation (clinical case records, laboratory data, logbooks, forms, etc.) for accuracy, completeness, and compliance with Lung Bioengineering policies, procedures, and GMP/QSR/Clinical Trial requirements
• Provide real-time review of case related data-this requires after-hours, 24/7 availability when on call for procedure/data review but can be done remotely
• Perform all other duties as required

For this role you will need
Minimum Requirements

• Associate degree and 4+ years of relevant experience in an FDA regulated industry such as pharmaceutical, medical device, biotech, and etc., OR
• 1+ years of experience performing in Quality or Document Control functions
• Excellent organizational skills and attention to detail
• Experience with eDMS systems in pharmaceuticals and/or biotech (experience in MasterControl preferred)
• Knowledge of good documentation practices and procedures
• Ability to operate efficiently and effectively in a fast-paced environment
• Experience in writing technical documents (SOP, Policy, Work Instructions)
• Experience in review of quality documentation (completed forms, logs, data sets)
• Working knowledge of GMP basics, FDA guidance, and industry best practices
• Hands-on knowledge with issuing GXP records, logbooks, and/or other controlled documents

Preferred Requirements

• Bachelor’s degree in Arts/Sciences (BA/BS) and 2+ years of relevant experience in an FDA regulated industry such as pharmaceutical, medical device, biotech, and etc. with a bachelor's degree and

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

Job Type: Full-time

Schedule:

• Monday to Friday

Work Location: Hybrid remote in Silver Spring, MD 20910

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