Associate Medical Writer / Medical Writer (Onsite, Research Triangle Park, NC) Job at United Therapeutics
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
Assists other authors or acts as the primary author to research, write, and edit several regulatory documents including (but not limited to) clinical study protocols and reports, Investigator's Brochures, and safety documents. Drafts scientific content for abstracts, posters, manuscripts, and slide presentations. Follows relevant SOPs and style guides and ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables and responds to findings. This is a hybrid position - 4 days/week onsite in the RTP, NC office, and 1 day a week work from home.
How you’ll contribute
Assists other authors or acts as the primary author to research, write, and edit several regulatory documents including (but not limited to) clinical study protocols and reports, Investigator's Brochures, and safety documents. Drafts scientific content for abstracts, posters, manuscripts, and slide presentations. Follows relevant SOPs and style guides and ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables and responds to findings. This is a hybrid position - 4 days/week onsite in the RTP, NC office, and 1 day a week work from home.
- Assist lead author or be primary author for documents that are within scope, which includes, but is not limited to: clinical study protocols, ICF, CSR, clinical narratives, IBs, PBRER/DSUR, sections for regulatory submissions, internal protocols and reports and abstracts/manuscripts.
- Liaise with other departments (including but not limited to: Data Management, Program Heads, Medical Monitoring, Regulatory, Safety) to gather data for the above-mentioned reports.
- Prepare presentations/meeting posters as needed.
- Develop and maintain tracking for the above-mentioned documents.
- Update SOPs as needed.
- Assist in writing technical reports, regulatory briefing documents, and other documents to support product development.
- Collaborate with other writers to ensure consistency and unity of message and style among sections in a single document or in multiple related documents.
- Perform other duties as required.
For this role you will need
Minimum Requirements
- Bachelor’s degree in arts/sciences (BA/BS) in a science-related field
- For Associate Medical Writer level:
- 1+ years of experience in medical writing
- For Medical Writer level:
- 2+ years of experience in medical writing
- 1+ years of experience in managing and directing complex medical writing projects
- 1+ years of experience in global/regional medical writing/regulatory affairs for clinical studies, marketing authorization and late phase procedures
- Excellent interpersonal skills
- Attention to detail
- Proficiency with Microsoft Word, Excel, and PowerPoint
Preferred Qualifications
- Master’s degree (MA/MS/MBA) with previous medical writing responsibilities or
- Doctor of Philosophy (PhD) with previous medical writing responsibilities or
- Doctor of Pharmacy (PharmD) with previous medical writing responsibilities
- For Medical Writer level: 1+ years of experience in regulatory medical writing
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
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