DEPARTMENT: Clinical Operations
LOCATION: Durham, NC; Partially Remote
COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.
JOB SUMMARY:
The Senior Medical Writer will be responsible for writing clinical and regulatory documents such as clinical protocols, clinical study reports, investigator’s brochures, regulatory meeting requests and briefing documents, and summary modules for INDs and NDAs/BLAs.
In the role of the Senior Medical Writer:
- Is recognized as a scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation.
- Applies knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects.
- Represents medical writing in cross-functional teams.
- Demonstrates competence in writing, editing, and reviewing clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents per company and other guidelines.
- Interprets data and applies knowledge of regulatory/compliance/scientific requirements to document preparation.
- Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings.
- Solves problems associated with medical writing scope of work, seeks advice from management and others as needed, and exercises negotiation and communication skills with project team members.
- May participate in orientation and coaching of junior team members or contractor writers.
- Participates in or leads initiatives to improve medical writing processes and standards.
- Other Duties as assigned.
EXPERIENCE & QUALIFICATIONS:
Required experience and skills for Senior Medical Writer:
- Ability to prepare, with minimal supervision, a subset of clinical regulatory documents e.g., Clinical Study Reports (CSR), Investigator’s Brochure (IB), clinical sections of Investigational New Drug Application (IND)/Investigational Medicinal Product Dossier (IMPD) and Common Technical Document (CTD) according to company guidelines and international governmental regulations, and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
- Demonstrated participation in medical writing, document, and project teams.
- Technical expertise in typical office Applications (e.g., Microsoft Office, Adobe Acrobat) and in shared document systems (e.g., Google Docs, SharePoint). Familiarity with concepts of structured content management preferred.
- Demonstrated excellent presentation, writing, and project management skills.
Minimum education required for Senior Medical Writer:
- Degree in a life science, preferably related to pharmacy or medicine.
- Bachelor’s degree with 5+ years; MS with 4+ years; or doctoral-level degree (e.g., PhD, MD, DVM, DO, PharmD) with 3+ years of relevant career experience.
COMPENSATION & BENEFITS HIGHLIGHTS:
- Stock Options
- 401k Plan with 4% Match and no Vesting Schedule
- Medical, Vision and Dental Plans
- Company Paid Long Term/Short Term Disability
- Company Paid Life Insurance
- 23 Days Paid Time Off (PTO)
- 10 Company Designated Holidays + 2 Floating Holidays
- Paid Parental Leave Policies
** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. **
The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.
