Lead Medical Writer

1 week ago

Durham, North Carolina, United States HUMACYTE GLOBAL INC Full time
Job Overview

DEPARTMENT: Clinical Operations

COMPANY: Humacyte Inc (Nasdaq: HUMA) is pioneering a groundbreaking biotechnology platform aimed at delivering universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems to enhance patient outcomes and revolutionize medical practices. The organization is focused on developing and manufacturing acellular tissues to address a diverse array of diseases, injuries, and chronic conditions. Humacyte's flagship product, a portfolio of Acellular Tissue Engineered Vessels (ATEVs), is currently undergoing late-stage clinical trials for various vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. Additional preclinical efforts are in progress for coronary artery bypass grafts, pediatric heart surgery, type 1 diabetes treatment, and numerous innovative cell and tissue applications. Notably, Humacyte's 6mm ATEV for AV access in hemodialysis was the first candidate to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also achieved FDA Fast Track designation. Furthermore, the 6mm ATEV for urgent arterial repair following extremity vascular trauma has been granted RMAT designation, with priority designation for vascular trauma treatment by the U.S. Secretary of Defense.

POSITION SUMMARY:

The Lead Medical Writer will take charge of drafting clinical and regulatory documents, including clinical protocols, clinical study reports, investigator's brochures, regulatory meeting requests, briefing documents, and summary modules for INDs and NDAs/BLAs.

Key Responsibilities:

  • Recognized as a scientific contributor and subject matter expert in the preparation of specific regulatory clinical documentation.
  • Utilizes knowledge of regulatory medical writing and therapeutic areas to support pipeline projects.
  • Represents medical writing in cross-functional teams.
  • Exhibits proficiency in writing, editing, and reviewing clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents in accordance with company and regulatory guidelines.
  • Interprets data and applies knowledge of regulatory, compliance, and scientific requirements to document preparation.
  • Manages medical writing projects, including the design, planning, and preparation of clinical documentation to support clinical development and trial activities.
  • Addresses challenges related to medical writing scope, seeks guidance from management and peers as necessary, and demonstrates negotiation and communication skills with project team members.
  • May mentor and provide guidance to junior team members or contract writers.
  • Engages in or leads initiatives aimed at enhancing medical writing processes and standards.
  • Performs other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

Essential qualifications for the Lead Medical Writer include:

  • Ability to independently prepare a subset of clinical regulatory documents, such as Clinical Study Reports (CSR), Investigator's Brochure (IB), clinical sections of Investigational New Drug Applications (IND)/Investigational Medicinal Product Dossier (IMPD), and Common Technical Document (CTD) in compliance with company guidelines and international regulations, presenting clinical data in a clear and concise manner.
  • Proven experience in medical writing, document, and project teams.
  • Technical proficiency in standard office applications (e.g., Microsoft Office, Adobe Acrobat) and shared document systems (e.g., Google Docs, SharePoint). Familiarity with structured content management concepts is preferred.
  • Demonstrated excellence in presentation, writing, and project management skills.

EDUCATION:

Minimum educational requirements for the Lead Medical Writer:

  • A degree in a life science, preferably related to pharmacy or medicine.
  • Bachelor's degree with 5+ years of experience; MS with 4+ years; or a doctoral-level degree (e.g., PhD, MD, DVM, DO, PharmD) with 3+ years of relevant experience.

COMPENSATION & BENEFITS:

  • 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

Humacyte is an equal opportunity employer 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. The statements in this position profile are intended to describe the general nature and level of work being performed by individuals assigned to this classification and are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified.

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