Opportunities

Medical Affairs Associate (Irvine)

Who We Are:

AVITA Medical is a Class III medical device company looking for a full-time Medical Affairs Associate to help sustain our expanding line of indications. AVITA is headquartered in Valencia, CA, and manufactures in Ventura, CA. Come join our team and be part of our growth!

What We Are Looking For:

The Medical Affairs Associate is a key contributor to the company’s Medical Affairs Department with responsibility for assisting in the development and maintenance of medical information and communications.  This individual will help create fair and scientifically balanced materials for healthcare professionals, regulatory bodies, internal employees, and investors.

Duties/Responsibilities

  • Provide data analysis and medical writing support to internal and external stakeholders
    • Work closely with MSL team to assist in the submission of abstracts and publications
    • Assist development of Clinical Study Presentations (SIVs, Investigator Meetings, and Data Readouts)
  • Lead medical affairs activities for Post Market Surveillance
  • Maintain internal documents including bibliography, medical communication strategy, and abstract trackers
  • Support response to HCP, consumer, and Investor product/medical inquires

Special Knowledge/Skill

  • Excellent written and oral communication skills
  • Advanced knowledge of Microsoft word, PowerPoint, and Excel
  • Understanding of clinical trial design, protocol development, regulatory pathways, and medical communication strategy
  • Ability to work independently and as a member of a team
  • Capable of managing multiple projects simultaneously

Experience

  • Medical writing (study protocols, data analysis, abstracts, posters, manuscripts, presentations)
  • Post-market surveillance programs for regulatory bodies
  • Unsolicited requests for information, off-label request process

Education/Training

  • Advanced degree in medical field, life sciences, or public health preferred

Travel Expectations

  • Up to 15% travel may be required for conference attendance, HCP engagement, and in-person corporate meetings

Position Location

  • US

Information Security Compliance

AVITA Medical recognizes the role of information security in ensuring that users have access to the information they require to carry out their work in a secure manner.  AVITA Medical is committed to protecting the security of its information and information systems.  As such, each role within AVITA Medical must demonstrate the same commitment to information security.

IMPORTANT SAFETY INFORMATION (United States)

INDICATIONS FOR USE: The RECELL® Autologous Cell Harvesting Device is indicated for the treatment of acute thermal burn wounds. The RECELL® device is used by an appropriately-licensed healthcare professional at the patient’s point of care to prepare autologous RES® Regenerative Epidermal Suspension for direct application to acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients.

CONTRAINDICATIONS: RECELL® is contraindicated for: the treatment of wounds clinically diagnosed as infected or with necrotic tissue, the treatment of patients with a known hypersensitivity to trypsin or compound sodium lactate (Hartmann’s) solution, patients having a known hypersensitivity to anesthetics, adrenaline/epinephrine, povidone-iodine, or chlorhexidine solutions.

WARNINGS AND PRECAUTIONS: Autologous use only. Wound beds treated with a cytotoxic agent (e.g., silver sulfadiazine) should be rinsed prior to application of the cell suspension. RECELL® is provided sterile and is intended for single-use. Do not use if packaging is damaged or expired. Choose a donor site with no evidence of cellulitis or infection and process skin immediately. A skin sample should require between 15 and 30 minutes contact with Enzyme. Contact in excess of 60 minutes is not recommended. RECELL® Enzyme is animal derived and freedom from infectious agents cannot be guaranteed.

PRECAUTIONS: RECELL® is not intended for use without meshed autograft for treatment of full-thickness burn wounds. The safety and effectiveness of RECELL® without meshed autograft have not been established for treatment of partial-thickness burn wounds: on the hands and articulating joints, >320 cm2, in patients with wounds totaling >20% total body surface area (TBSA). The safety and effectiveness of RECELL with autografting have not been established for treatment of full-thickness burn wounds: on the hands and articulated joints, and in patients younger than 28 days of age (neonates).

SPECIAL PATIENT POPULATIONS: The safety and effectiveness of RECELL® have not been established for treatment of acute thermal partial-thickness burn wounds in pediatric patients younger than 18 years of age.

For complete Important Safety Information, refer to Instructions For Use. Please be aware that any indication for RECELL® outside of the United States may differ from the US indication. Please see the Instructions for Use for each country for the specific indication of RECELL®.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to AVITA, its subsidiaries or affiliates. No use of any AVITA trademark, trade name, or trade dress in this site may be made without the prior written authorization of AVITA, except to identify the product or services of the company.
©Copyright 2022 AVITA Medical. All Rights Reserved.
Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to AVITA, its subsidiaries or affiliates. No use of any AVITA trademark, trade name, or trade dress in this site may be made without the prior written authorization of AVITA, except to identify the product or services of the company.
©Copyright 2022 AVITA Medical. All Rights Reserved.