Integra LifeSciences

Returning Candidate?

Medical Writer

Medical Writer

Vacancy ID 
Position Type 
Regular Full-Time
Medical Affairs

More information about this job


Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.


Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery.  In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.

Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."



Responsible for Global Clinical Affairs medical writing activities including management of outsourcing activities. This includes responsibility for authoring, reviewing, editing, and tracking of various technical documents such as Clinical Evaluation Reports, Clinical Study Reports, Publications/Manuscripts, Health Hazard Risk Assessments/Risk-Benefit Analysis, Investigator’s Brochures, Annual Reports to Regulatory Agencies, sections of documents for regulatory agency submission such as Investigational Device Exemptions (IDE)/premarket approval applications (PMAs), and literature review/report for marketing support.



To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.


Primary responsibilities are to:

    • Manages the document writing process collaborating with internal and external personnel for various Global Clinical Affairs and regulatory support documents as noted above.
    • Creates content: writes new content, makes changes/edits to existing content.
    • Analyzes data from various sources; able to analyze, interpret, and critically evaluate clinical and nonclinical data and communicate to technical and non-technical stakeholders.
    • Preparation of pre-clinical and clinical sections for regulatory documentation, such as IDE, PMA, IND, or CE-Mark Technical Dossier.
    • Develops tools and templates. Ensures template sections of documents remain current and consistent across documents/Business Units as applicable.
    • Develops and maintains tools to track document status to ensure reporting requirements are met.
    • Manages and tracks the authoring and submission of manuscripts and publications to various journals and conferences. Develops posters, slides, and supporting materials as required.
    • Maintains basic to advanced knowledge of the businesses’ products and the therapies in which they are used.
    • Maintains general knowledge of industry, regulatory, marketing, linguistic, and publication standards and applies this knowledge to the completion of all projects.
    • Partners with subject matter experts to develop technical content that meets regulatory requirements, and to achieve specific and immediate business objectives.
    • Forecasts and meets project deadlines and budgets. Takes the initiative to report on project status; anticipates and alerts manager and internal customers of potential project difficulties.
    • Develops and maintains effective working relationships with co-workers, internal customers, and external vendors.
    • Participates in department activities and contributes to a teamwork environment, operating according to the groups agreed upon expectations.



The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

    • Education: Bachelor’s degree in scientific discipline or local equivalent is required and equivalent experience sufficient to successfully perform the essential functions of the job may be considered. PhD in a scientific discipline preferred.
    • Certifications: None
  • Experience: Minimum 2 years technical writing experience in the medical device or pharmaceutical industry. Knowledge of regulatory requirements and documents, both U.S. and International.

Need help finding the right job?

We can recommend jobs specifically for you! Click here to get started.