Clinical Research Medical Writer-Must have 2 years of industry experience

Prepare scientific and regulatory documents for submission to the FDA; this includes Investigational New Drug applications, annual reports, preclinical and clinical

study reports, safety reports, and investigator's brochures

Perform literature searches and prepare summaries of results

Prepare meeting reports and proceedings, safety documents, or data analysis

Contribute o technical proposals and respond to technical questions

 

Qualifications

2+ years of clinical research medical writing industry experience

Knowledge of regulatory requirements for clinical studies

Strong writing skills requiring moderate to minimal editing

Strong software skills including Microsoft Office products and reference management software

Ability to analyze medical research data and review experimental protocols

Experience in Infectious Disease and Clinical Research

Experience with IND and Regulatory reports

Ability to work with minimal supervision

Experience in Oncology therapeutic area is advantageous

Experience with medical devices is acceptable

Schedule

The hybrid schedule will be 3 days remote and 2 days onsite.  

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.