Clinical Research Medical Writer
Actalent
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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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