Medical Writer jobs in Hoboken, NJ

Description:

Prepare questions of clinical study design in meeting request document

Review the pre-IND meeting-related files, including the meeting request letter, meeting package

Prepare clinical study questions and supporting files for the briefing package

Review and revise the clinical study synopsis

Reply meeting minutes/WRO responses (clinical/medical related issues)

Review general investigational plan

Review clinical study full protocol

Prepare ICF

Work with sponsor to address any additional inquiries from the FDA during 30-day IND

Review IB

Additional Skills & Qualifications:

Must have an expert level in MW and be able to be a 1099 consultant

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.