Part Time ( 20 Hrs ) Medical Writer Opening!

Job Description

The position focuses on early phase I/II, some phase III, and a few observational studies. The Medical Writer will develop protocols, manuscripts, and ICF documents to further research against cancer for those infected with HIV/AIDS globally.

Responsibilities

• Review and author protocols, manuscripts, and ICF documents.
• Serve as the primary author on regulatory documents and clinical study reports (CSR).
• Produce clear, concise, and effective written and verbal communications describing scientific and clinical data.
• Develop expert knowledge of US and international regulations, requirements, and guidance associated with clinical regulatory document preparation and submissions.
• Collaborate with team members to resolve comments and produce high-quality final documents.
• Analyze, synthesize, and compile data from a broad range of disciplines.
• Prioritize tasks and work simultaneously on multiple projects, meeting critical deadlines.
• Use Common Technical Document content templates and manage electronic document systems.

Skills Needed

• PhD in Oncology or Infectious Disease.
• 4-5 years of experience as a Medical Writer with regulatory submissions and CSR development background or 1-2 years with a PhD or higher degree.
• Strong understanding of regulatory documents and clinical product development.
• Knowledge of clinical research, study design, biostatistics, medical terminology, research methodology, and the regulatory environment including FDA/ICH guidelines and GXP/ICH/CTD principles.
• Expertise with medical terminology and research methodology.
• Ability to work independently with minimal oversight.
• Experience in a fast-paced, cohesive, collaborative team-oriented work environment.

Work Environment

100% remote work environment with no onsite requirement. The team is small and works alongside a cross-functional team of statisticians.

Pay and Benefits

The pay range for this position is $55.00 - $75.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Mar 28, 2025.

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.

Salary : $55 - $75