Part Time Clinical Research Regulatory Technical Writer

Description:

Regulatory Affairs Technical Writer to provide SOP development support. Experienced technical writer who can support 20-30 hours per week for 6 months with the possibility of extension.

Job Description:

• Serve as a primary author for SOPs relating to Regulatory Affairs.

• Facilitate the evaluation/creation/revision of processes in GRA.

• Provide best practice guidance in compliance with ICH guidelines .

• Provide creation of the process maps and build consensus with the SOP and GRA team.

• Host and facilitate meetings with SMEs and internal/external stakeholders preparing and recording meeting minutes.

• Provide training of newly approved procedures.

• Provide leadership of creation and use of the templates in place.

• Support the SOP team as necessary in writing the SOPs and work constructions.

• Interacts cross functionally with charters

• Solution oriented.

Expected Deliverables:

• New/Revised SOPs, Wis that are created you the technical writer in a timely manner.

o Facilitate the evaluation/creation/revision of processes in GRA.

o Creating process maps, drafting SOPs, lead review and approval process as well as training/roll out steps

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.