Description:

Supervise regulatory writing vendors to manage submission documents and ensure the science-supported clinical messaging is clear and concise and is fully aligned with program team strategy.

Collaborate with cross functional teams providing timelines and overall medical writing document management Support and guide all clinical regulatory documents to be included in eCTD submissions and other global health authority (HA) submission types, including all original applications, information requests, amendments, responses, and all other clinical submission types.

Skills:

Technical writing, Medical writing, Medical, Regulatory

Additional Skills & Qualifications:

3 years of regulatory document project management oversight/experience. Proven experience in medical/clinical/regulatory writing in the pharmaceutical / biotechnology / healthcare industry a plus.

Solid understanding of statistical concepts and techniques including understanding of scientific content with the ability to interpret into final submission-ready documents.

Knowledge and expertise with Common Technical Document structure and content templates, electronic document management systems and information technology. Excellent working knowledge of software programs in Windows environment.

Experience Level:

Intermediate Level

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.