Easter Seals Jobs

Seeking 1 Medical Writer

100% Remote

Description:

This role will be supporting the NIH's Clinical Research Infectious Disease (CRID) program. CRID is a large project under NIAID/NIH, leads clinical trials around vaccines and infectious diseases “Clinical Research Infectious Disease” early phase I/II, some phase III, handful of observational studies, 100 active trials, 120 FTE effort annually.

• Independently writes and leads the development of CSRs which includes:

o CSR Shells (Sections 1-9)

o Key Messages Map

o CSR Statistical Text (Results only- Sections 10, 11, and 12)

• Closely interacts with statisticians (and other team members as applicable) in the development of key messages map and CSR statistical text.

• Drives the document preparation process, drafts and distributes documents for review, and incorporates/resolves comments with all reviewers.

• Holds comment resolution meetings, generates comment reports and uses QC checklists during the document drafting process.

• Participate in the review of:

o CSR Statistical Text (if the statistician is drafting the text)

o CSR versions 0.1, 0.2 and 0.3 (and as needed)

o CSR timelines (generated by the PL)

• Attend CSR kick off meetings and other meetings as needed.

Skills:

Clinical Study Reports, CSR, Tables, Figures, Listings, TFL, Early Phase, Regulatory Submissions, Protocol Review, Infectious Disease, PhD

Additional Skills & Qualifications:

Ability to work independently w/minimal oversight w/writing

Infectious Disease preferred, but not required

Strong understanding of regulatory docs, understanding of CSR sections

Must have early phase experience

4-5 years as a Medical Writer w/regulatory submissions and CSR development background

1-2 years if they have PhD or higher level degree

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.