Description:

The R&D Technical Writer will serve as a technical team member and will support the drafting of technical documents and development reports consistent with the project schedule.

Prepares written project documents, including reports, memoranda, and SOPs, protocols, batch records, etc.

Author and create submission content from source documentation for registrations and provide writing support for technical reports.

Use experience in Process Development to identify technical inconsistencies and participate in resolution.

Strong written and oral communication skills to summarize studies from reports, presentations, and notebooks and a demonstrated ability to document information in a clear and concise manner.

Skills:

technical writing, regulatory, fda, writing skills, sop, regulatory documents

Top Skills Details:

technical writing,regulatory,fda

Additional Skills & Qualifications:

Associates or Bachelor degree in chemistry, Chemical Engineering, Biochemistry, Biology, Life Sciences, or related field required.

3 or more years of relevant experience required.

Demonstrated knowledge of pharmaceutical manufacturing and process development

Knowledge of product lifecycle – Product and process development, validation, regulatory submissions, and commercial GMP manufacturing.

Demonstrated experience working with Microsoft Office programs (Excel, Word, PowerPoint, Visio, etc.).

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.