Technical Writer Scientific II Associate

Primary Talent Partners; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading recruitment firm is seeking a Technical Writer/Scientific - II to join a pharmaceutical client in West Point, PA. This is a fully remote role with a 9-month contract that could be extended. The candidate will focus on authoring and reviewing Analytical Test Methods and regulatory documentation while collaborating within a multidisciplinary team. A BS/BA in life sciences/engineering and at least 2 years of experience in a cGMP environment are required. Excellent communication skills are essential. The position is also open for hybrid options.

Benefits

Remote work

Potential for extensions

Qualifications

• Minimum 2 years of experience in a cGMP laboratory environment.
• Experience in biopharmaceutical manufacturing, especially in biologics or vaccines.
• Detail-oriented with excellent writing skills.

Responsibilities

• Author and review technical documents for regulatory filings.
• Ensure compliance with current cGMP practices.
• Collaborate with multidisciplinary teams.

Skills

Technical writing

Good Manufacturing Practices (cGMP)

Analytical Test Methods

Collaboration

Strong written communication

Education

BS/BA in life sciences/engineering

Master's degree/PHD

Tools

MS Office

Document repository systems

Job description

Primary Talent Partners has a new contract opening for a Technical Writer/Scientific - II (Associate) to join our pharmaceutical client in West Point, PA. This is a fully remote, 9-month contract to start with the potential for extensions.

Pay

$38.00 - $48.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.

Schedule

Remote, M-F

Description

We are seeking a technical writer who will author and review Analytical Test Methods to commercialize procedures for the QC testing area by working closely with method experts.

• The candidate may also author and review documents supporting regulatory submissions working closely with regulatory groups.
• The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.

Primary Responsibilities

• Authoring and critically reviewing technical documents including Regulatory Filing sections and Analytical Test Methods.
• Authoring and reviewing documentation compliant with current Good Manufacturing Practices (cGMP), including Second Person Review or Second Scientist Review.
• Participate in group initiatives related to document standards, template development, internal processes, and other aspects of document management.
• Collaborate closely with key stakeholders.

Education

• Minimum qualification - BS/BA in life sciences/engineering is required
• Master's degree/PHD preferred

Required Experience and Skills

• At least 2 years working experience in a cGMP laboratory environment.
• Experience in the biopharmaceutical manufacturing industry, such as in biologics or vaccines commercialization, technical operations, or quality control.
• Strong oral and written communication skills.
• Work independently and within cross-functional teams.
• Maintain a proactive and service-oriented mindset.
• Experience with MS Office and document repository systems.

Preferred Experience and Skills

• Experience with analytical method validation and transfer according to ICH and USP guidelines.
• Experience with laboratory data management systems

Software skills

MS office suite

Personality

• Detail oriented
• Excellent writing skills
• Collaborative
• Good communication and interpersonal skills.

Notes

• Remote opportunity.
• Work location: West Point, PA is an option for candidate who are local and want to work from office (hybrid).
• Positions: 2

Primary Talent Partners is an Equal Opportunity / Affinity Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at [e-mail].

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