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Pharmaceutical Documentation Writer Jobs (NOW HIRING)

GardaWorld

Clinical Pharmacist

Surprise, AZ · On-site

$75/hr

... and pharmaceutical documentation in compliance with DEA, HIPAA, and facility requirements ... Must be able to read, write, speak, and understand English proficiently. * Must be at least 21 ...

GardaWorld Group

$75/hr

... and pharmaceutical documentation in compliance with DEA, HIPAA, and facility requirements ... Must be able to read, write, speak, and understand English proficiently. * Must be at least 21 ...

GardaWorld

Clinical Pharmacist

Surprise, AZ · On-site

$75/hr

... and pharmaceutical documentation in compliance with DEA, HIPAA, and facility requirements ... Must be able to read, write, speak, and understand English proficiently. * Must be at least 21 ...

GardaWorld

Clinical Pharmacist

Surprise, AZ · On-site

$75/hr

... and pharmaceutical documentation in compliance with DEA, HIPAA, and facility requirements ... Must be able to read, write, speak, and understand English proficiently. * Must be at least 21 ...

Eldridge Writing

Apprentice Medical Writer

Raleigh, NC · On-site +1

... pharmaceutical and biotechnology clients. We pride ourselves on unwavering quality, dependable ... Craft and meticulously review regulatory documents, such as clinical study reports, protocols, and ...

New

CEDENT

Technical Writer

Springfield, NJ · On-site

... Pharmaceutical Technical Writer to join our team. The ideal candidate will be responsible for creating, revising, and maintaining various controlled documentation that complies with Good ...

AA2IT

Documentation Specialist

Durham, NC · On-site

$29.50/hr

... vaccine/pharmaceutical industry Working knowledge of documentation administration including the writing, review, and approval of documentation in a GMP industry Responsibilities: Provide ...

Medicine Journal

Pharmacist-PRN

Chattanooga, TN · On-site

$53 - $63.75/hr

This is accomplished through the provision of appropriate drug therapy and clinical pharmaceutical ... Documents Clinical Interventions. Appropriately processes all medication orders following ...

Tjoapack

Validation Writer

Clinton, TN · On-site

The Role As a Validation Writer , you are a key member of the Technical Services team, responsible for developing FDA- and GMP-compliant documentation supporting primary and secondary pharmaceutical ...

Tjoapack

Validation Writer

Clinton, TN · On-site

The Role As a Validation Writer , you are a key member of the Technical Services team, responsible for developing FDA- and GMP-compliant documentation supporting primary and secondary pharmaceutical ...

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Pharmaceutical Documentation Writer information

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How much do pharmaceutical documentation writer jobs pay per hour?

As of Sep 13, 2026, the average hourly pay for pharmaceutical documentation writer in the United States is $38.64, according to ZipRecruiter salary data. Most workers in this role earn between $26.20 and $48.80 per hour, depending on experience, location, and employer.

What is a pharmaceutical documentation writer?

Pharmaceutical documentation writers are professionals who specialize in creating and managing a wide range of documents required in the pharmaceutical industry. They are responsible for drafting, reviewing, and ensuring the accuracy and compliance of documents such as regulatory submissions, clinical study reports, standard operating procedures (SOPs), and drug approval dossiers. Their work ensures that all documentation meets industry standards and regulatory requirements, facilitating the safe and effective development and approval of medications. These writers often collaborate with scientists, regulatory teams, and quality assurance professionals to gather information and ensure clarity and consistency in all documents.

What are the key skills and qualifications needed to thrive as a pharmaceutical documentation writer?

To thrive as a Pharmaceutical Documentation Writer, you need a solid background in life sciences or pharmacy, strong writing skills, and familiarity with regulatory guidelines such as ICH and FDA standards. Proficiency with document management systems, MS Office Suite, and electronic submission platforms is typically required. Attention to detail, organization, and the ability to communicate complex information clearly are standout soft skills in this role. These competencies ensure that documentation is accurate, compliant, and easily understood, which is crucial for regulatory approval and patient safety.

What are the typical challenges faced by a pharmaceutical documentation writer when collaborating with cross-functional teams?

Pharmaceutical Documentation Writers often work closely with scientists, regulatory affairs, and quality assurance teams to produce accurate and compliant documents. A common challenge is ensuring that highly technical or scientific information is translated clearly while meeting strict regulatory guidelines. Balancing input from multiple stakeholders and managing tight deadlines can also be demanding. Strong communication and organizational skills are essential to navigate these complexities and ensure documentation aligns with both company and regulatory standards.

What is the difference between Pharmaceutical Documentation Writer vs Regulatory Affairs Associate?

AspectPharmaceutical Documentation WriterRegulatory Affairs Associate
Required CredentialsBachelor's in life sciences, technical writing skillsBachelor's in life sciences, understanding of regulations
Work EnvironmentPharmaceutical companies, CROs, biotech firmsRegulatory agencies, pharmaceutical companies
Employer & Industry UsageUsed for preparing SOPs, clinical documents, and reportsInvolved in submission processes, compliance, and regulatory strategy
Common Search & Comparison IntentUnderstanding documentation roles in pharmaRegulatory processes and compliance roles

The Pharmaceutical Documentation Writer primarily focuses on creating and editing technical documents, reports, and SOPs within pharmaceutical companies. In contrast, a Regulatory Affairs Associate handles regulatory submissions, compliance, and liaising with authorities. While both roles require knowledge of pharmaceutical processes, the Documentation Writer emphasizes technical writing, whereas the Regulatory Affairs Associate concentrates on regulatory strategy and submissions.

What is documentation in the pharmaceutical documentation writer industry?

In the pharmaceutical documentation writer industry, documentation refers to the creation, review, and management of detailed records such as clinical trial reports, regulatory submissions, standard operating procedures, and manufacturing documentation. These documents ensure compliance with regulatory standards like FDA or EMA requirements and are essential for product approval and quality assurance. Writers often use specialized tools and must have a strong understanding of pharmaceutical regulations and scientific terminology.

What are popular job titles related to Pharmaceutical Documentation Writer jobs?

For Pharmaceutical Documentation Writer jobs, the most frequently searched job titles are:

Infographic showing various Pharmaceutical Documentation Writer job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 2% As Needed, 78% Full Time, 16% Part Time, and 3% Contract. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution, with an average salary of $80,364 per year, or $38.6 per hour.

Documentation Specialist

Bedford, OH • On-site

Hikma Pharmaceuticals
Pharmaceutical Product Wholesalers • 5 - 10K employees
Learn more about Hikma Pharmaceuticalsexternal

$21/hr

Other

Posted 19 days ago

Hikma Pharmaceuticals rating

7.8

Company rating: 7.8 out of 10

Based on 31 frontline employees who took The Breakroom Quiz

Job description

Documentation Specialist

We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Documentation Specialist. In this role, you will be responsible for processing and reviewing executed batch records in Operations. Batch records must be reviewed for accuracy in compliance with cGMP, FDA regulations and policies. Additional responsibilities will include assisting in update/revisions of manufacturing Standard Operating Procedures and the tracking of the document approvals through the VEEVA document system.

Key Responsibilities:
  • Regular and predictable onsite attendance and punctuality.
  • Accurately review and approve executed production batch records and associated batch related documents.
  • Accurately arrange the documents in a batch record.
  • Revise/update Standard Operating Procedures pertaining to the Operations group.
  • Maintain acceptable cGMP and Safety training level. This includes maintaining Job specific curriculum training at least 95% complete, attending and passing cGMP training sessions.
  • Assist the Operations department in deviation investigation through documentation of findings
Qualifications

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

Education:
  • Minimum: High School diploma or equivalent is required.
  • Preferred: Associate of Science
Experience:
  • Minimum:
    • One or more years' experience in healthcare/pharmaceutical product manufacturing or quality assurance.
    • Strong background in pharmaceutical documentation and strong knowledge of cGMPs/FDA regulations
Skills:
  • Ability to write, revise and review SOPs
  • Strong interpersonal skills and great attention to detail are necessary
  • Proficient in Microsoft Office applications (Word and Excel)
  • Good communication skills both verbal and written
  • Good time management skills and the ability to multitask and work independently
  • Strong ability to cope with the stress associated with changes in the daily production schedule
  • Must have history of strong documentation skills and attention to detail.
  • Familiarity with cGMPs and CFR.
  • Good organizational skills and ability to multi-task and perform work in a timely manner.
  • Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, department management and production personnel.
  • Basic knowledge of computer systems at a proficient level to navigate input and/or reference computerized data.
  • Ability to read and understand documents such as production batch records, safety rules, corporate guidelines and standard operating procedures.
Compensation

Hourly Rate: $21.00 per hour. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

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