Document Review Specialist II – Senior Document Review Specialist

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Evaluates a variety of highly technical scientific documents produced internally or externally to guarantee quality standards that meet or surpass client expectations.

• Checks the scientific logic and clarity of documents by validating data in tables, listings, and figures against source documents, ensuring consistency with current regulatory standards and guidelines.

• Edits for precision, uniformity, and grammatical correctness.

• Adjusts timelines to accommodate unforeseen requests for priority reviews.

• Revises scientific language for usage, flow, clarity, and suitability for the intended audience.

• Proactively engages with authors to ensure alignment with unique preferences and sound scientific judgment.

• Maintains, communicates, and applies knowledge of current guidelines, templates, and industry standards.

⛳️ Requirements

• A Bachelor's degree or equivalent relevant formal academic/vocational qualification is required.

• Five years of experience in regulatory document review, including protocols, protocol amendments, clinical study reports, narratives, investigator brochures, regulatory responses, and submission modules (primarily Modules 2.5, 2.7.3, and 2.7.4).

• Experience in the pharmaceutical/CRO industry is preferred.

• Ability to concentrate on document specifics as well as the overall goals and messaging intent of the documents.

• Strong understanding of the methods, techniques, and procedures involved in medical writing tasks.

• Excellent analytical skills.

• Good familiarity with medical terminology, statistical concepts, GCP, guidelines (e.g., ICH), and the requirements of the FDA and other international regulatory agencies.

• Detail-oriented with a strong commitment to document quality; thorough and methodical.

• Proficient in oral and written communication with strong grammatical skills.

• Effective organizational and planning abilities.

• Strong interpersonal skills.

• Demonstrated ability to work efficiently in a team setting.

• Advanced computer skills and proficiency.

• Solid understanding of document management systems.

• Capable of performing well under pressure while remaining motivated.

• Able to work both independently and collaboratively within a culturally diverse, geographically dispersed team environment.

🏝️ Benefits

• A selection of national medical and dental plans, along with a national vision plan, including health incentive programs.

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.

• A minimum of 120 hours of paid time off (PTO), 10 paid holidays each year, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability according to company policy.

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan.

• Employees’ Stock Purchase Plan (ESPP) provides eligible colleagues with the opportunity to purchase company stock at a discount.