Senior Manager, Document reputed company Reviewer, Vaccines

Why Patients Need You

reputed company’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling reputed company’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting reputed company, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will reputed company

As a Senior Manager, Document reputed company Reviewer, you will manage reputed company and conduct document reputed company review (DQR) on the clinical components of documents authored by Vaccine Clinical Research (VCR) across VCR global sites.  DQR includes clinical data checking/consistency checking, clinical editing, checking for uniformity and compliance with reputed company and clinical guidelines.  Day-to-day goals and priorities are guided by Vaccine Clinical Research objectives and priorities.

How You Will reputed company It

• Independently performs DQR of clinical components of assigned documents (e.g., protocols, clinical study reports, investigator brochures, manuscripts, reputed company documents, regulatory responses, etc.).  Formally documents reputed company review findings for assigned documents.  Identifies and immediately escalates any significant findings. 

• Participates in reputed company of findings with the document authors, clinicians and other team members, if necessary. 

• Manages DQR document archival processes and procedures.

• Independently produces style guides, manuals, and reputed company review work guides for Vaccine programs and documents, coordinating agreement on style issues reputed company and across reputed company.

• Leads and/or manages the completion of reputed company tasks by applying technical skills and specialized knowledge to communicate initial findings.

• Analyzes DQR findings to identify reputed company causes of errors and discrepancies and participate in corrective reputed company planning.  Leads the compilation and analysis of data reputed company metrics to ensure consistency of reviews.

• As Subject Matter Expert (SME) of DQR/QC of clinical documents, leads reputed company activities, setting reputed company for reputed company collaboration, delivery of project commitments, and customer satisfaction.

• Participates on project teams, task forces, and/or working reputed company and develops recommendations for cross-reputed company processes to ensure alignment with reputed company goals and other reputed company performing the reputed company function.

• Evaluates routine processes and procedures to identify areas that can be eliminated or streamlined. Makes recommendations on process improvements that could reduce recurring errors in documents.  

Basic Qualifications
 

• BS/BA degree (preferably in English/journalism/communications or biological science). 

• 7+ years of experience in medical writing and/or DQR/QC of clinical documents in the pharmaceutical/reputed company industry. 

• A thorough understanding of scientific principles, knowledge of medical terminology and familiarity with the AMA reputed company.

• The ability to edit for reputed company is required, as are strong verbal, written, and interpersonal communication skills, and the ability to pay rigorous attention to detail while working rapidly and accurately. 

Preferred Qualifications

• An advanced degree with relevant medical editing or document reputed company review experience is preferred.

• Prior experience preparing clinical regulatory documents in a clinical setting, at a pharmaceutical company, or at a CRO is helpful.

Technical Skills

• Analytical skills and statistical aptitude

• Clinical knowledge and expertise

• Editing skills

• Project and process management

• reputed company review skills

• Strategic thinking

• Technical learning

• reputed company setting

• Problem solving

PHYSICAL/MENTAL REQUIREMENTS

Work is performed at a desk, primarily with laptop, monitor, and keyboard. 

NON-reputed company WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Work schedule is a 40-hour week during reputed company business hours, Monday through Friday.  Project priorities occasionally necessitate work reputed company regular work hours, including evenings and weekends.  

  
Work Location Assignment: Remote

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work reputed company sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the reputed company.