Manager, Aggregate Reports Analyst

$93,500 - $155,900/Yr

Pfizer - New York, NY

Full-time - Mid Level

New York, NY

Chemical Manufacturing

About the position

In the role of Manager, Aggregate Analyst at Pfizer, you will play a pivotal role in connecting evidence-based medical decision support with colleagues and stakeholders to enhance health outcomes. Your primary responsibility will be to draft manuscripts on clinical studies and scientific reports for submission to regulatory agencies or company use. This includes creating summaries, monographs, comprehensive reviews, scientific exhibits, and other projects that require strong medical communication skills. Your expertise will be essential in ensuring that the documentation is scientifically sound and meets regulatory standards. You will leverage your planning skills to prepare forecasts for resource requirements and identify areas for improvement in products, processes, or services. With a comprehensive understanding of the principles, concepts, and theories of the discipline, you will work towards advancing new methodologies and concepts. Your leadership abilities will be crucial in facilitating agreements between different teams, ensuring that projects are executed efficiently and effectively. Your problem-solving skills will be instrumental in helping Pfizer achieve new milestones and improve patient care globally. You will provide guidance, lead or co-lead projects, and manage your time effectively to meet objectives. Additionally, you will drive document strategies and messages in collaboration with relevant project team subject matter experts, ensuring that all documents are generated in accordance with internal processes and standards, are submission-ready, and are appropriately stored in the document management system. You will verify the accuracy of document content using source documents, including clinical regulatory documents and data tables, figures, and listings. It is essential that medical writing deliverables conform to International Conference on Harmonization and other relevant regulatory guidelines. You may also lead a team of internal or external authors for complex projects, perform Quality Control (QC) reviews, and contribute to the training of colleagues on quality standards and processes. Building and sustaining constructive relationships within other Pfizer lines, including country organizations, will be a key aspect of your role.

Responsibilities

• Draft manuscripts on clinical studies and scientific reports for submission to regulatory agencies or company use.
• Create summaries, monographs, comprehensive reviews, and scientific exhibits.
• Prepare forecasts for resource requirements and identify areas for improvement.
• Advance new concepts and methodologies in the field.
• Facilitate agreements between different teams to ensure project success.
• Drive document strategies and messages in collaboration with project team experts.
• Ensure documents are generated in accordance with internal processes and standards.
• Verify accuracy of document content using source documents.
• Ensure medical writing deliverables conform to regulatory guidelines.
• Lead a team of internal or external authors for complex documents.
• Perform Quality Control (QC) reviews and manage QC projects.
• Contribute to the training of colleagues on quality standards and processes.
• Develop and sustain constructive relationships within Pfizer lines.

Requirements

• Bachelor's Degree in a relevant field.
• 5+ years' experience in document QC and/or medical writing in the pharmaceutical or biotech industry.
• Experience interacting with cross-functional study team members.
• Solid understanding of medical terminology and clinical trials.
• Excellent interpersonal and communication skills.
• Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives.
• Proficiency with computer applications (MS Office).

Nice-to-haves

• Master's degree in a relevant field.
• Experience with software commonly used to present and analyze data.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Paid vacation, holiday, and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage
• Participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of base salary
• Eligibility for long-term incentive program
• Relocation assistance may be available based on business needs.