Job title: Manager Aggregate Report Analyst
Job description: Why Patients Need You
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
What You Will Achieve
Your strong documentation skills will be an asset for the team. You will help us draft manuscripts on clinical studies and scientific reports for submission to regulatory agencies or in-company use. You will also help with summaries, monographs, comprehensive reviews, scientific exhibits and projects requiring skill in medical communication.
Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.
It is your problem solving ability that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the division.
- Drive document strategies and messages in a collaborative way with relevant project team subject matter experts.
- Ensure documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system.
- Verify accuracy of document content using source documents including clinical regulatory documents and data tables, figures, and listings.
- Ensure that medical writing deliverables conform to International Conference on Harmonization and other relevant regulatory guidelines.
- Lead a team of internal or external authors if multiple or complex documents are required for a particular project.
- Understand relationships and dependencies between documents and analyses produced for regulators.
- Independently perform Quality Control (QC) review and manage QC projects in accordance with agreed upon timelines.
- Contribute to the training of colleagues on quality standards and processes.
- Develop and sustain constructive relationships within other Pfizer lines including country organizations.
- Record findings and identify appropriate corrections to address findings.
- Bachelor’s Degree
- 5+ years’ experience
- Demonstrated experience in document QC and/or medical writing in the pharmaceutical or biotech industry
- Experience in 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)
- Master’s degree
- Experience with software commonly used to present and analyze data
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Location: Chennai, Tamil Nadu
Job date: Thu, 17 Feb 2022 00:43:15 GMT
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