What are the responsibilities and job description for the Sr Manager, Aggregate Report Document Management position at Alnylam?
Summary of Key Responsibilities
Responsibilities :
- Manage the end-to-end process of aggregate report generation, including data collection, quality control, and submission to regulatory authorities.
- Responsible for overall quality assurance of aggregate reports to maintain compliance with regulatory agencies
- Collaborate with cross-functional teams to ensure timely and accurate reporting of safety data.
- Independently author non-safety sections of aggregate reports.
- Synthesize and replicate scientific data analysis
- Develop and implement standard operating procedures for document management and reporting processes while identifying and executing on process improvement opportunities
- Provide training and support to team members on document management systems and processes.
- Utilize project management skills to ensure efficient and compliant execution of reporting activities.
- Maintain up-to-date knowledge of regulatory requirements and industry best practices.
Qualifications
Education : Bachelor's degree in life sciences, healthcare, or related field
Experience :
Strong skills and experience in :
About Alnylam : Alnylam Pharmaceuticals (Nasdaq : ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.
Our culture : Our people-first culture is guided by our core values : fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.
