Sr Manager, Aggregate Report Document Management

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:

• A minimum of five years of relevant work experience in safety/pharmacovigilance, or the equivalent combination of education and experience
• A minimum of 2 years of experience in aggregate report generation or document management (drug safety/pharmacovigilance) in the pharmaceutical industry is preferred
• Strong project management skills with the ability to manage multiple priorities and deadlines.
• Strong analytic and scientific writing abilities
• Quality control experience with document management and ability to improve processes for quality control
• Highly proficient in relevant document management systems and software applications. (VEEVA experience preferred).
• Specific experience in RNA therapeutic area at a global level is an advantage.
• Excellent written and verbal communication skills.
• Attention to detail and commitment to quality and compliance.
• Ability to work collaboratively in a team environment
• Ability to work in the fast-paced environment

Strong skills and experience in:

• Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
• Knowledge of Signaling tools (e.g. Empirica) is preferred
• Regulatory Inspection readiness experience is a plusMedical (scientific) authoring is preferred. 

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.