This role is considered Hybrid.

Manager, PMS Japan

Overview

Alnylam (Nasdaq: ALNY) is delivering on a bold vision to turn scientific possibility into reality, with a robust RNA interference (RNAi) therapeutics platform. As the pioneer in RNAi and the leading RNAi therapeutics company, we have always been uncompromisingly dedicated to translating the breakthrough science into transformational medicines to help as many people as possible. Long focused on rare and genetic diseases, our scientific advances are now allowing us to bring the power of RNAi therapeutics to more prevalent diseases and as a result, we are beginning to recognize the full potential of this new class of medicines. You can learn more about our pipeline here.

Alnylam is committed to its journey to become a top 5 independent, global biopharma company. We are already admired and recognized for our dedication to patients, company culture that empowers people to do their best work, track record of scientific innovation, social responsibility, and commercial excellence.

Founded in 2002, and headquartered in Cambridge, Mass., Alnylam has over 1,650 employees at work across the globe. We are seeking smart, passionate, “change the world” kind of people who are ready to say, “challenge accepted” to our mission. Thanks to the commitment of every employee globally, Alnylam is proud to have been recognized as one of Fast Company’s 2021 Best Workplaces for Innovators, a Science Magazine Top Employer three years in a row (2019-2020), a Boston Globe Top Places to Work six years in a row (2015-2021), a Great Place to Work in Asia, Brazil, the U.K., and Switzerland, Searmount’s 100 Best Companies and Best Companies for Dads, Bloomberg’s Gender Equality Index, among others.

Manager, PMS Japan is responsible for the management and implementation of post-marketing surveillances and observational studies.

This position reports to the PMS Group Sr. Manager, Japan Patient Safety and Risk Management. The successful candidate is expected to work independently with support from drug safety and colleagues in Global Patient Safety & Risk Management. This individual will communicate and collaborate with Sales, Marketing department experts to optimize departmental compliance and quality.

Summary of Key Responsibilities

• Support the management of all aspects of PMS and observational studies from planning process to re-examination. Activities include management of budget, reports development, and enrolment, timeline projections, document management and archiving.
• Support the Post-Marketing Surveillance Manager (Cyouseki) to lead development and maintenance (i.e., including revision and archiving as necessary) of PMS plans, protocols and related documents based on PMS strategy agreed by all relevant stakeholders (e.g., drug safety, medical affairs, clinical development, and commercial strategy).
• Contribute to the coordinate operational execution of PMS plans including: Site activities from site selection through close out, training of medical representatives and other relevant staff ,Data Management, analysis and reporting
• Conduct and management of Japanese periodical safety reports(J-PSUR) PMS part
• Local contractual management and oversight of CROs and vendors, in alignment with global clinical operations procedures
• Set up PMS team includes external vendors as required, develop/execute team communications.
• Review, implement and maintain GPSP SOPs to enable PMS to be implemented accurately and smoothly and to align with Alnylam’s core values, standards and procedures.
• Develop and implement GPSP training for all relevant internal stakeholders.
• Act as an interface with PMDA in collaboration with drug safety.
• Provide J-NDA support and PV support where required.
• Preparation and responsible for Regulatory Inspection or internal/ external Audit

1. GPSP inspection by PMDA

2. GVP audit by global or other companies

3. GVP inspection by Tokyo Metropolitan Government

Qualifications

• Minimum of B.S. or the equivalent combination of relevant education or professional experience
• Pharmaceutical/biotechnology industry PMS relevant experience
• Specific experience in rare disease at global level is preferred.
• Clinical/ drug safety experience preferred
• Demonstrates expertise related to understanding the PMS requirements in Japan.
• Demonstrates ability to effectively communicate and influence the outcomes of the decision-making process.
• Proven ability to manage projects/teams of scope and complexity, while meeting all deliverables and timelines.
• Maintains a knowledge of current industry trends, standards and methodologies as it relates to PMS.
• Ability to identify PMS issues, initiatives and projects at cross functional meetings.
• Ability to represent the functional department as primary internal and external contact on PMS deliverables in Japan. Negotiation skills encouraging discussion and driving decisions to desired results.

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

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 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.