Senior Manager, Medical Review
3 weeks ago
The Senior Manager, Medical Review will be an integral part of a growing Medical Affairs organization. The successful candidate will serve as medical reviewer and approver for company-developed US and Global materials for assigned therapeutic areas. This role will collaborate with Regulatory and Legal reviewers and represent the position of Medical Affairs in providing medical expertise and guidance during concept and material review.
The Medical Review team is one of three expertise areas within Medical Information and Review and will work alongside the Medical Information Content Development and the Medical Information Operations teams to support overall team goals and objectives. This role will ensure adherence to US and Global regulations and prevailing industry standards as it pertains to the dissemination of medical information for Alnylam's products and for the review and approval of medical and promotional materials.
Key Responsibilities:
- Provide internal medical review and approval for company-developed US and Global medical and promotional materials for assigned therapeutic areas
- Apply expert clinical and technical product knowledge to ensure all materials developed for internal and external use are scientifically accurate and balanced, supported by the literature, and aligned with medical strategy
- Develop strong cross-functional relationships with key expertise areas such as Medical Affairs, Regulatory, Legal, Commercial, and Compliance
- Participate in key meetings (e.g. medical and program meetings) and business initiatives as needed for assigned therapeutic area(s) and share medical knowledge and expertise
- Oversee vendor support for medical quality control as needed
- Ensure activities are carried out in a compliant and timely manner
- Support Medical Information activities at various scientific congresses as needed (e.g. booth coverage, congress reports, etc.)
- Understanding of broad concepts within Medical Affairs and potential implications across the organization
- Working knowledge of US regulatory guidelines for product promotion
- Critical evaluation of medical literature and high level of attention to detail
- Strong strategic, problem-solving, risk mitigation, and conflict management skills
- Ability to effectively manage time while balancing multiple projects with appropriate prioritization
- Demonstrated strong verbal, written, and presentation skills
- Ability to drive process improvements and innovations based on key learnings
- Advanced scientific degree (PharmD, MD, or PhD) with at least 4-6 years of relevant industry experience in Medical Affairs
- Experience in performing medical review required
- Experience in rare diseases 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.
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Senior Manager, Medical Review
3 weeks ago
Cambridge, United States Alnylam Full timeThe Senior Manager, Medical Review will be an integral part of a growing Medical Affairs organization. The successful candidate will serve as medical reviewer and approver for company-developed US and Global materials for assigned therapeutic areas. This role will collaborate with Regulatory and Legal reviewers and represent the position of Medical Affairs...
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