Clinical Operations and Regulatory Affairs Intern 2022

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.

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.

About us

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 (2019-2021), a Boston Globe Top Places to Work seven years in a row (2015-2021), a Great Place to Work in Asia, Japan, Brazil, the U.K., Germany, Spain, Netherlands, Italy, France and Switzerland, Seramount’s 100 Best Companies (formerly Working Mother 100 Best Companies) and Best Companies for Dads, Bloomberg’s Gender Equality Index two years in a row (2021-2022), among others.  At Alnylam, we are committed to fostering a diverse, equitable and inclusive work environment, culture, and workforce, and we support several Employee Resource Networks.

The intern will work in both Clinical Operations and Regulatory Affairs, alternating between the two Departments (50:50).

Although it is anticipated that the incumbent will primarily support Clinical Operations and Regulatory Affairs, they may also have the opportunity to support activities undertaken by the Medical and Commercial group also located in the UK.

Key Responsibilities – Clinical Operations

• Manage documentation management system, such as: investigator CVs, Food and Drug Administration 1572 forms, informed consent forms, Independent Ethics Committee/ Investigational Review Board materials
• Compile, review, retrieve reports from internal or Contract Research Organization (CRO) electronic document management system
• Create electronic TMF according to International Committee on Harmonization – Good Clinical Practice and internal Standard Operating Procedures, file documents, check for completeness, archived TMFs
• Contact with investigator sites:
  • Send supplies and documents to investigators
  • Create blank department and clinical trial management tools
• Participate in the development, review and editing, of protocol synopses, protocols, and amendments
• Participate in the review of sections and compile appendices of clinical study reports
• Create/update clinical trial study documents for use at the clinical trial study sites towards better subject/patient participation and management in the trial
• Collate and review trial information to be posted on clinicaltrials.gov website
• Review and edit CRO generated trial specific monitoring, safety, data management plans
• Update and track biomarker sample shipping logs with information received from investigator sites and vendors
• Prepare/update slide decks on programs in clinical trial development to be used during various internal and external meeting forums
• Research publications and abstracts relating to siRNA, diseases and or potential drug targets of interest and summarized the information from the researched publications
• Create overviews comparing various elements of ongoing/planned studies for a given compound
• Participate in regular Clinical Operations Department meetings and in weekly 1 on 1 informational sessions (held with Clinical Operations team members) related to strategic clinical drug development, global regulatory affairs issues.
• Participate in clinical trial investigator site visit(s)

Key Responsibilities – Regulatory Affairs

• Work with global regulatory leads (GRLs)/ regulatory product leads (RPLs) and RA management to contribute to global regulatory strategy.
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Regulatory documents may include the relevant forms, meeting requests, Briefing Documents for Health Authority (HA) meetings, Clinical Trial Applications (CTAs) and components of Marketing Authorisation Applications.
• Develop, maintain and track detailed regulatory project plans and support regulatory activities relating to specific products or projects.
• Help coordinate responses to regulatory authorities' questions with strict deadlines.
• Gather regulatory or competitive intelligence to assist with formulating regulatory strategy.
• Serve as a liaison when needed with internal departments at Alnylam, with contract research organisations (CROs), etc.
• Maintain regulatory files in a format consistent with internal requirements
• Facilitate, as necessary, the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance.
• Participate in regular Regulatory Affairs Department meetings.

Supervision / training / professional development

• Role-based training on company processes and procedures will be provided.
• As a research-based organization, all Alnylam personnel have the opportunity to participate in educational training and seminars.

Qualifications

• Studying for a bachelor’s degree in scientific discipline.
• Excellent written and verbal communication skills.
• Strong critical thinking skills.
• Excellent organisational and project management skills; ability to prioritise multiple projects.
• Ability to work in a team environment, possessing interpersonal skills to effectively work with other departments at various levels and with CROs and external consultants.
• Technical system skills (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting.