Digital Project Manager, Patient Safety - Clinical Informatics

Company: Moderna Therapeutics
Location: Cambridge
Posted on: November 22, 2021

Job Description:

(Contract) Digital Project Manager, Patient Safety - Clinical Informatics Moderna is searching for a Digital Project Manager, Patient Safety to oversee and facilitate the execution and to enable the workstreams associated with Moderna's ambitious pharmacovigilance and drug safety digital program. Moderna has initiated a multi-year Pharmacovigilance Digital Transformation program aimed at optimizing and automating the case intake and associated workflows. The program will be broken down in several projects and workstreams that need to evolve independently yet stay interconnected. A pivotal project of this multi-year program is the implementation of an Artificial Intelligence (A.I.) off-the-shelf platform to enable this automation. In this role, the Patient Safety Digital Project Manager (PM) will connect with the workstream lead and ensure progress and delivery match the overall project plan.--This role is highly cross functional, and the incumbent will work across Moderna's ecosystem of services and technology providers to ensure the definition, delivery and operations of patient safety digital solutions. Here's What You'll Do: Facilitate and report across the various workstream of the digital patient safety projects Engage with all workstream leads to support appropriate activities Coordinate and participate in reporting Ensure timelines from the various workstream are followed stablish and manage risks and mitigations Lead various stakeholders from patient safety, digital, validation, and Moderna's preferred vendors Underscore risk and associated migration to report to the Project Management Office of the program Work collaboratively across the workstreams and with preferred vendors to gain alignment on project objectives and deliverables Report on project progress and status--to management and to the program management office for the initiative Here's What You'll Bring to the Table: 8+--years' experience--in digital project management in a--GxP--environment Proven experience in pharmacovigilance systems and processes in an on-shore/off-shore model Working knowledge of Oracle Argus and various safety reporting systems Deep understanding of core pharmacovigilance business processes for case management and reporting Experience in using AI/ML and robotics approaches to safety case processing Good track record in using Agile approaches in a regulated environment First-hand knowledge of SaaS technology in a--GxP--environment and practical understanding of data integrity requirements. You work independently yet engage proactively with team members, colleagues and stakeholders to get alignment and drive projects forward. You can effectively manage conflicting priorities in a fast pace environment, and you can navigate ambiguity and lead a team effectively You put team before tasks--by collaborating actively with all team members and supporting them. Great interpersonal skills and ability to work and lead in a matrixed environment Bachelor's degree in Computer Science, Biotechnology or equivalent required. Master's preferred About Moderna : In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most effective vaccines against the COVID-19 pandemic. Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com . Moderna is a smoke-free, alcohol-free and drug-free work environment. Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.#LI-AJ1 At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies M oderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process.Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

Keywords: Moderna Therapeutics, Cambridge , Digital Project Manager, Patient Safety - Clinical Informatics, Healthcare , Cambridge, Massachusetts