Principal Principal Harm Reduction

Principal Principal Harm Reduction (M/F/d)-230005GT

**Applicants are required to read, write, and speak the following languages***: English

**Preferred Qualifications**

Oracle Life Sciences is a leader in cloud technology, pharmaceutical research, and consulting, trusted globally by professionals in both large and emerging companies engaged in clinical research and pharmacovigilance, throughout the therapeutic development lifecycle, including pre
- and post-drug launch activities. With more than 20 years’ experience, Oracle Life Sciences is committed to supporting clinical development and leveraging real-world evidence to deliver innovation and accelerate advancements - empowering the Life Sciences industry to help improve patient outcomes.
- With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Oracle Life Sciences immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.
- The SME Principal in the Clinical RWE domain develops strong, trusted relationships with clients to provide value added input that will lead to additional opportunities built around robust science and strategic issues. They have responsibility for ensuring project delivery with high client satisfaction. This role is specifically focused in harm reduction studies but may also need to lead other Clinical RWE engagements.
- Primary responsibility is to advise and support new opportunity discussions, capabilities, proposals, and projects:
- Provides consulting to study planning, conception, design / methodologies and conduction
- Deliver high-quality proposals
- Review, provide assessment and input to RFIs
- Development and maintenance of domain collateral including capability presentations, proposal templates, case studies and a publication library
- Develop conference strategy, attend or encourage/coordinate attendance and publications/presentations at congresses and conferences
- Work with marketing on developing ideas for thought leadership
- Proactive development and maintenance of harm reduction client relationships

Build the credibility of team by:

- Provide guidance and oversight on projects serving as an advisor to the team and the client
- Collaborate with team leaders for the building and performance of a client focused team inclusive of recruitment process of new team members, ongoing training (formal or informal), and career development for team members regardless of reporting structure
- Coordinate and contribute to, if not lead, training within the team and across the organization
- Consulting with Oracle operational units in assessment and implementation of innovative technology and new methodologies considering client perspective, study objectives, regulatory requirements and internal processes

To succeed, you will need:

- Bachelor’s degree (or equivalent) the field of Life Sciences, Social Sciences, Public Health or a related field is required. At least 15 years of research and consultancy experience in the Life Sciences field.
- Demonstrated ability to manage workflow and communication with clients is a “must.”
- Very strong project management and proven ability to plan and prioritize work to meet commitments and identify, secure, and employ resources needed to achieve results.
- Thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods

**Basic Qualifications**
- At least 10 years total combined related work experience and completed higher education, including:

- At least 3 years licensed health care practice, clinical research, epidemiology and/or biostatistics work experience
- At least 7 years additional work experience directly related to the duties of the job and/or completed higher education
- High School Diploma

**Preferred Qualifications**
- Bachelor's degree or equivalent relevant work experience

**Expectations**
- Perform other responsibilities as assigned
- Willing to work additional or irregular hours as needed and allowed by local regulations
- Work in accordance with corporate and organizational security policies and procedures, understand personal role in safeguarding corporate and client assets, and take appropriate action to prevent and report any compromises of security within scope of position
- At Oracle, we don’t just respect differences—we celebrate them. We believe that innovation starts with inclusion and to create the future we need people with diverse backgrounds, perspectives, and abilities. That’s why we’re committed to creating a workplace where all kinds of people can do their best work. It’s when everyone’s voice is heard and va