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Scientist, Clinical Research
This position has a key role to assist the global clinical development, regulatory, and safety to continually assess and analyze clinical safety signal data and inform key stakeholders to implement strategies to minimize risk and proactively partner with global health authorities. This position includes interactions with all areas within clinical development, medical affairs, independent review committees, and regulatory authorities to ensure timely identification, reporting, and response to health authorities with regards to safety issues.
*Please do not submit MDs and PhDs to this position.
Responsibilities will include, but are not limited to, the following:
Assist the Clinical Research Teams in the development and analysis of safety data trends and events of special interest.
Monitor SPM events for assigned programs, participate in reconciliation and preparation for Safety Management Committee reviews.
Support submission teams with safety section development and review.
Prepare or assist with preparation of regulatory authorities documents for SPM and other safety inquires.
Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc.
Review literature and prepare summary documents for inclusion in protocol, IB, health authority communications, regulatory submission documents, etc.
Protocol, CRF, and ICF development and/or review of SPM sections for assigned programs or compounds.
Assist with clinical study report preparation and finalization.
In collaboration with the therapeutic area leads/translational medicine, actively participate in the planning and implementation of clinical studies to meet regulatory and clinical research goals
Provide educational support and expertise to the Clinical Teams relating to SPM and other risk management strategies
Provide review of ongoing safety summary data including: SPM, AE of special interest, and laboratory data.
Participate in adhoc meetings as required by business needs.
Assist V.P./Senior Director/Director Global Clinical Projects on special projects as required
Lead SPM/safety reconciliation team meetings as required
Ability to drive execution
Functions within a global mindset
Promote global cross-functional collaboration and cooperation.
Minimum 2 yrs. experience in medical or technical writing
Clinical monitoring experience preferred
Detail oriented, well organized
Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization as well as external opinion leaders and authorities
Extensive medical/scientific and clinical research knowledge
Knowledge of Medical Terminology
Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics
proficient at data review and interpretation
Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
Experience in all aspects of the drug development process
Knowledge of GCP and ICH Guidelines
Experience in presenting to internal and external audiences
Limited travel required
Ability to assimilate technical and scientific information quickly
Clinical project management skills
Proficient in Microsoft Word, Excel, PowerPoint; EDC databases, SAS datasets
Demonstrated ability to work as part of a global cross functional team
High level of interpersonal and communication skills (written and verbal)
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