Houston Methodist Academic Institute
Research Informed Consent Editor / Senior Scientific Writer
Houston Methodist Academic Institute, Grapeland, Texas, United States, 75844
At Houston Methodist, the Senior Scientific Writer is responsible for functioning as the mentor for junior staff with an extensive knowledge of both medical and technical science while working with scientific and clinical teams to concisely and clearly communicate technical medicine and science in writing, in accordance with regulations, standards and guidelines. This role must also have familiarity with scientific and clinical research and will conduct comprehensive literature searches for writing and editing abstracts, manuscripts, review articles, grant applications, clinical study protocols, investigator brochures, consent forms, presentations and progress reports for both scientific and lay audiences.Additional Information:Informed Consent Document and Patient-Facing Material Editing
Comprehensive editing and/or authoring of all informed consent documents and patient-facing materials submitted by Houston Methodist investigators. Assures compliance with applicable regulations (45 CFR 46, 21 CFR 50, ICH-GCP), local requirements, and institutional policies. Align the informed consent document with the protocol and applicable ancillary documents. Use of correct grammar and punctuation and adherence to Plain Language and health literacy principles.Subject Matter Expert
Provide guidance and subject matter expertise related to informed consents across the institution, especially in central offices, research departments, and the IRB.
Quality Improvement
Provide education, training, and collaboration as it relates to informed consent amongst central offices and research departments to streamline processes and create efficiencies.PEOPLE ESSENTIAL FUNCTIONSSubject matter expert responsible for research, writing, and editing of technical documents.Mentors and coaches other scientific writers in editing and compiling appendices of documents related to technical reports.Works with departments, agencies and sponsors to ensure that specific requirements are met with respect to document content and formatting.
SERVICE ESSENTIAL FUNCTIONSIndependently creates technical documents (collaborating with the team) based on the strategy provided, and is accountable for the format, content, and adherence to global and electronic publishing standards of the individual submission documents that he/she is the author of.Interprets data and advises faculty as how to best present data considering scientific communications best practices.Works with Principal Investigator(s) to develop, present, and bring to final submission high quality, large, multi-disciplinary, and multi-collaborative grant proposals and publications.
QUALITY/SAFETY ESSENTIAL FUNCTIONSPrepares moderately complex documents and sections of regulatory submissions and contributes scientific knowledge and analytical skills to the preparation of grant proposals, manuscripts, presentations, protocols, and clinical regulatory documentation.Prepares technical documents that adhere to regulatory, financial, policy, and legal requirements.Assures compliance with Houston Methodist policies, rules, and regulations to meet government, publisher, and sponsor standards and research development best practices.
FINANCE ESSENTIAL FUNCTIONSDevelopment of grant application budgets, industry contracts and subcontracts, and other financial documents in compliance with Houston Methodist policies and procedures.Contributes to quality improvement and success of grants applications.
GROWTH/INNOVATION ESSENTIAL FUNCTIONSFinds and implements innovations in scientific writing, grant development and research development to continuously improve best practices.Seeks opportunities to for continual professional development.Fosters a positive and constructive teaching environment by engaging students and co-workers in learning opportunities that are valuable and in alignment with business objectives.
This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.EDUCATIONMaster's Degree requiredPhD Preferred
WORK EXPERIENCESix years' experience in technical or scientific writingTwo years with grant applications preferredLICENSES AND CERTIFICATIONS - REQUIREDN/AKNOWLEDGE, SKILLS, AND ABILITIESDemonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluationsSufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or securityAbility to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principlesAbility to write in a clear, concise, and accurate language that can be understood by technical and non-technical audiencesAbility to understand complex scientific information, theories, and practices.Skilled in identifying extramural funding mechanisms for faculty and programsSkilled in coordinating strategic writing projectsSUPPLEMENTAL REQUIREMENTSWORK ATTIREUniform NoScrubs NoBusiness professional YesOther (department approved) NoON-CALLNote that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.On Call NoTRAVELTravel specifications may vary by departmentMay require travel within the Houston Metropolitan area NoMay require travel outside Houston Metropolitan area YesCompany Profile:Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.Houston Methodist is an equal opportunity employer inclusive of women, minorities, disabled persons and veterans.Equal Employment OpportunityHouston Methodist is an Equal Opportunity Employer.Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor - priority referral Protected Veterans requested.
Comprehensive editing and/or authoring of all informed consent documents and patient-facing materials submitted by Houston Methodist investigators. Assures compliance with applicable regulations (45 CFR 46, 21 CFR 50, ICH-GCP), local requirements, and institutional policies. Align the informed consent document with the protocol and applicable ancillary documents. Use of correct grammar and punctuation and adherence to Plain Language and health literacy principles.Subject Matter Expert
Provide guidance and subject matter expertise related to informed consents across the institution, especially in central offices, research departments, and the IRB.
Quality Improvement
Provide education, training, and collaboration as it relates to informed consent amongst central offices and research departments to streamline processes and create efficiencies.PEOPLE ESSENTIAL FUNCTIONSSubject matter expert responsible for research, writing, and editing of technical documents.Mentors and coaches other scientific writers in editing and compiling appendices of documents related to technical reports.Works with departments, agencies and sponsors to ensure that specific requirements are met with respect to document content and formatting.
SERVICE ESSENTIAL FUNCTIONSIndependently creates technical documents (collaborating with the team) based on the strategy provided, and is accountable for the format, content, and adherence to global and electronic publishing standards of the individual submission documents that he/she is the author of.Interprets data and advises faculty as how to best present data considering scientific communications best practices.Works with Principal Investigator(s) to develop, present, and bring to final submission high quality, large, multi-disciplinary, and multi-collaborative grant proposals and publications.
QUALITY/SAFETY ESSENTIAL FUNCTIONSPrepares moderately complex documents and sections of regulatory submissions and contributes scientific knowledge and analytical skills to the preparation of grant proposals, manuscripts, presentations, protocols, and clinical regulatory documentation.Prepares technical documents that adhere to regulatory, financial, policy, and legal requirements.Assures compliance with Houston Methodist policies, rules, and regulations to meet government, publisher, and sponsor standards and research development best practices.
FINANCE ESSENTIAL FUNCTIONSDevelopment of grant application budgets, industry contracts and subcontracts, and other financial documents in compliance with Houston Methodist policies and procedures.Contributes to quality improvement and success of grants applications.
GROWTH/INNOVATION ESSENTIAL FUNCTIONSFinds and implements innovations in scientific writing, grant development and research development to continuously improve best practices.Seeks opportunities to for continual professional development.Fosters a positive and constructive teaching environment by engaging students and co-workers in learning opportunities that are valuable and in alignment with business objectives.
This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.EDUCATIONMaster's Degree requiredPhD Preferred
WORK EXPERIENCESix years' experience in technical or scientific writingTwo years with grant applications preferredLICENSES AND CERTIFICATIONS - REQUIREDN/AKNOWLEDGE, SKILLS, AND ABILITIESDemonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluationsSufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or securityAbility to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principlesAbility to write in a clear, concise, and accurate language that can be understood by technical and non-technical audiencesAbility to understand complex scientific information, theories, and practices.Skilled in identifying extramural funding mechanisms for faculty and programsSkilled in coordinating strategic writing projectsSUPPLEMENTAL REQUIREMENTSWORK ATTIREUniform NoScrubs NoBusiness professional YesOther (department approved) NoON-CALLNote that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.On Call NoTRAVELTravel specifications may vary by departmentMay require travel within the Houston Metropolitan area NoMay require travel outside Houston Metropolitan area YesCompany Profile:Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.Houston Methodist is an equal opportunity employer inclusive of women, minorities, disabled persons and veterans.Equal Employment OpportunityHouston Methodist is an Equal Opportunity Employer.Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor - priority referral Protected Veterans requested.