Imaging Endpoints
Website:
imagingendpoints.com
Job details:
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.
Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.
The Medical and Scientific Affairs (Medical/Senior) Writer is primarily responsible for providing medical writing services at a clinical trial level. The Medical and Scientific Affairs Writer may interact with external clients, internal team members, Key Opinion Leaders (KOLs), and Physician Consultant/Contracted reviewers regarding the development of required clinical trial documents. The Medical and Scientific Affairs Writer will be expected to support delivery of IE’s central reader training with regards to study procedures and protocol criteria; and ensuring adherence to Protocol requirements and quality management practices, as applicable.
MEDICAL WRITER, MEDICAL AND SCIENTIFIC AFFAIRS
RESPONSIBILITIES
- Execute medical/scientific project deliverables for imaging studies in clinical trials in accordance with project scope of work and within sponsor specified timelines including but not limited to
- Image Review Charters (and all associated documents)
- Imaging Manuals
- Central Reader Rules (and other reader training material)
- Interim and Final Study Reports, as applicable
- Central reading/image analysis platform design/specifications
- Assist in business development and proposal activities as required
- Provide written medical/scientific input into the following as necessary/applicable
- Study Protocols
- Clinical Case Report Forms
- Imaging component of regulatory submissions
- Assessment Criteria guidelines
- Support training to Radiologists, Oncologists and other sub-specialty Physicians on
- Project-specific Image Review Charter/Reader Rules
- Image analysis platform
- Protocol-specific assessment criteria
- Collaborate with project internal teams to support Sponsor-specified project scope of work as required
- Perform other duties as assigned by the supervisor
EDUCATION AND EXPERIENCE
- Education: Bachelor’s degree desired
- Minimum of 1 year of medial writing experience in imaging core lab or equivalent experience in clinical research, medical imaging, pharmaceutical or medical device industry
SENIOR MEDICAL WRITER, MEDICAL AND SCIENTIFIC AFFAIRS
RESPONSIBILITIES
- Execute medical/scientific project deliverables for imaging studies in clinical trials in accordance with project scope of work and within sponsor specified timelines including but not limited to
- Image Review Charters (and all associated documents)
- Imaging Manuals
- Central Reader Rules (and other reader training material)
- Interim and Final Study Reports, as applicable
- Central reading/image analysis platform design/specifications
- Assist in business development and proposal activities as required
- Provide written medical/scientific input into the following as necessary/applicable
- Study Protocols
- Clinical Case Report Forms
- Imaging component of regulatory submissions
- Assessment Criteria guidelines
- Support training to Radiologists, Oncologists and other sub-specialty Physicians on
- Project-specific Image Review Charter/Reader Rules
- Image analysis platform
- Protocol-specific assessment criteria
- Collaborate with project internal teams to support Sponsor-specified project scope of work as required
- Provide Medical Writers with appropriate coaching, mentoring, and development
- Perform other duties as assigned by the supervisor
EDUCATION AND EXPERIENCE
- Education: Bachelor’s degree desired
- Minimum of 3 years of medial writing experience in imaging core lab or equivalent experience in clinical research, medical imaging, pharmaceutical or medical device industry
SKILLS
- Proficiency in MS office and internet applications
- Must have superior attention to detail and excellent oral and written communication skills
- Ability to manage project activities with diverse groups and individuals
- Must have the ability to multitask and work under pressure
- Must have strong time management and organizational skills. Prioritizing workload to the changing needs of the day-to-day business is also a critical skill
- Hands-on ability to think tactically and strategically
- Service oriented approach, flexible, and proactive towards adapting to clients’ needs
- Must have superior attention to detail and excellent oral and written communication skills
- Self-driven, ability to get the job done with little supervision, can-do positive attitude
- Ability to excel in a team-oriented, fast paced environment
- Ability to work in strict compliance with all procedures, rules, and regulations
- Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
- Must be self-motivated and able to grasp new concepts quickly
IMAGING ENDPOINTS’ TEAM CHARACTERISTICS
- Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging
- Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
- Commitment and caring for our fellow team members, their families, and the communities IE serves - see more information about Caring Endpoints at https://caringendpoints.org/
- Integrity and high ethical standards; we always do the right thing
- High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
- Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE
- Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
- High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else
PHYSICAL REQUIREMENTS
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.
Travel: 5-10% travel (Domestic and International)
Click on Apply to know more.