Job Description
XenoSTART, the preclinical division of START is a translational research organization focused on creating relevant preclinical cancer models. Our xenograft models represent each cancer type and disease stage and are established from patients at our domestic and international cancer centers. The XenoSTART Patient-Derived Xenograft (XPDX) platform includes over 2,500 models annotated with each donor patient’s cancer treatment and outcome data and characterized using IHC, DNA/RNA sequencing, and relevant in vivo drug efficacy.
Our XPDX models are clinically annotated and include patient treatment history and outcome and are characterized through genomic profiling, histologic analysis, and in vivo drug sensitivity to relevant standards of care. These models may be utilized in the following manner:
- In vivo PK/PD and efficacy studies
- In vivo efficacy panel screens (indication or target focused)
- In licensing of models for internal studies
- Custom model development
- Orthotopic and radiotherapy studies
- Ex vivo and organoid studies
We are hiring a Sr. Scientific Writer who is recognized as a contributor and subject matter expert in preparation of regulatory documentation.
Essential Responsibilities - Apply in-depth knowledge of regulatory medical or scientific writing to support pipeline projects.
- Represent functional area in cross-functional team (either internally or externally).
- Produce high-quality and timely documentation in line with internal and client expectations. Interpret and apply knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines.
- Support writing projects including the design, planning, and preparation of study documentation in support of IND submission, (e.g., abbreviated data reports, pivotal study reports), and works collaboratively with colleagues across functions to achieve results.
- Solve complex problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve.
- Oversee the work of other medical writers, providing scientific and operational mentorship and coaching in the design, planning, and execution of their assignments. Provide feedback to their managers on development plans and performance reviews.
- Provide leadership for medical writing processes, standards, and initiatives.
- Provide leadership of and management for complex documentation projects and project teams of medical writers.
- May participate in orientation and coaching of junior team members or contractor writers.
- Participate in or leads initiatives to improve medical writing processes and standards.
Education & Experience - Degree in a life science, preferably related to pharmacy or medicine.
- Bachelor’s degree with 5+ years of experience; Master’s degree with 4+ years of experience; or doctoral-level degree (e.g., PhD, MD, DVM, DO, PharmD) with 3+ years of relevant career experience.
- Ability to prepare, with minimal supervision, a subset of regulatory documents e.g., Study Reports (SR), sections of Investigational New Drug Application (IND)/Investigational Medicinal Product Dossier (IMPD) and Common Technical Document (CTD) according to company guidelines and international governmental regulations, and to present data objectively in a clear, concise format in keeping with industry guidelines.
- Demonstrated participation in medical writing, document, and project teams.
- Technical expertise in typical office Applications (e.g., Microsoft Office, Adobe Acrobat) and in shared document systems (e.g., Google Docs, SharePoint). Familiarity with concepts of structured content management preferred.
- Demonstrated excellent presentation, writing, and project management skills.
Physical and Travel Requirements: - Sitting and working at a computer for prolonged periods of time.
Best-in-Class Benefits and Perks We value our employees’ time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including:
- Comprehensive health coverage: Medical, dental, and vision insurance provided
- Robust retirement planning: 401(k) plan available with employer matching
- Financial security: Life and disability insurance for added protection
- Flexible financial options: Health savings and flexible spending accounts offered
- Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided
- Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.
More about The START Center for Cancer Research Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com .
Ready to be part of a team changing the future of cancer treatment? Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.
We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
XenoSTART, the preclinical division of START is a translational research organization focused on creating relevant preclinical cancer models. Our xenograft models represent each cancer type and disease stage and are established from patients at our domestic and international cancer centers. The XenoSTART Patient-Derived Xenograft (XPDX) platform includes over 2,500 models annotated with each donor patient’s cancer treatment and outcome data and characterized using IHC, DNA/RNA sequencing, and relevant in vivo drug efficacy.
Our XPDX models are clinically annotated and include patient treatment history and outcome and are characterized through genomic profiling, histologic analysis, and in vivo drug sensitivity to relevant standards of care. These models may be utilized in the following manner:
- In vivo PK/PD and efficacy studies
- In vivo efficacy panel screens (indication or target focused)
- In licensing of models for internal studies
- Custom model development
- Orthotopic and radiotherapy studies
- Ex vivo and organoid studies
We are hiring a Sr. Scientific Writer who is recognized as a contributor and subject matter expert in preparation of regulatory documentation.
Essential Responsibilities - Apply in-depth knowledge of regulatory medical or scientific writing to support pipeline projects.
- Represent functional area in cross-functional team (either internally or externally).
- Produce high-quality and timely documentation in line with internal and client expectations. Interpret and apply knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines.
- Support writing projects including the design, planning, and preparation of study documentation in support of IND submission, (e.g., abbreviated data reports, pivotal study reports), and works collaboratively with colleagues across functions to achieve results.
- Solve complex problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve.
- Oversee the work of other medical writers, providing scientific and operational mentorship and coaching in the design, planning, and execution of their assignments. Provide feedback to their managers on development plans and performance reviews.
- Provide leadership for medical writing processes, standards, and initiatives.
- Provide leadership of and management for complex documentation projects and project teams of medical writers.
- May participate in orientation and coaching of junior team members or contractor writers.
- Participate in or leads initiatives to improve medical writing processes and standards.
Education & Experience - Degree in a life science, preferably related to pharmacy or medicine.
- Bachelor’s degree with 5+ years of experience; Master’s degree with 4+ years of experience; or doctoral-level degree (e.g., PhD, MD, DVM, DO, PharmD) with 3+ years of relevant career experience.
- Ability to prepare, with minimal supervision, a subset of regulatory documents e.g., Study Reports (SR), sections of Investigational New Drug Application (IND)/Investigational Medicinal Product Dossier (IMPD) and Common Technical Document (CTD) according to company guidelines and international governmental regulations, and to present data objectively in a clear, concise format in keeping with industry guidelines.
- Demonstrated participation in medical writing, document, and project teams.
- Technical expertise in typical office Applications (e.g., Microsoft Office, Adobe Acrobat) and in shared document systems (e.g., Google Docs, SharePoint). Familiarity with concepts of structured content management preferred.
- Demonstrated excellent presentation, writing, and project management skills.
Physical and Travel Requirements: - Sitting and working at a computer for prolonged periods of time.
Best-in-Class Benefits and Perks We value our employees’ time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including:
- Comprehensive health coverage: Medical, dental, and vision insurance provided
- Robust retirement planning: 401(k) plan available with employer matching
- Financial security: Life and disability insurance for added protection
- Flexible financial options: Health savings and flexible spending accounts offered
- Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided
- Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.
More about The START Center for Cancer Research Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com .
Ready to be part of a team changing the future of cancer treatment? Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.
We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Job Tags
Full time, For contractors, Work experience placement, Local area, Remote job, Worldwide, Flexible hours,