Senior Manager/Associate Director, Medical Writing
Description:
About BridgeBio Oncology Therapeutics
BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit BBOTx.com.
The Senior Manager/Associate Director, Medical Writer is responsible for the medical writing deliverables that support the clinical portfolio at BBOT. The Senior Manager/Associate Director will prepare clinical study documents (clinical study protocols/amendments, clinical study reports, investigator’s brochure) and clinical sections of regulatory submissions. As a vital member of the BBOT Team, the Medical Writer will have the opportunity to collaborate cross-functionally and ensure key messages are consistently aligned in preparing the clinical regulatory document.
Responsibilities
• Participate in strategic discussions regarding the production and completion of high-quality clinical documents, including providing input on workload allocation, resource planning, and timeline development, as applicable.
• Participate in the development and implementation of process improvements and/or standards within the Medical Writing function.
• Work closely with cross-functional teams to ensure high-quality documents are completed in a timely fashion, compliant with SOPs, and consistent with industry standards, ICH/GCP guidance, and all applicable regulatory requirements.
• Collaborate with internal and external resources to ensure alignment with timelines and data communication plans.
• Ensure smooth and effective document management for clinical regulatory documents.
• Author or provide support for clinical documents and other assigned tasks within established timelines.
• Distill large amounts of clinical and scientific data into essential elements for graphical display.
• Maintain high document quality and appropriate standards for scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
• Review, edit, and ensure the quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required, and ensure adherence to standards.
• Formulate critical messages from clinical study data with the study team(s).
• Prepare content library for study protocols on one or more program.
• Represent Medical Writing on one or more programs.
• Liaise with other critical stakeholders as necessary to ensure appropriate coordination of activities.
• Perform other duties as requested.
Requirements:
Education and Qualifications
• Bachelor’s degree in a life sciences discipline; an advanced degree is Preferred.
• Minimum of 7 years of experience working in the biopharmaceutical industry, with a minimum of 5 years in medical writing or equivalent (experience in oncology desired).
• Ability to exercise discretion and show good judgment, demonstrate honesty and integrity, and foster and encourage trust-building behaviors.
• Strong project management and time management skills, along with initiative and ability to be productive with minimal supervision.
• Skilled in the development of clinical regulatory documents, including protocols, amendments, investigator’s brochures, clinical study reports.
• Strong organizational skills; experience and comfort working in a fast paced, dynamic environment.
• Able to work autonomously and in team settings to meet aggressive goals.
• Knowledge of IND/NDA/BLA/MAA submission requirements and familiarity with the eCTD structure is desired.
• A strong understanding of FDA/ICH guidelines and GCP is required.
• Strong technological abilities, with proficiency in Microsoft Word, Excel, and PowerPoint; and strong command of routinely used business software/platforms (e.g., Microsoft Office, Adobe Acrobat, Microsoft SharePoint, Microsoft Visio, Veeva RIM, EndNote, Transcelerate) is required.
• Strong written and verbal communication skills, including fluency in English (oral and written), are required.
Salary
The annual salary range for this position is $171,000 - $210,000 in the San Francisco Bay Area. BBOT considers a variety of factors when determining base compensation, including experience, skills, education, qualifications, and geographic location. Actual compensation will vary, and it is not typical to be hired at or near the top of the range for the role.
Base compensation is part of a robust total rewards offering at BBOT. Additional total rewards elements include annual bonus, stock-based long-term incentives, medical, dental, and vision benefits, retirement, wellness stipend, and flexible time off.
Apply Now
Apply Now
About BridgeBio Oncology Therapeutics
BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit BBOTx.com.
The Senior Manager/Associate Director, Medical Writer is responsible for the medical writing deliverables that support the clinical portfolio at BBOT. The Senior Manager/Associate Director will prepare clinical study documents (clinical study protocols/amendments, clinical study reports, investigator’s brochure) and clinical sections of regulatory submissions. As a vital member of the BBOT Team, the Medical Writer will have the opportunity to collaborate cross-functionally and ensure key messages are consistently aligned in preparing the clinical regulatory document.
Responsibilities
• Participate in strategic discussions regarding the production and completion of high-quality clinical documents, including providing input on workload allocation, resource planning, and timeline development, as applicable.
• Participate in the development and implementation of process improvements and/or standards within the Medical Writing function.
• Work closely with cross-functional teams to ensure high-quality documents are completed in a timely fashion, compliant with SOPs, and consistent with industry standards, ICH/GCP guidance, and all applicable regulatory requirements.
• Collaborate with internal and external resources to ensure alignment with timelines and data communication plans.
• Ensure smooth and effective document management for clinical regulatory documents.
• Author or provide support for clinical documents and other assigned tasks within established timelines.
• Distill large amounts of clinical and scientific data into essential elements for graphical display.
• Maintain high document quality and appropriate standards for scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
• Review, edit, and ensure the quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required, and ensure adherence to standards.
• Formulate critical messages from clinical study data with the study team(s).
• Prepare content library for study protocols on one or more program.
• Represent Medical Writing on one or more programs.
• Liaise with other critical stakeholders as necessary to ensure appropriate coordination of activities.
• Perform other duties as requested.
Requirements:
Education and Qualifications
• Bachelor’s degree in a life sciences discipline; an advanced degree is Preferred.
• Minimum of 7 years of experience working in the biopharmaceutical industry, with a minimum of 5 years in medical writing or equivalent (experience in oncology desired).
• Ability to exercise discretion and show good judgment, demonstrate honesty and integrity, and foster and encourage trust-building behaviors.
• Strong project management and time management skills, along with initiative and ability to be productive with minimal supervision.
• Skilled in the development of clinical regulatory documents, including protocols, amendments, investigator’s brochures, clinical study reports.
• Strong organizational skills; experience and comfort working in a fast paced, dynamic environment.
• Able to work autonomously and in team settings to meet aggressive goals.
• Knowledge of IND/NDA/BLA/MAA submission requirements and familiarity with the eCTD structure is desired.
• A strong understanding of FDA/ICH guidelines and GCP is required.
• Strong technological abilities, with proficiency in Microsoft Word, Excel, and PowerPoint; and strong command of routinely used business software/platforms (e.g., Microsoft Office, Adobe Acrobat, Microsoft SharePoint, Microsoft Visio, Veeva RIM, EndNote, Transcelerate) is required.
• Strong written and verbal communication skills, including fluency in English (oral and written), are required.
Salary
The annual salary range for this position is $171,000 - $210,000 in the San Francisco Bay Area. BBOT considers a variety of factors when determining base compensation, including experience, skills, education, qualifications, and geographic location. Actual compensation will vary, and it is not typical to be hired at or near the top of the range for the role.
Base compensation is part of a robust total rewards offering at BBOT. Additional total rewards elements include annual bonus, stock-based long-term incentives, medical, dental, and vision benefits, retirement, wellness stipend, and flexible time off.
Apply Now
Apply Now