BridgeBio Pharma
Senior Manager or Associate Director, Medical Writing South San Francisco, Calif
BridgeBio Pharma, South San Francisco, California, us, 94083
Senior Manager or Associate Director, Medical Writing BridgeBio Oncology, South San Francisco, California, United States
Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.BridgeBio Oncology Therapeutics (“BBOT”)
is a clinical-stage biopharmaceutical company focused on developing novel therapeutics to address unmet needs in oncology. Our team, led by top scientists with extensive drug development experience, utilizes structure-based drug discovery techniques to target challenging molecular targets, including KRAS and PI3Kα. We are committed to patients, scientific excellence, and operational agility, understanding that every minute counts in our efforts to develop new therapies to transform the lives of people living with cancer.The Senior Manager/Associate Director is responsible for the medical writing deliverables that support the clinical portfolio at BridgeBio Oncology Therapeutics. This role involves preparing clinical study documents and clinical sections of regulatory submissions. As a vital member of the BBOT Team, the Senior Manager/Associate Director will collaborate cross-functionally to ensure key messages are consistently aligned in preparing clinical regulatory documents.ResponsibilitiesParticipate in strategic discussions regarding the production and completion of high-quality clinical documents.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.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.Review, edit, and ensure the quality of documents prepared by other writers or functional area representatives.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.Education, Experience & Skills RequirementsBachelor’s degree in a life sciences discipline; an advanced degree is preferred.Minimum of 7 years in the biopharmaceutical industry, with at least 5 years in medical writing or equivalent (experience in oncology desired).Ability to exercise discretion and show good judgment, demonstrate honesty and integrity, and encourage trust-building behaviors.Strong project management and time management skills, with the ability to be productive with minimal supervision.Skilled in the development of clinical regulatory documents, including protocols, amendments, investigator’s brochures, and clinical study reports.Strong organizational skills; experience 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.Proficiency in Microsoft Word, Excel, and PowerPoint; and strong command of business software/platforms is required.Strong written and verbal communication skills, including fluency in English (oral and written), are required.What We Offer
A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak.A place where you own the vision – both for your program and your own career path.A collaborative, fast-paced, data-driven environment that inspires top performance.Robust and market-competitive compensation & benefits package.Flexible PTO.Rapid career advancement for strong performers.Commitment to Diversity, Equity & Inclusion.
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Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.BridgeBio Oncology Therapeutics (“BBOT”)
is a clinical-stage biopharmaceutical company focused on developing novel therapeutics to address unmet needs in oncology. Our team, led by top scientists with extensive drug development experience, utilizes structure-based drug discovery techniques to target challenging molecular targets, including KRAS and PI3Kα. We are committed to patients, scientific excellence, and operational agility, understanding that every minute counts in our efforts to develop new therapies to transform the lives of people living with cancer.The Senior Manager/Associate Director is responsible for the medical writing deliverables that support the clinical portfolio at BridgeBio Oncology Therapeutics. This role involves preparing clinical study documents and clinical sections of regulatory submissions. As a vital member of the BBOT Team, the Senior Manager/Associate Director will collaborate cross-functionally to ensure key messages are consistently aligned in preparing clinical regulatory documents.ResponsibilitiesParticipate in strategic discussions regarding the production and completion of high-quality clinical documents.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.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.Review, edit, and ensure the quality of documents prepared by other writers or functional area representatives.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.Education, Experience & Skills RequirementsBachelor’s degree in a life sciences discipline; an advanced degree is preferred.Minimum of 7 years in the biopharmaceutical industry, with at least 5 years in medical writing or equivalent (experience in oncology desired).Ability to exercise discretion and show good judgment, demonstrate honesty and integrity, and encourage trust-building behaviors.Strong project management and time management skills, with the ability to be productive with minimal supervision.Skilled in the development of clinical regulatory documents, including protocols, amendments, investigator’s brochures, and clinical study reports.Strong organizational skills; experience 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.Proficiency in Microsoft Word, Excel, and PowerPoint; and strong command of business software/platforms is required.Strong written and verbal communication skills, including fluency in English (oral and written), are required.What We Offer
A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak.A place where you own the vision – both for your program and your own career path.A collaborative, fast-paced, data-driven environment that inspires top performance.Robust and market-competitive compensation & benefits package.Flexible PTO.Rapid career advancement for strong performers.Commitment to Diversity, Equity & Inclusion.
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