Senior Manager/Associate Director, Medical Writing

BBOT; United States; On-site; USD 155,000 - 170,000; Full time

Job summary

A clinical-stage biopharmaceutical company is seeking a Senior Manager/Associate Director for Medical Writing. This role involves preparing pivotal clinical documents, ensuring compliance with regulatory standards, and collaborating across teams to produce high-quality deliverables that support the clinical portfolio.

Qualifications

• Minimum of 7 years of experience in the biopharmaceutical industry.
• 5 years in medical writing or equivalent experience (oncology desired).
• Knowledge of FDA/ICH guidelines and regulatory submissions.

Responsibilities

• Prepare clinical documents such as protocols and reports.
• Ensure compliance with industry standards and regulations.
• Collaborate with internal and external teams for document quality.

Skills

Project Management

Time Management

Document Quality Maintenance

Scientific Writing

Communication Skills

Education

Bachelor’s degree in a life sciences discipline

Advanced degree in a related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Adobe Acrobat

Veeva RIM

Job description

Senior Manager/Associate Director, Medical Writing

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Description

Job Type

Full-time

Description

BBOT is a clinical-stage biopharmaceutical company with a team of researchers working to develop novel therapeutics to address dire unmet needs in oncology. Led by top scientists with extensive track records in drug development, like Frank McCormick and Eli Wallace, our team utilizes structure-based drug discovery techniques to target some of oncology’s most challenging and validated molecular targets, including KRAS and PI3Ka. We are focused and committed to patients, scientific excellence, and operational agility, and we understand that every minute counts in our efforts to develop new therapies to transform the lives of people living with cancer. Our main oncology laboratory is located in South San Francisco, though our research collaborators span the country and globe. To learn more, visit us at https://bridgebio.com/bridgebiooncology.

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

• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

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