AVENZO THERAPEUTICS INC
The Associate Director, Medical Writing authors, edits, and provides input for regulatory submission documents, presentations, posters, publications, and regulatory fulfillment, with a focus on oncology therapies. The role involves leading medical writing efforts across multiple clinical programs and collaborating with cross-functional teams to ensure clarity, compliance, and strategic positioning of clinical and regulatory documents.
Key Responsibilities
- • Serve as the lead medical writer on multiple clinical programs
- • Coordinate preparation of application packages, including Investigational New Drug (IND) applications including life cycle management, Clinical Trial Applications (Ex-US), and New Drug Applications (NDAs)
- • Develop, align, coordinate, and build consistent information and messages across regulatory documents within a global clinical program
- • Ensure all documents across programs are planned, developed, managed, reviewed, quality checked, and approved according to mutually agreed timelines with input from all critical stakeholders
- • Collaborate with cross functional teams on the development and/or revision of protocols, protocol amendments, clinical study reports, clinical sections of regulatory submission documents, investigator’s brochures, annual reports, publications (manuscripts, abstracts, poster presentations, etc.), and other documents as needed
- • Ensure that the content of each document is clear, concise, strategic, well-positioned for public disclosure, meets scientific standards and complies with regulatory guidelines
- • Assist in developing and maintaining SOPs
- • Provide guidance on medical writing templates, QC Procedures, SOPs, and processes within and across departments
- • Take the initiative to solve problems, exercising sound judgment and appropriate flexibility within a dynamic environment
- • Other duties as assigned
Required
- • Bachelor’s degree required, PhD in advanced medical or life sciences or a related area degree preferred (e.g., MS, Ph.D.) with 8+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience
- • Extensive recent hands-on oncology experience, preferably within targeted oncology programs
- • Demonstrated, recent hands-on experience authoring regulatory designation submissions from inception, including Orphan Drug, Fast Track and Breakthrough Therapy applications
- • Proven experience preparing US and global health authority documents from scratch including meeting requests, briefing books and responses to regulatory requests for information
- • Thorough knowledge of clinical research concepts, practices, and Food and Drug Administration (FDA)/European Medicines Agency (EMA) regulations and International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH)/Good Clinical Practices (GCPs) Guidelines regarding drug development phases, clinical research, and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
- • Awareness of regulations pertaining to clinical trial disclosure and data sharing
- • Experience with relationship management and oversight of medical writing activities carried out by CROs and vendors
- • Exceptional ability to communicate highly complex ideas
- • Expert in facilitating discussions to bring cross functional teams into alignment regarding the content of clinical documents
- • Experience communicating timeline expectations with cross-functional study team members
- • Experience with electronic document management systems
- • Highly proficient in the functionality of MS Word, Excel, Adobe Acrobat, and PowerPoint
- • Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
- • Strong analytical and problem-solving abilities, with a strategic mindset
Benefits & Perks
- • Group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance
- • Short-term and long-term disability insurance
- • Flexible spending accounts
- • Health savings account
- • Voluntary insurance programs including voluntary life and AD&D accident, and critical illness
- • 401(k) plan
- • 10 hours of paid vacation time every month
- • Accrue 1 hour of paid sick leave for every 30 hours worked
- • 17 paid holidays, including a winter closure
- • Up to 8 weeks of paid parental and/or medical leave
- • Annual discretionary bonus based on achievement of certain metrics of up to 20% of annual base salary
- • Equity grant in the form of a direct grant of stock options
Company Overview
Industry: Healthcare Technology
Company Size: 500-1,000 employees
Founded: 2015
Headquarters: San Francisco, CA
Company Links
Key Contacts
Contact information not available
About the Company
Leading healthcare technology company focused on improving patient outcomes through innovative digital solutions. We're transforming the way healthcare is delivered with cutting-edge technology and data-driven insights. Our platform serves over 10,000 healthcare professionals and has processed millions of patient interactions.
Recent News & Updates
Job Title: Associate Director, Medical Writing
Location: San Diego, California
Job Type: Full-Time
Who We Are
Avenzo Therapeutics, Inc. (“Avenzo”) is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. The company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics, Inc. respectively). With a proven track record in building and scaling biotech companies, our experienced management team is passionate about and committed to building a pipeline of potential best-in-class targeted oncology programs. The company is headquartered in San Diego, California.
Position Summary
Reporting to the Director, Medical Writing, the Associate Director, Medical Writing will author, edit and provide input to documents required for regulatory submissions to US and other global health authorities, presentations, posters, publications and regulatory fulfillment. They may also author, edit and direct the development of pre-clinical documents. The candidate will ideally have a background in drugs and biologics. Experienced, independent medical writers who have worked with cross-functional program teams and want to be part of the next generation of cancer therapies at a growing company should apply.
Essential Job Functions and Responsibilities
- Serve as the lead medical writer on multiple clinical programs
- Coordinate preparation of application packages, including Investigational New Drug (IND) applications including life cycle management, Clinical Trial Applications (Ex-US), and New Drug Applications (NDAs)
- Develop, align, coordinate, and build consistent information and messages across regulatory documents within a global clinical program
- Ensure all documents across programs are planned, developed, managed, reviewed, quality checked, and approved according to mutually agreed timelines with input from all critical stakeholders
- Collaborate with cross functional teams on the development and/or revision of protocols, protocol amendments, clinical study reports, clinical sections of regulatory submission documents, investigator’s brochures, annual reports, publications (manuscripts, abstracts, poster presentations, etc.), and other documents as needed
- Ensure that the content of each document is clear, concise, strategic, well-positioned for public disclosure, meets scientific standards and complies with regulatory guidelines
- Assist in developing and maintaining SOPs
- Provide guidance on medical writing templates, QC Procedures, SOPs, and processes within and across departments
- Take the initiative to solve problems, exercising sound judgment and appropriate flexibility within a dynamic environment
- Other duties as assigned
Qualifications
- Bachelor’s degree required, PhD in advanced medical or life sciences or a related area degree preferred (e.g., MS, Ph.D.) with 8+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience
- Extensive recent hands-on oncology experience, preferably within targeted oncology programs
- Demonstrated, recent hands-on experience authoring regulatory designation submissions from inception, including Orphan Drug, Fast Track and Breakthrough Therapy applications
- Proven experience preparing US and global health authority documents from scratch including meeting requests, briefing books and responses to regulatory requests for information
- Thorough knowledge of clinical research concepts, practices, and Food and Drug Administration (FDA)/European Medicines Agency (EMA)regulations and International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH)/Good Clinical Practices (GCPs) Guidelines regarding drug development phases, clinical research, and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
- Awareness of regulations pertaining to clinical trial disclosure and data sharing
- Experience with relationship management and oversight of medical writing activities carried out by CROs and vendors
- Exceptional ability to communicate highly complex ideas
- Expert in facilitating discussions to bring cross functional teams into alignment regarding the content of clinical documents
- Experience communicating timeline expectations with cross-functional study team members
- Experience with electronic document management systems
- Highly proficient in the functionality of MS Word, Excel, Adobe Acrobat, and PowerPoint
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
- Strong analytical and problem-solving abilities, with a strategic mindset
Physical Demands and Work Environment
Physical Demands:
- Constant or continuous use of a computer keyboard, monitor and mouse to perform a variety of tasks
- Constant or frequent sitting, standing or walking
- May lift and/or move objects of various weights
Work Environment:
- On-site requirement (Monday through Thursday)
- Noise level in the work environment is usually moderate
- Fast-paced, time sensitive environment with frequently changing priorities
- Handle multiple projects simultaneously
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Anticipated Base Salary Range
The anticipated salary range for candidates is $182,800 to $195,100 per year. The final pay offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and years of experience within the job and the industry, education, and skills and certifications.
Anticipated Benefits
Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance. Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings account, and voluntary insurance programs including voluntary life and AD&D accident, and critical illness. Employees also will be able to enroll in our company’s 401(k) plan. Employees will also receive 10 hours of paid vacation time every month, and accrue 1 hour of paid sick leave for every 30 hours worked. Employees will also enjoy 17 paid holidays, including a winter closure, throughout the calendar year, subject to relevant terms outlined in the employee handbook. Regular, full-time employees are eligible for up to 8 weeks of paid parental and/or medical leave. Eligibility requirements for these benefits will be controlled by applicable plan documents.
Anticipated Other Compensation
Hired applicant will be eligible for an annual discretionary bonus based on achievement of certain metrics of up to 20% of annual base salary. Hired applicant will also receive an equity grant in the form of a direct grant of stock options that will be specified in the employment contract, all subject to the relevant plan documents.
The information above is intended to provide a general description of benefits and other compensation and is not a substitute for applicable plan documents or company policies.
Equal Employment Employer
Avenzo is committed to providing equal employment opportunities to all employees and applicants without regard to an individual’s actual or perceived protected characteristic or characteristics, or any combination of protected characteristics including race (including traits associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniformed service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), the employee or their family member’s status as a victim of a qualifying act of violence, political activity or affiliation, use of cannabis off the job and away from the workplace, association with an individual who has, or is perceived to have, a protected characteristic or characteristics, or any combination of protected characteristics, or any other protected status in accordance with all applicable federal, state, and local laws.
Notice to Search Firms/Third Party Agencies
Avenzo does not accept unsolicited resumes from recruiters or employment agencies without an executed search agreement in place.
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