Location: San Diego, Calif. (Hybrid)
Job Type: 3-4 Month Contract
Who We Are
Avenzo Therapeutics, Inc. (“Avenzo”) is an early-stage biotechnology company focused on developing the next generation of 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, 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 Senior Vice President, Regulatory Affairs, the Contractor, Senior Manager/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 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
- Review the work of other writers contributing to the program to ensure information and messaging is consistent across all deliverables and documents are of high quality
- 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, advanced medical or life sciences or a related area degree preferred (e.g., MS, Ph.D.) with 10 years of experience in the pharmaceutical or biotechnology industry or an equivalent combination of academic and industry experience
- 8+ years’ experience in a medical and regulatory writing capacity within drug development
- 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
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders, including senior leaders
- 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
- Some familiarity with statistical analysis concepts and techniques
- 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:
- Hybrid; on-site requirement Monday through Wednesday each week
- 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
A reasonable estimate of the base salary range for this role is $125-175/hr. The final salary offered to a successful candidate will be dependent on several factors such as experience, education, skills and competencies.
Avenzo is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, national origin, ancestry, sex, gender, sex stereotype, gender identity, gender expression, transgender, sexual orientation, pregnancy, childbirth, breastfeeding or related medical condition, religious creed, physical disability, mental disability, age, medical condition, marital status, registered domestic partner status, military or veteran status, genetic information or characteristics, or any other characteristic protected by federal, state or local law. Avenzo also prohibits discrimination, harassment, disrespectful or unprofessional conduct based on the perception that anyone has any of those characteristics or is associated with a person who has or is perceived as having any of those characteristics.
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.