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SalaryUmoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington, and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development. We are committed to the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.
We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.
Umoja Biopharma – Your Body. Your Hope. Your Cure.
POSITION SUMMARY
Umoja is looking for an experienced Medical Writer to oversee the planning, development, coordinating cross-functional subject matter experts and execution of high quality, regulatory-compliant clinical documents as well as support regulatory submissions to the FDA and other agencies. The Medical Writer will also support other clinical communication efforts including abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals.
The ideal candidate will lead all medical writing activities across Umoja's programs, build the medical writing function, be responsible for timely and accurate medical writing deliverables and effectively collaborate with cross-functional teams. The candidate will ideally have a background in biologics and/or cellular/genetic therapies. Experienced, independent Medical Writers who have worked with cross functional program teams in the past and are looking for an exciting challenge with a novel therapeutic platform at a growing company and be a part of the next generation of cancer therapies should apply.
The applicant should be local to the Seattle area.
CORE ACCOUNTABILITIES
Specific responsibilities include:
- Leads the development and authoring of clinical documents (e.g., protocols, clinical study reports, investigator brochures, and clinical summaries) in support of regulatory filings in collaboration with clinical study teams
- Supports Investigational New Drug (IND) applications, IND amendments, briefing books, GNAs, annual reports, and other documents to support global product development, including coordinating subject matter expert authorship of specific sections of clinical/regulatory documents
- Contributes to strategic publication planning and leads the development and authoring of abstracts and slides or posters presenting clinical study data at medical congresses and the development of primary manuscripts for publication in peer-reviewed journals including direct collaboration with internal and external authors
- Provides program teams with expertise and strategic guidance on analysis and presentation of
clinical and safety data and on benefit-risk assessment in documents - Organizes, conducts, and leads cross-functional document development meetings
- Develops the strategy for document preparation and manages the overall document development process including timelines, document reviews, and approvals to ensure clarity, accuracy, format, consistency, and adherence with company standard operating procedures and regulatory guidance, including the escalation of issues when required
- Represents medical writing on multiple study/project teams and contributes to program strategy, through collaborative engagement with statistical, clinical, regulatory, and pharmacovigilance colleagues
- Lead and/or participate in development of medical writing standard operating processes, templates, style standards and infrastructure development
- Contributes to clinical trial registry postings and results disclosures on US and EU platforms
- Lead the activity of, or serve as internal contact for contract Medical Writers and other providers
- Review work of other writers for accuracy, quality, focus, and adherence to format and stylistic requirements
- May eventually lead a small team
The successful candidate will have:
- Bachelor's degree with a minimum of 12 years of related experience or an advanced degree with 8 years of experience; both must include a minimum of 7 years of experience in the biopharmaceutical industry with years direct medical writing experience
- Experience in preparing clinical regulatory documents and scientific publications
- Excellent written and verbal communication skills
- Ability to influence and reach compromises cross functionally to produce a quality document
- Good understanding of other cross-functional departments/disciplines and how they contribute to the drug development process
- Experience leading and managing cross functional teams while authoring regulatory documents with aggressive timelines
- Knowledge of FDA regulations, ICH guidelines, Good Clinical Practices and the drug development process
- Flexible with the ability to learn new medical/clinical therapeutic areas and/or indications quickly
- Experience securing and deploying medical writing resources effectively and efficiently
- Must have the ability to independently coordinate and prioritize multiple projects in a fast-paced environment
Preferred Qualifications
- Expert abilities in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat preferred
- Familiarity with clinical trial transparency requirements, including ClinicalTrials.gov, preferred
- Background in oncology drug development is a plus
Physical Requirements
- Ability to sit for prolonged periods of time
- Ability to work onsite two days a week
Salary Range: $199,000 - $241,000
Benefits Offerings
Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 6% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.
