Director, Medical & Regulatory Writing

Regulatory Toolkit; Boston (MA); Vor Ort; USD 227.000 - 256.000; Vollzeit

Benefits dieser Stelle

Generous benefits

Equity

Stock options

401K

PTO 20 days

Zusammenfassung

Kura Oncology is seeking a Director of Medical Writing to serve as a subject matter expert on clinical protocols, study reports, and regulatory documents. You will guide document strategy for regulatory submissions (IND/NDA/BLA) and manage external vendors, SOPs, and templates in a fast-paced biotech setting.

The role requires extensive experience in medical writing within pharma/biotech/CRO, strong knowledge of ICH and FDA regulations, and the ability to lead complex writing projects with

Qualifikationen

• Bachelor's/Master's/PhD in scientific or clinical field required, advanced degree preferred.

Aufgaben

• Prepare clinical regulatory documents through all phases of clinical research.
• Represent medical writing in cross-functional team meetings.
• Collaborate with cross-functional groups to deliver high-quality documents on time.
• Adhere to regulatory standards including ICH-E3 and SOPs.
• Manage external vendors and develop SOPs and templates.

Kenntnisse

Regulatory writing

Project management

Detail oriented

Editing for brevity

Cross-functional collaboration

Ausbildung

Bachelor's/Master's/PhD in scientific field

Masters or PhD preferred

Tools

EndNote or RightFind Cite It

MS Word

MS Excel

MS PowerPoint

MS Project

EDMS tools (Documentum/Core Dossier/Veeva)

Jobbeschreibung

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.

At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.

To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

ESSENTIAL JOB FUNCTIONS:

The Director, Medical Writing, serves as subject matter expert on clinical protocols, protocol amendments, clinical study reports, Investigator Brochures, and briefing books. The Director, Medical Writing may also provide guidance on document strategy for more complex dossiers for regulatory submission such as IND and NDA/BLA filings. The position requires the ability to work collaboratively with cross-functional teams in a fast-paced environment. The qualified candidate will also have experience in management of external vendors and the development of operational process improvements such as work practice documents, SOP development and updates, and document templates. There will need to be a very strong understanding of document timelines as planning is critical.

• Serves as subject matter expert in preparing clinical regulatory documents through all phases clinical research.
• Represent medical writing in cross-functional team meetings.
• Collaborate with department heads and staff members of cross-functional groups, including clinical research, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs as necessary to deliver documents with high quality on time.
• Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs.
• Support the development, improvement and maintenance of medical writing work practice documents, SOPs, and document templates to ensure consistency and efficiency.
• Oversight of vendors including contract writers, QC reviewers, and document formatters.
• Must have proficiency in the use of EndNote or RightFind Cite It software for the citation of literature references and creation of list of references in Word documents.
• Maintain current knowledge of industry trends and best practices for medical writing.
• Performs other duties as assigned

JOB SPECIFICATIONS:

• Bachelor's, Masters or PhD Degree in scientific, medical, clinical discipline or related field is required. Masters or Phd degree is preferred
• A minimum of 10-12 years of relevant industry experience as a medical writer in a pharmaceutical, biotech, or CRO environment. Oncology experience preferred.
• Must have experience authoring clinical study reports, protocols, protocol amendments, Investigator's Brochure. Experience authoring and managing briefing books is a plus.
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Project management skills as related to medical writing.
• Ability to manage complex writing projects with minimal supervision.
• Must have the ability to edit text for brevity and clarity.
• Owns decision-making for their functional area or program, including resolving complex issues and making trade-offs to achieve program objectives, with minimal escalation.
• Leads cross-functional collaboration for assigned programs, proactively driving alignment across stakeholders and resolving issues to support program execution.
• Ability to understand, interpret and present complex clinical data.
• Must be highly detail oriented.
• Ability to coordinate multiple documents while effectively managing timelines.
• High degree of independence in decision making and problem solving.
• Understanding of FDA and ICH regulations and guidelines
• Familiarity with eCTD-compliant templates and with the use of document formatting tools such as ISI writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools.
• Must be an expert with MS Word and have a solid working knowledge of MS Excel, MS PowerPoint, and MS Project.
• Experience in use of an EDMS such as Documentum, Core Dossier, or Veeva.

The base range for the Director level is $227,000 - $256,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

Kura's Values that are used for candidate selection and performance assessments:

• We work as one for patients
• We are goal-focused and deliver with excellence
• We are science-driven courageous innovators
• We strive to bring out the best in each other and ourselves

The Kura Package

• Career advancement/ development opportunities
• Competitive comp package
• Bonus
• 401K + Employer contributions
• Generous stock options
• ESPP Plan
• 20 days of PTO to start
• 18 Holidays (Including Summer & Winter Break)
• Generous Benefits Package with a variety of plans available with a substantial employer match
• Paid Paternity/Maternity Leave
• In-Office Catered lunches
• Home Office Setup
• Lifestyle Spending Stipend
• Commuter Stipend (Boston Office)
• Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!

Kura Oncology is a commercial-stage biopharmaceutical company committed to discovering and developing innovative precision medicines to help patients with cancer lead better, longer lives.

Through our deep understanding of cancer biology and decades of experience in precision oncology, we are studying the underlying causes of treatment resistance. This enables us to design smart combination regimens with other cancer therapies to target tumors from multiple directions, with the goal of improving long-term clinical benefit.

Kura developed and is commercializing KOMZIFTI® (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit Kura's website at www.kuraoncology.com and follow us on X and LinkedIn.

Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

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