Description

Ventyx Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical needs with novel oral therapies that shift the immunology markets from injectables to oral drugs. Our current pipeline includes four clinical-stage programs targeting TYK2, S1P1R and NLRP3, thereby positioning us to become a leader in the development of oral immunology drugs. Join this team of life science professionals to bring this portfolio of programs to fruition.

The Opportunity: Manager, Medical Writing 

The Manager, Medical Writing position will be responsible for leading the medical writing activities for one or more development programs. This role will manage the timely development and completion of Clinical and Regulatory documents that may be submitted to regulatory agencies and authorities. The role will represent medical writing on cross-functional study teams and partner with cross-functional colleagues to develop documents to support company goals. This position reports to the Senior Director, Medical Writing.

What You Will Contribute:

• Generate Clinical and Regulatory documents and other materials for internal and external use (e.g., Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, Annual Reports, and Development Safety Update Reports).
• Proactively interact with other members of the organization to ensure the timely preparation and receipt of information required for Clinical documents and Regulatory submissions.
• Collaborate with cross-functional team members to ensure Medical Writing deliverables are complete, well organized, scientifically accurate, timely, and messaging is consistent throughout all documentation.
• Provide review and editing of documents and deliverables on multiple projects simultaneously.
• Oversee work by medical writing vendors and clinical research organizations contracted to perform writing duties, as needed.
• Ensure adherence to SOPs and retain needed documentation. 
• Provide expertise on document organization, content, and timelines.
• Represent Medical Writing on cross-functional project teams.
• Support the growth of the function by providing input on the development of medical writing SOPs and writing tools such as templates and style manuals.
• Keeps abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.
• Additional duties assigned as needed.

What We Seek:

• Bachelor's Degree 5 years in life sciences or related discipline; or PhD 2 years in life sciences or related discipline required
• 2 years of medical/scientific writing experience with clinical and regulatory documents for a pharmaceutical or biotechnology company required
• Understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
• Familiarity with FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and submissions
• Prior knowledge of eCTD submissions structure
• Ability to understand and summarize complex results and present them in a clear, concise, and scientifically accurate manner
• Prior experience working at a small company with wide-ranging responsibilities desired
• Excellent attention to detail and accuracy
• Demonstrated agility to learn, prioritize multiple responsibilities independently, and drive projects to completion
• Strong oral & written scientific communications skills especially in writing very technical concepts 
• Ability to strike a balance between independent work and team interaction, be a team player in a cross-functional team
• Well-developed interpersonal skills, with experience in interacting with different people and building strong positive relationships
• Significant experience using Microsoft Office Suite including Project, Excel, PowerPoint required; experience with SharePoint or similar work management software/systems highly preferred
• An aptitude to learn new software and systems
• Passion for science
• Ability to travel as needed

What We Provide to You:

• The opportunity to make a difference in people’s lives impacted by autoimmune and inflammatory diseases.
• Participate in a team of life science professionals who value science, data, high work ethic and a meritocracy; access to all levels of the organization to get work done with a sense of urgency.
• Competitive compensation and a comprehensive benefit package, including stock options.

The anticipated annual base salary range for this role is $111,000 to $140,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, company needs, and market factors. Ventyx is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, LTD, time off, a retirement plan, and other voluntary benefits for employees.

Ventyx is an equal opportunity employer and strives to maintain a work environment in which all individuals are treated with respect and dignity. Qualified applicants will receive consideration for employment without regard to race, age, ethnicity or national origin, color, religion, sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender identity, sexual orientation, disability or medical condition (including genetic information or characteristics or those of a family member), military service or veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

Notice to Recruiters and Agencies:

The Human Resources team manages the recruitment and employment process for Ventyx Biosciences. To protect the interest of all parties involved, Ventyx Biosciences does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing or recruiting agencies or fee-based referral services. The submission of referrals or resumes by anyone other than a candidate directly to Ventyx Biosciences’ employees is strictly prohibited. Unsolicited referrals and resumes sent to Ventyx are deemed gratuitous, and do not obligate Ventyx to pay fees should we hire from those resumes. Recruiters are requested NOT to contact or present candidates directly to our hiring managers or employees. Please direct all inquiries to careers@ventyxbio.com.