Senior Manager, Regulatory Operations

Who we are…

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.

What you’ll be doing

The Senior Manager, Regulatory Operations will work within the Commercial Regulatory and Operations Group to support preparation of key submission critical documents i.e. the Clinical Study Protocol (CSP), Investigator’s Brochure, Clinical Study Report (CSR), Clinical Summaries, Chemistry, Manufacturing, and Controls (CMC), Nonclinical Reports, Suspected Unexpected Serious Adverse Reactions (SUSARs) and annual development safety update reports (DSURs). The individual will collaborate with functional area stakeholders (e.g., Clinical, Regulatory and Regulatory Operations, Safety/Pharmacovigilance, Data Management, IT etc.); along with the Medical Writer(s) to improve cross-functional processes and working standards as they relate to clinical regulatory document publishing, submission readiness and Nuvation Bio document standards.

You will be responsible for…

• Ensure correct and current clinical template usage.
• Ensure submission readiness of all clinical regulatory documents concentrating on styles, format, structure, navigation, adherence to the Nuvation Bio Style Guide and Regulatory Operations Document Standards.
• Provide clinical and safety document support to Medical Writing and Safety / Pharmacovigilance (CSPV); troubleshoot and repair document formatting and publishing (i.e. Word and PDF).
• Coordinate with Regulatory and Medical Writing Leads to collect and assemble supporting documents for the Clinical Study Report Appendices (CSR Appendices).
• Perform document publishing activities on final CSR (CSR Synopsis, CSR Body, CSR Appendices, Tables Listing and Figures (TLFs).
• Perform independent publishing QC on published reports, complete appropriate checklists and/or provide assessments for the activities around the quality of document publishing and submission readiness of source documents.
• Attend clinical document kickoffs and/or project team updates with Associate Director MW Therapeutic Area (TA) Lead and/or Lead Medical Writer to communicate document publishing activities, coordinate document timelines and gain an understanding of document handoffs.
• Work with Lead Medical Writer on updates to all clinical documents to support submission readiness activities in Word source documents and final published PDF outputs.
• Provide document publishing support to Safety/Pharmacovigilance development safety update reports (DSURs).
• Serve as the liaison between the functions and the Regulatory Operations Submissions Vendors.

What Knowledge & Experience you'll bring to us...

• BA/BS degree is desirable
• 4+ years in the pharmaceutical industry regulatory systems/operations, hands-on experience with regulatory information system software, hands-on experience with document management system software, advanced user skills using Microsoft Word and Adobe Acrobat desktop publishing techniques for regulatory submission documents, user experience within an enterprise Document Management System or an equivalent combination of education and experience are required
• Veeva RIMS experience is highly desirable
• Experience in developing processes (policy, procedure, and practices) relevant to regulatory information management systems
• Experience in developing process maps is required
• Experience in developing and delivering classroom training for regulatory information systems and/or document management systems is required
• Experience in publishing Clinical Study Reports to ICH E3 standards for use in eCTDs is required
• Advanced skills using Microsoft Word and Adobe Acrobat desktop publishing techniques for regulatory department documents is required
• An understanding of the clinical development process and the clinical regulatory document lifecycle.
• Familiarity with good clinical practices (GCP) and developing global and regional Standard Operating Procedures (SOP)s and Standard Operating Instructions (SOIs).
• Knowledge of eCTD Submissions (i.e. IND, NDA, MAA and CTA etc.).
• Knowledge of electronic document management systems (EDMS), i.e. Veeva Vault RIMS (regulatory information management systems).
• Knowledge of Life Cycle Management techniques.
• Knowledge of report publishing and submission publishing systems/software and
• Knowledge of the industry standards for desktop publishing or regulatory submission documents to eCTD readiness is required.
• Experience working within a matrix organization.

Behavioral skills to be successful...

• Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
• Emotional intelligence, curiosity, and a knack to figure out a way to build something better
• Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
• Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
• Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.

What we have for you!

• Competitive Base Salary, Bonus, and Equity Plans
• Unlimited Vacation and 10 Sick Days Annually
• Excellent Medical, Dental, and Vision Coverage
• 401K with Company Matching
• and much more!

The base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.

Disclaimer

Nuvation Bio, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.

This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Note to all external Recruiters & Staffing Agencies
All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.