Senior Manager, Commercial Operations

ZipRecruiter; Chatham (MA); Remote; USD 70,000 - 120,000; Full time

Job summary

A biopharmaceutical company seeks a remote PRC Coordinator to manage promotional materials review and support product launch initiatives. Candidates should have extensive experience in the biotech/pharma industry and proficiency in tools like Veeva PromoMats and SQL. This role involves collaboration across teams and ensuring compliance during the promotional review process.

Benefits

Medical, Dental & Vision Insurance

Retirement Savings 401k with company match

Generous Paid Time Off

Qualifications

• 7+ years of experience within the biotechnology or pharmaceutical industry.
• Familiarity with digital marketing channels and strategies.
• Experience with advanced analytics tools.

Responsibilities

• Manage promotional review committee process and compliance.
• Facilitate meetings and ensure operational success.
• Collaborate with various teams for product launch initiatives.

Skills

Veeva PromoMats expertise

Microsoft Office proficiency

Excellent interpersonal skills

Attention to detail

Education

Bachelor's Degree in Marketing, Business, Statistics, or related field

Master's degree in a relevant field

Tools

SQL

R

Python

Adobe Acrobat

Job description

Job DescriptionJob Description

About Tonix*

Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases.

Position Overview

This remote role will report into the commercial strategy lead and support two critical functions at Tonix Pharmaceuticals: Promotional Review Committee (PRC) and Commercial Strategy, including Operations/Project Management. This individual plays a critical role in the preparations for the commercial launch to support pre- and post-launch readiness and beyond. The PRC Coordinator is responsible for facilitating the promotional review committee process of assigned products for Tonix’s advertising and promotional materials. The individual will assure process compliance and efficiency of the ad/promo review cycle, including assessing that materials submitted for review are ready to progress, creating meeting agendas, managing meeting logistics and facilitating review meetings. This role is responsible for annotating materials during PRC review meetings, working with brand/business team member(s) to reconcile comments and progress materials through approval and release within established timelines. The individual also supports the processing of pre-and post-marketing submissions to the Office of Prescription Drug Promotion (OPDP). The PRC process utilizes significant cross-functional internal resources, and it is important that the PRCs are managed to function as teams that meet deadlines and adapt to the unique compliance challenges. This position is responsible for 1) managing all aspects of offline and live reviews and optimal tracking of materials during their life cycle 2) interfacing with brand/originator and regulatory to assist with system execution of Regulatory submissions, 3) and providing training to PRC team members on processes and procedures.

Essential Duties

• PRC Coordinator
  • Verify promotional materials meet established review criteria as outlined by the standard operating procedures (sop) at Tonix Pharma
  • Responsible for Tonix enterprise (Migraine and Fibromyalgia) across, Medical Affairs, Market Access, Training, Corporate Communications, and Brand
  • Route materials in accordance with PRC processes and sop
  • Prioritize reviews based on commercial deadlines
  • Create PRC meeting agendas and schedule meetings
  • Lead PRC review meetings and annotate consensus comments
  • Confirm required changes are implemented prior to subsequent review rounds
  • Manage the flow of materials and flag delays
  • Perform system administration functions for Veeva Vault PromoMats
  • Train users on PromoMats, including business champions and external partners
  • Advise PRC process owner on potential process refinements
  • Conduct prioritization exercises with brand champions and proactively flag throughput challenges to regulatory and commercial strategy lead
  • Maintain a repository for:
    • Veeva PromoMats feature updates for engagement with Managed Services
    • Refinements to SOP and best practices
  • Collaborate with team to build and measure KPIs to ensure operational completeness and efficiency to meet
    Commercial Operations
  • Provide project management and strategic leadership to support key initiatives within the remit of commercial strategy, initial support will be centered on Launch Readiness
  • Lead cross-functional teams to support product launch efforts
  • Build a comprehensive project plan and timeline
  • Track risks, issues, action items, assumptions, decisions, and dependencies
  • Document lessons learned

Necessary Skills and Abilities

• Demonstrable expertise in Veeva PromoMats: Understand all steps in standard review workflows, corrective actions/troubleshooting, annotation functionality, agenda management, and report
• Proficiency in Microsoft Office (Word, Power Point, Excel, Outlook) and Adobe Acrobat
• Experienced with proofreading complex documents · Expert listening skills and ability to probe for undisclosed information
• Excellent interpersonal skills; accurate and concise oral communications and writing ability
• Must be able to foster a team environment, collaborate cross functionally and at varying levels of experience to establish high-performing PRC Teams
• Basic knowledge of pharmaceutical promotional regulations and submission requirements
• Exceptional attention to detail
• Ability to lead & facilitate productive and efficient meetings
• Ability to manage processes/workflows, implement process improvements, & solve problems Ability to conduct process training to internal employees and vendors

Education and Experience Requirements

• Bachelor's Degree in Marketing, Business, Statistics, or a related field
• 7+ years of relevant experience within the biotechnology or pharmaceutical industry (client side).
• Experience with advanced analytics tools such as SQL, R, or Python .
• Familiarity with digital marketing channels and strategies

Qualifications

• Master's degree in a relevant field
• Experience with advanced analytics tools such as SQL, R, or Python .
• Familiarity with digital marketing channels and strategies

Recruitment & Staffing Agencies

Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes.

Compensation & Benefits

Annualized base salary ranges from $70,000 to $120,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit.

Tonix provides a comprehensive compensation and benefits package which includes:

• Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
• Pet Insurance
• Retirement Savings 401k with company match and annual discretionary stock options
• Generous Paid Time Off, Sick Time, & Paid Holidays
• Career Development and Training

Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to , , , sex, , , genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on , , , , , or expression, , , genetic, information, , veteran status, or any other characteristic protected by law.