Coordinates commercial marketing operations and Medical, Legal, and Regulatory review processes for biotech promotional materials. Manages conferences, campaigns, agencies, vendors, marketing assets, project timelines, and budgets. Facilitates PRC/MRC meetings, administers Veeva PromoMats workflows, performs submission quality checks, tracks material approvals and expirations, and supports FDA Form 2253 submissions while ensuring compliance with applicable regulations.
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Position Summary: The Coordinator, Commercial Marketing & MLR (Medical/Legal/Regulatory) is a dynamic, dual-function role responsible for driving day-to-day marketing projects while helping to ensure both promotional and non-promotional content is accurate, compliant, and ready to be published. Sitting 60% within Commercial Marketing and 40% within MLR Operations, this individual will manage end-to-end conference logistics, oversee campaign workflows, and coordinate vendor operations. Concurrently, they will serve as the operational backbone for the Regulatory Review Leader by coordinating the promotional (PRC) and medical (MRC) review committee process in Veeva Vault PromoMats. They will ensure that all administrative and program management support operates effectively and in full compliance with Company policies and external regulations.
Travel & Location: ~5% to support key conferences, as needed. Preference will be given to candidates located near an Orca Bio office, particularly our Menlo Park, CA headquarters.
Essential Duties and Key Responsibilities
- Congress & Conference Management: Lead execution for national and regional medical conferences and trade shows, including booth build, routing, exhibit space registration, housing blocks, vendor logistics, material shipping, and field team communication
- Campaign & Project Tracking: Maintain the master commercial marketing calendar. Track multi-channel project milestones (digital ads, print collateral, field sales aids) to ensure agencies and internal stakeholders meet deadlines
- Agency & Vendor Coordination: Serve as the primary point of contact for external creative agencies and print vendors. Manage purchase orders (POs), review statements of work (SOWs), and assist with budget tracking and invoice processing
- Digital & Print Asset Management: Manage commercial digital and print library assets to ensure field reps and marketing managers use only active, current, and approved promotional materials. Manage the print vendor relationship and portal
- PRC/MRC Meeting Facilitation: Partner with the Regulatory Review Leader to schedule, organize, and host weekly PRC and MRC review meetings. Prepare agendas, manage live meeting flow, and record Medical, Legal, and Regulatory reviewer feedback
- Veeva PromoMats Coordination: Act as the operational administrator for Veeva Vault PromoMats, routing materials, verifying document metadata, ensuring linking of reference packages, and managing material lifecycles
- Submission Quality Checks: Perform preliminary intake QC reviews on agency submissions to ensure reference accuracy and compliant formatting prior to routing for formal PRC/MRC review
- Compliance Tracking & Material Submission: Track approval expiration dates and coordinate re-review workflows with brand managers. Partner with the Regulatory Review Leader to create and submit FDA Form 2253 packages for applicable promotional materials
Commercial Marketing Operations & Project Management (60%)
MLR Coordination & Operations (40%)
Minimum Experience and Education
- 2–4 years of marketing coordination, project management, or marketing operations experience, preferably in a pharmaceutical, biotech, or healthcare company
- Prior hands-on experience with Veeva Vault PromoMats (or a similar MLR/PRC system such as Zinc, Vodori, or Aprimo) is required
- Demonstrated background organizing commercial events and medical congresses, or managing external agency deliverables
- Basic understanding of FDA promotional regulations and guidelines (OPDP), healthcare compliance, and the Medical/Legal/Regulatory (MLR) review process
- Strong organizational skills and attention to detail, with the ability to manage multiple concurrent deadlines across internal stakeholders and external vendors
The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
Orca Biotech Menlo Park, California, USA Office
3475 Edison Way, Suite B, Menlo Park, CA, United States, 94025
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