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Sr. Manager, Regulatory Writing

Orca Bio

Orca Bio

Posted on Friday, February 9, 2024
Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.
Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio’s platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.
The Senior Manager, Regulatory Writing brings a breadth of experience in writing documents for major submissions (eg, BLA, NDA) and will have the opportunity to make an immediate impact on our first BLA submission. The position reports directly to the Head of Regulatory Writing, and has an estimated start date in Q2 of 2024. Minimal travel required; position can be remote.
· Write a variety of documents for regulatory submissions (eg, CSRs, IB updates, clinical summaries) with minimal supervision
· Interact with a cross-functional team to facilitate document reviews and address comments
· Lead regulatory writing activities for investigational products in early development
· Review, edit, and format documents to conform to Orca Bio style guidelines and publishing standards
· Supervise contractors in writing a variety of regulatory documents
· Assist in developing SOPs and work instructions
· Assist in building and maintaining reference library
Required Qualifications:
- Doctorate degree with 3+ years regulatory writing experience, OR
- Master’s degree with 5+ years regulatory writing experience, OR
- Bachelor’s degree with 7+ years regulatory writing experience.
· Experience writing a variety of documents for major submissions (eg, phase 3 CSRs, clinical summaries)
· Clear and concise writing, with a strong grasp of grammar and punctuation
· Ability to summarize complex data
· Strong verbal communication skills
· Experience working with teams to gain consensus on complex issues
· Highly proficient with Microsoft Word, collaborative authoring and review tools (eg, SharePoint), and reference management software (eg, EndNote, Zotero, Mendeley)
· Ability to perform well under deadlines and adapt to unforeseen circumstances
Preferred Qualifications:
· Advanced degree (PhD, PharmD, MA)
· Education and/or writing experience in the fields of oncology and/or immunology
· Regulatory writing experience with cellular therapy
· Experience as a product regulatory writing lead
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 patients who need them.
We strive to do things right, and to embody our core values of passion, courage, and integrity. Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate daily on a path that hasn’t been paved. This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission. It means we aren’t afraid to ask “why not,” and encourage lively discourse around rethinking the status quo.
We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.
We’re proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.
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 department, and all candidates are presented through this channel only. We do not accept unsolicited resumes.