Arcellx (http://www.arcellx.com/) is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company has a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells. Arcellx’s vision is to bring ARC-sparX platform cell therapies to millions of patients who can self-administer prescribed sparX proteins under the care of academic and community practices.
Serving as a link among key functions, the Senior Medical Writer ensures that critical information is communicated with clarity, precision, and accessibility. The Senior Medical Writer works cross-functionally with Clinical Affairs, Regulatory Affairs, R&D D (including Research and Translational Sciences, and Protein Sciences), Marketing and other groups to prepare manuscripts, abstracts, reports, clinical protocols, and conduct clinical evaluations and clinical risk benefits analyses to support product development and marketing. The Senior Medical Writer contributes to tracking medical writing documents, developing templates, and training new staff.
- Prepare reports and manuscripts for submission to regulatory authorities for product approval
- Assist in preparing clinical protocols and clinical trial reports.
- Conduct formal literature searches and summarize key findings
- Maintain clinical literature library for relevant disease states and associated topics.
- Reviews, synthesizes, and translates medical literature to aid and prepare publications and regulatory submissions
- Identify and document potential clinical risks/benefits during product development.
- Create cross-functional publication plan and execute
- Collaborate with investigators and internal personnel to prepare abstracts for submission to medical societies for data presentation and peer-reviewed journals for publication.
- Lead efforts to update and submit Clinical Evaluation Reports.
- Contribute to the preparation of clinical data for analysis and report writing and regulatory submissions.
- Participate in the preparation of documents for the promotion of approved products.
- A passion for clarity in written expression.
- Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously.
- A style that is equally comfortable working independently and as part of a team.
- A body of work that demonstrates outstanding writing skills.
- A Bachelor’s degree in a scientific or health-related discipline is required with a minimum 5+ years of experience as a Medical Writer in the biotech/pharmaceutical industry or seven years of experience in clinical/scientific research, nursing, or an equivalent combination of education and experience; an advanced degree is a plus.
- Familiarity with medical terminology, and with the laws, regulations, standards, and guidance governing the conduct of clinical studies.
- Proficiency with spreadsheets and word processing applications.
- Commitment to ethical scientific investigations and rigorous experimental methods
- Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
- Sense of urgency in performance of duties
- Interpersonal skills that promote a collaborative and productive team environment
- Outstanding presentation and communication skills
Submit cover letter and resume:
Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.