Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.
We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.
Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.
We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.
With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.
The Senior Director / Director, Medical Writing is responsible for independently authoring and delivering high-quality routine clinical and regulatory documents and represents Medical Writing as a cross-functional team member for clinical study-level activities. This role will also manage and oversee outsourced Medical Writing activities and timelines with functional service providers and CROs.
This position will report directly to the SVP, Clinical Operations & Program Management.
Position Responsibilities:Independently writing and delivering high-quality clinical and regulatory documents (e.g., clinical study protocols, clinical study reports, investigator’s brochures, integrated summaries, and sections of regulatory submissions) in partnership with internal cross-functional team members and CRO partnersCoordinating effective document development, review, and approvalOverseeing medical writing vendor writers for individual projectsActively contributing to development of processes and procedures to improve departmental and cross-functional workflowsBuilding relationships and working collaboratively with study team members and CRO/FSP partnersReviewing study and program-level documents for clarity, accuracy, and consistencyDeveloping in-depth study-level and program knowledgeContributing scientific knowledge and analytical skills to the production of documentsParticipating in developing key messages for clinical regulatory documentsDeveloping document timelines and communicating with team members to maintain awareness of expectations, milestones, and deliverablesLeading development of clinical trial registry postings for assigned studiesNavigating an electronic document management system and related tools to develop clinical documentsCandidate Requirements:Bachelor's degree in biomedical science required, (PhD advantageous). 10+ years of experience in the pharmaceutical/biotechnology industry as a medical writer and line managerSelf-motived and nimble with the ability to excel in a fast-paced environmentExcellent written and verbal communication skillsStrong interpersonal skillsExperience producing high-quality scientific/medical documentsAbility to analyze, interpret, and summarize clinical dataBasic understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminologyStrong project management and organizational skillsInitiative and creativity in solving routine problems for individual documents and in identifying process improvements within the Medical Writing departmentAttention to detail related to consistency, grammar, syntax, and scientific accuracyProficiency in word processing, templates, table/figure creation, and literature searchesCullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
