Senior Oncology Medical Writer & Regulatory Lead
Treeline
Treeline Biosciences is seeking an Associate Director / Director, Medical Writing in Oncology to author and coordinate high-quality regulatory and clinical documents across the product lifecycle. You will own documents end-to-end and coordinate with Regulatory, Clinical Development, Biostatistics, and vendors to ensure submission-ready quality. The role requires 8+ years of oncology regulatory writing experience, strong scientific writing, and the ability to work independently while guiding #J-18808-Ljbffr Treeline
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Oncology Medical Writer & Regulatory Lead in Watertown, MA vacancy
- Parabilis Medicines is seeking an Associate Director, Regulatory Affairs to lead regulatory strategy and execution across the product lifecycle in Cambridge, MA. This role focuses on advancing programs through optimized regulatory plans, with emphasis on NDA/BLA submissions...SeniorRegulatory
- About the role The Senior Director, Oncology Search & Evaluation will advance the... ...scientific, clinical, regulatory, and competitive insights into... ...discovery through commercial). Lead scientific, strategic, and... ...externally at scientific/medical/partnering forums. Lead/influence...SeniorRegulatory
- ...health issues today and address the medical challenges of tomorrow. We... ...therapeutic areas including immunology, oncology and neuroscience - and products... .... Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins is...SeniorRegulatoryFull timeLocal area
AbbVie Inc.
Cambridge, MAa month ago - Title:Senior Medical Director, Global Medical Affairs - Neurosciences (Migraine Lead) Company:Ipsen Biopharm Ltd About Ipsen Ipsen is a... ...in three therapeutic areas: Oncology, Rare Disease and Neuroscience... ...Commercial, Market Access, Regulatory, and R&D. Drive the...SeniorRegulatory
- ...Cambridge, MA is seeking a Senior Clinical Pharmacology... ...) to provide strategic medical guidance for... ...decision point programs in oncology. The role is hybrid with... ...outcomes. The CPL will lead development strategies,... ...ensure alignment with regulatory requirements and SOPs....SeniorRegulatoryLocal area
- ...Americas, Inc. seeks a Sr. Manager, Statistics to lead statistical design, analysis and reporting for oncology clinical trials, and to represent statistics on global drug development teams. The role supports regulatory submissions, study protocols, SAPs and CSRs with a...SeniorRegulatoryRemote job
- Sanofi in Cambridge, MA seeks a Senior Clinical Research Director... ...clinical development and regulatory activities. You will lead protocol development, study oversight, and medical input for submissions,... ...requires MD-level expertise, oncology specialization, fluent English...SeniorRegulatory
$212k - $333.19k
...DescriptionAbout the role:The Senior Director, Oncology Search & Evaluation will be... ...scientific, clinical, regulatory, and competitive insights into... ...a demonstrated ability to lead in a highly matrixed global... ...externally at major scientific, medical, and partnering forums to...SeniorRegulatoryMinimum wageLocal areaRemote work- [Voronoi, Inc.] Medical Writer (Hybrid Work) Medical Writer - Oncology Clinical Trials Location: minimum 2 days onsite in Waltham, MA office Cambridge / Greater... ...a proven track record of preparing high-quality regulatory and scientific documents in support of clinical...RegulatoryFor contractors
- ...compliance, and strategic oversight. In this hybrid role, you will mentor staff, develop process guides, and resolve complex policy questions, balancing regulatory requirements with operational needs across departments. #J-18808-Ljbffr Harvard Faculty of Arts and SciencesSeniorRegulatory
- Regeneron Pharmaceuticals, Inc. in New York seeks a Senior Toxicologist to lead nonclinical development programs with guidance from a supervisor... ...ability to independently design, conduct, and interpret regulatory toxicology studies in rodent and non-rodent models,...SeniorRegulatory
- Biogen is seeking a Senior Director, Immunology Early Development Strategy & External Innovation to lead strategic initiatives bridging discovery and early development across... ...programs, and ensure compliance with regulatory and quality standards #J-18808-Ljbffr BiogenSeniorRegulatory
- Initial Therapeutics, Inc. is looking for a Senior Advisor in Manufacturing Science and Technology to manage external manufacturing activities... ..., and ensuring timely delivery of materials while authoring regulatory documents. #J-18808-Ljbffr Initial Therapeutics, Inc.SeniorRegulatory
- Jobtailor is seeking a Pharmacovigilance Lead in Cambridge, MA to manage signal detection, safety reporting, and regulatory interactions. You will finalize PSURs/DSURs and mentor a safety team, collaborating with Clinical Development and Regulatory groups. The role requires...SeniorRegulatory
- A biotechnology company in Cambridge, MA is looking for a Senior Director of Biostatistics to lead statistical activities for clinical programs, provide input during regulatory submissions, and mentor junior statisticians. This role demands expertise in statistical analysis...SeniorRegulatory
- Regeneron seeks a Senior Toxicologist to lead nonclinical development programs with guidance from a supervisor, applying GLP regulations and FDA... ...to independently design, conduct, analyze, and report regulatory toxicology and exploratory studies in rodent and non-rodent...SeniorRegulatory
- A clinical-stage biotechnology company is seeking a Medical Writer to lead the development of regulatory and clinical documents. The role requires expertise in medical writing and collaboration with various teams to ensure high-quality documentation. Candidates should...SeniorRegulatory
PepGen
Boston, MA2 days ago - Regeneron is seeking a Senior Toxicologist to lead nonclinical development programs with regulatory oversight and cross‑functional collaboration. The role requires deep GLP and regulatory expertise to design, conduct, and report studies in rodent and non‑rodent models...SeniorRegulatory
- Relay Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs, develop global submission plans, and coordinate cross-functional teams to ensure regulatory success...SeniorRegulatory
- Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Toxicologist to lead nonclinical development programs with guidance from their supervisor... ...for designing, conducting, interpreting, and reporting regulatory toxicology studies and related pharmacology work in...SeniorRegulatory
- ...Job Description Job Description Scientist/Senior Scientist, Biology Lead – Kidney Experience About the Role We are seeking a highly motivated... ...closely with chemistry, delivery, translational, regulatory, and external teams · Help define scientific strategy...SeniorRegulatory
RAPTOR MEDICINES INC
Allston, MA29 days ago - ...experience with biomedical equipment and capacity to educate clinical staff on system integration. The position emphasizes leadership, regulatory compliance, and continuous improvement, with travel to sites as needed and collaboration with #J-18808-Ljbffr TriMedx, LLCSeniorRegulatory
$179k - $236k
Reporting to the Chief Scientific Officer, this role leads DMPK and bioanalytical strategy across nonclinical and clinical programs,... ...leadership and external stakeholders Author nonclinical sections of regulatory filings (e.g., IND) and briefing documents; support agency...SeniorRegulatory- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for ensuring that the organization gains regulatory approval for new products and product amendments, while maintaining the currency of...SeniorRegulatoryFull timeLocal area
- Treeline is seeking a Senior Clinical Trial Manager with oncology-focused Clinical Operations experience to join our growing Clinical Development group... ...overseeing CRO activities to ensure compliance with ICH/GCP, regulatory rules, and SOPs; #J-18808-Ljbffr TreelineSeniorRegulatory
- Novartis in Cambridge, MA seeks a senior Nonclinical Safety leader to drive global safety programs across modalities, ensuring regulatory-compliant strategies that support clinical entry... ...teams and Health Authorities. You will lead safety strategy, author IND/NDA sections...SeniorRegulatory
- ...12 months is to advance our lead in vivo development candidate... ...Characterizing Your Impact: As the Senior Director, Program Team Lead... ...Nonclinical, CMC, Quality, Regulatory, and Development... ...a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health...SeniorRegulatoryWork at officeFlexible hours
Editas Medicine
Cambridge, MA24 days ago $210k - $270k
...Summary The Vonjo Core Asset Team (CAT) Lead is a senior cross-functional lead accountable for... ...for VEXAS, lifecycle management (LCM), regulatory and commercial readiness, and long-term... ...with asset strategy, guiding clinical, medical, and real-world data priorities to...SeniorRegulatoryFull timeTemporary workLocal areaSobi
Waltham, MA11 days ago- Novartis Group of Companies in Cambridge, MA, seeks a senior leader to provide global, end-to-end nonclinical safety leadership across oncology modalities, ensuring robust, regulatory-focused safety strategies for clinical trial initiation and registration. This hybrid...SeniorRegulatoryRelocation package
- Pfizer is seeking a Medical Director to provide Clinical Development leadership for the PF 4404 program, overseeing trial design, conduct, and analysis while collaborating with regulatory affairs, pharmacovigilance, biostatistics, and medical affairs. The role requires...SeniorRegulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Oncology Medical Writer & Regulatory Lead. Be the first to apply!
Related searches
- senior medical science liaison Watertown, MA
- senior software engineer remote Watertown, MA
- senior performance engineer Watertown, MA
- senior manager m&a tax Watertown, MA
- senior living Watertown, MA
- senior performance tester Watertown, MA
- senior ux designer remote Watertown, MA
- senior director continuous improvement Watertown, MA
- senior director it Watertown, MA
- senior vice president of operations Watertown, MA