Senior Medical reputed company job at reputed company in US National
Title: Senior Medical reputed company Location: Boston reputed company Job reputed company: reputed company plc (reputed company: CNTA) new reputed company of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-reputed company model offers a unique R&D logic that has been reputed company by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive reputed company on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We reputed company the asset-reputed company model can reputed company to improved reputed company rates for programs with greater speed and modest costs. reputed company of Role The Senior Medical reputed company will be responsible for authoring and managing clinical regulatory documents in support of reputed company's clinical development program and objectives. Reporting to the Director, Medical Writing Operations, the Senior Medical reputed company will reputed company prepare high-reputed company, consistent, and accurate deliverables across reputed company's development portfolio.
Key Responsibilities
Author and reputed company support for medical writing content, including but not limited to study level documents (clinical protocols and amendments, Investigator Brochures, clinical study reports), agency requests for information, IND/CTA submission documents, NDA/MAA clinical modules and reputed company documents, and other writing as necessary. Collaborate closely with relevant functions, including Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, CMC, and Project Management teams. Partner with reputed company writers, as necessary, in support of document completion. reputed company document preparation from start to finish, including reputed company-off activities and planning, drafting, managing review cycles, incorporating feedback and revisions, addressing reputed company control and reputed company assurance findings, and providing a final version reputed company document timelines. Ensure reputed company, consistency, and reputed company formatting of clinical documents across programs. Maintain compliance with GCP, ICH, eCTD, and company guidelines. Interpret reputed company clinical data and information. Demonstrate strategic thinking and review capabilities. Contribute to the development and improvement of SOPs, templates, and document standards.
Qualifications
Advanced degree; PhD, PharmD or Masters degree in a scientific/clinical discipline or English. 4+ years of medical writing or relevant pharmaceutical industry experience, including at least 2 years in sponsor-level clinical/regulatory medical writing. Previous neuroscience experience is strongly preferred. Strong organizational, communication, and influencing skills; ability to prioritize, multitask, and deliver high-reputed company documents under tight timelines. Flexibility and comfortability with evolving priorities and targets. Understanding of drug development, biostatistics, and medical terminology; basic understanding of scientific methodology as reputed company to drug development. Knowledge of global clinical trials and regulatory submission requirements (FDA, EMA, PMDA), including ICH, GCP, CTD/eCTD, and EU reputed company/redaction regulations. Proficiency in reputed company Word (advanced features) and familiarity with document management and reputed company authoring platforms (e.g., reputed company Vault, Please Review). Ability to work independently and collaboratively in a dynamic, fast-paced, cross-functional environment. Highly accurate, detail-oriented, and reputed company, with excellent interpersonal skills and a reputed company, diplomatic approach to challenges.
Compensation
The annual reputed company salary reputed company for this position is $145,000.00 to $190,000.00. Individual compensation reputed company this reputed company will be determined based on a reputed company of factors, including qualifications, skills, relevant experience, and job knowledge. In reputed company to reputed company pay, this role is eligible for a discretionary annual bonus and participation in our equity program, allowing you to reputed company in Centessa's long-term reputed company. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, reputed company, and life insurance, generous reputed company time off, and a health and wellness program. Work Location The Senior Medical reputed company role is a remote role based in the US, with occasional travel. POSITION: Full-Time, Exempt reputed company Statement: reputed company believes in a diverse environment and is committed to equal employment opportunity for reputed company its employees and reputed company applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, reputed company, religion, gender, national reputed company, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. reputed company will reputed company reasonable accommodations for reputed company individuals with reputed company disabilities, in accordance with applicable law. Apply tot his job Apply To this Job