PRINCIPAL MEDICAL WRITER
# PRINCIPAL MEDICAL WRITER **Catalyst Clinical Research** · India · `Remote` · `Full Time` 💼 **Уровень роли:** `Senior` 🕒 **Статус:** *Опубликовано: сегодня* · *Источник: Himalayas (JSON API)* --- ### Top Skills & Match 🎯 **Ключевой стек роли:** `[Medical-Writer]` `[Regulatory-Writing]` `[Clinical-Writer]` `[Medical-Communications-Specialist]` `[Scientific-Writer]` `[Principal-Medical-Writer]` `[Lead-Medical-Writer]` `[Senior-Medical-Writer]` --- ### About the Role Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com. To author and review regulatory & other medical writing deliverables independently as per high-quality standards (internal & external) and within expected timelines. Support in building technical & functional expertise within the group by designing & executing robust training programs. Contribute/support other writers for manuscripts, slide sets, abstracts, posters, other techno-commercial documents as needed. - Authoring & reviewer of CSRs, Protocol, IB, Briefing books & other regulatory submission documents (including CTD modules) for US FDA, EMEA and rest of the world. Additionally, contribute to manuscripts, abstracts, posters, other techno-commercial documents as needed. - Work with data analysts and statisticians on Real world and other evidence generation projects. - Author deliverables with scientific accuracy, based on facts from available sources and meeting quality standards (including grammar and editorial requirements). - Follow all internal and client processes and adhere to various ICH / regulatory guidelines and other industry best practices. - Undertake quality control (QC, scientific reviews and/or proofreading of the above-mentioned deliverables. - Showcase flexibility in terms of timelines and writing style based on client needs and/or therapeutic area requirements across various domains. - Conduct client/KOL interactions, kickoff meetings, and teleconferences as needed covering various time zones in an effective manner. - Act as project lead/delivery lead for assigned client and responsible for healthy partnership for each account. - Support innovation initiatives, including but not limited to automation and process improvement. - Conduct robust training programs for the team & support thought leadership activities in the domain. - Responsible for audit readiness of the department overall. Guide development of the SOPs, work-instructions and other documentation. - Support proactively in business expansion & department operation activities as needed. Managerial Requirements/ Responsibilities: Position will have management responsibilities. Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, coaching/performance management, goal setting, & salary. Position Qualification Requirements : Education: PharmD, M. Pharm, PhD, MD, Post-graduate degree in Life science/medical/para medical Experience: At least 10- 11 years of experience in medical writing, drug development, clinical research, out of which at least 5 years in core medical writing (regulatory deliverables). Scientific writing (publication/manuscripts etc) experience is desirable but not mandatory. Required Skills : - Proficient with Microsoft Office Suite. Advance level expertise for MS WORD features and macro relation functionalities. - Excellent written and oral communication skills. - Excellent presentation skills. - Strong organizational, problem-solving, and analytical skills. - Ability to manage priorities and workflow. - Versatility, flexibility, and a willingness to work within constantly changing priorities. - Proven ability to handle multiple projects and meet deadlines. - Strong interpersonal skills. - Ability to deal effectively with a diversity of individuals at all organizational levels. - Commitment to excellence and high standards. - Creative, flexible, and innovative team player. - Ability to work independently and as a member of various teams and committees. - Good judgment with the ability to make timely and sound decisions. Originally posted on Himalayas
- Medical-Writer
- Regulatory-Writing
- Clinical-Writer
- Medical-Communications-Specialist
- Scientific-Writer
- Principal-Medical-Writer
- Lead-Medical-Writer
- Senior-Medical-Writer
Наблюдалась 2026-10-03, впервые 2026-10-03, источник — Himalayas (JSON API).