PRINCIPAL MEDICAL WRITER

Catalyst Clinical Research, LLC; India; Vor Ort; INR 1.200.000 - 1.800.000; Vollzeit

Zusammenfassung

A clinical research organization in India is seeking an experienced medical writer to create and review regulatory submission documents, manage projects, and conduct training programs. The ideal candidate will have over 10 years of experience in medical writing and clinical research, with strong proficiency in Microsoft Office and excellent communication skills. Responsibilities include authoring high-quality documents and ensuring adherence to regulatory standards while supporting business expansion activities.

Qualifikationen

• At least 10–11 years of experience in medical writing, drug development, and clinical research.
• 5 years of core medical writing experience focusing on regulatory deliverables.
• Scientific writing experience (publications/manuscripts) is desirable but not mandatory.

Aufgaben

• Author and review regulatory and medical writing deliverables.
• Collaborate with data analysts and statisticians.
• Deliver accurate scientific content meeting quality standards.
• Follow internal and client processes adhering to regulatory guidelines.
• Undertake quality control, scientific reviews, and proofreading.
• Conduct client interactions and teleconferences across time zones.
• Act as project lead for assigned clients.

Kenntnisse

Proficient with Microsoft Office Suite

Excellent written and oral communication skills

Excellent presentation skills

Strong organizational skills

Problem-solving and analytical skills

Ability to manage priorities and workflow

Versatility and flexibility

Strong interpersonal skills

Commitment to excellence

Ability to work independently

Jobbeschreibung

Overview

To author and review regulatory and other medical writing deliverables independently as per high-quality standards (internal and external) and within expected timelines. Support in building technical and functional expertise within the group by designing and executing robust training programs. Contribute and support other writers for manuscripts, slide sets, abstracts, posters, and other techno-commercial documents as needed.

Responsibilities

• Authoring and reviewing CSRs, Protocols, IBs, Briefing books, and other regulatory submission documents (including CTD modules) for US FDA, EMEA and other regions. Contribute to manuscripts, abstracts, posters, and other techno-commercial documents as needed.
• Collaborate with data analysts and statisticians on real-world and other evidence generation projects.
• Deliver accurate scientific content based on facts from available sources, meeting quality standards including grammar and editorial requirements.
• Follow internal and client processes and adhere to ICH, regulatory guidelines, and other industry best practices.
• Undertake quality control (QC), scientific reviews, and proofreading of the described deliverables.
• Demonstrate flexibility in timelines and writing styles based on client needs and therapeutic area requirements across various domains.
• Conduct client/KOL interactions, kickoff meetings, and teleconferences as needed across multiple time zones.
• Act as project lead or delivery lead for assigned client and maintain a healthy partnership for each account.
• Support innovation initiatives, including automation and process improvements.
• Lead robust training programs for the team and support thought leadership activities in the domain.
• Ensure audit readiness of the department. Guide development of SOPs, work instructions, and other documentation.
• Provide proactive support in business expansion and 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, and salary oversight.

Position Qualification Requirements

Education:

Experience:

At least 10–11 years of experience in medical writing, drug development, and clinical research, including at least 5 years in core medical writing (regulatory deliverables). Scientific writing experience (publications/manuscripts) is desirable but not mandatory.

Required Skills

• Proficient with Microsoft Office Suite with advanced expertise in MS Word features and macro-related functionalities.
• Excellent written and oral communication skills.
• Excellent presentation skills.
• Strong organizational, problem-solving, and analytical skills.
• Ability to manage priorities and workflow.
• Versatility and flexibility to work within changing priorities.
• Proven ability to handle multiple projects and meet deadlines.
• Strong interpersonal skills and ability to interact with a diverse group of individuals at all levels.
• Commitment to excellence and high standards.
• Creative, flexible, and innovative team player.
• Ability to work independently and as part of various teams and committees.
• Good judgment with the ability to make timely and sound decisions.