Senior Medical Writer & Evidence Analyst

Catalyst Clinical Research, LLC; India; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A leading clinical research organization in India is seeking an experienced Senior Medical Writer & Evidence Analyst to author and review regulatory documents and medical writing deliverables. The role requires 3-5 years of medical writing experience, proficiency in MS Office, and excellent communication skills. Responsibilities include independent authoring of manuscripts and ensuring quality in deliverables. The position offers a dynamic work environment with flexible timelines and collaboration across various teams.

Qualifications

• At least 3-5 years of experience in medical writing or flair for writing.
• Fair understanding of industry standards and global trends in drug development.
• Basic understanding of automation platforms.

Responsibilities

• Author and review regulatory submission documents for US FDA and EMEA.
• Independent authoring of manuscripts and evidence synthesis projects.
• Quality control and proofreading of deliverables.

Skills

Excellent written and oral communication skills

Proficient with Microsoft Office Suite

Strong organizational skills

Problem-solving skills

Ability to manage priorities and workflow

Education

Relevant certification preferable

Tools

MS Office

Job description

Senior Medical Writer & Evidence Analyst

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, review regulatory & other medical writing deliverables independently or with other Sr Medical Writer as per high-quality standards (internal & external) and within expected timelines. Support other writers for manuscripts, slide sets, abstracts, posters, other techno-commercial documents as needed.

Position Responsibilities/

Accountabilities:

• Authoring & review of patient narratives, CSRs, Protocol, IB, & other regulatory submission documents (excluding CTD modules) for US FDA, EMEA and rest of the world.
• Independent authoring and review of manuscripts, abstracts, posters, evidence synthesis projects and other techno-commercial documents as needed.
• 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 (e.g. GPP).
• 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.
• Support audit readiness of the department overall. Contribute to development of the SOPs, work-instructions and other documentation.
• Support individual and department development goals for larger business needs.

Education:

Experience:

At least 3-5 years of experience in medical writing or flair for writing with proven academic standards. Fair understanding of industry standards and global trends in drug development and medical device domains. Highly proficient in MS Office and other software for authoring and data handling/interpretation. Basic understanding and comfort for use of automation platforms.

Required Certifications : Relevant certification is preferable but not mandatory

• Proficient with Microsoft Office Suite. Mid to Advance level expertise for MS WORD features.
• 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 judgement with the ability to make timely and sound decisions