Report Writer

5-8 years

Not Disclosed

Ahmedabad

10 June 25, 2024

Job Description

Job Type: Full Time Education: M.Pharm / P.hd Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Report Writer

Company: Veeda Clinical Research Limited
Location: Ahmedabad, India
Position: Report Writer
Experience: 5-8 Years
Qualification: M.Pharm / Ph.D.

About Veeda Clinical Research Limited

Veeda Clinical Research Limited is a leading global clinical research organization headquartered in Ahmedabad, India. We are dedicated to providing high-quality clinical research services to the pharmaceutical, biotechnology, and medical device industries. Our mission is to deliver excellence in clinical trials with a commitment to scientific integrity, regulatory compliance, and the highest ethical standards.

Job Summary

As a Report Writer at Veeda Clinical Research Limited, you will be responsible for preparing comprehensive and accurate clinical study reports, regulatory submissions, and scientific publications. Your role will involve synthesizing complex clinical data into clear, concise, and well-structured documents that meet regulatory and company standards. You will collaborate with various stakeholders to ensure the timely and high-quality delivery of reports and documents.

Key Responsibilities

Report Writing:
- Prepare detailed clinical study reports, including methodologies, results, and conclusions, ensuring accuracy and clarity.
- Develop and write regulatory submission documents such as Investigational New Drug (IND) applications, New Drug Applications (NDA), and Clinical Study Reports (CSR).
Data Analysis and Interpretation:
- Analyze and interpret clinical trial data to ensure accurate and comprehensive presentation of study findings.
- Collaborate with biostatisticians and clinical research teams to ensure data accuracy and integrity.
Document Preparation:
- Draft, review, and finalize scientific manuscripts, abstracts, posters, and presentations for conferences and publications.
- Ensure that all documents adhere to regulatory requirements, guidelines, and company standards.
Collaboration and Communication:
- Work closely with clinical research associates, project managers, investigators, and regulatory affairs teams to gather necessary information and ensure document accuracy.
- Communicate effectively with internal and external stakeholders to address any questions or concerns regarding report content.
Quality Assurance:
- Ensure that all documents undergo thorough quality checks and reviews for consistency, accuracy, and compliance.
- Implement feedback from internal and external reviewers to improve document quality.
Regulatory Compliance:
- Stay updated with current regulatory guidelines and industry best practices to ensure compliance in all written documents.
- Ensure that all submissions meet the regulatory requirements of relevant health authorities (e.g., FDA, EMA).
Continuous Improvement:
- Participate in the development and maintenance of standard operating procedures (SOPs) related to report writing and document preparation.
- Contribute to continuous improvement initiatives to enhance the efficiency and quality of the report writing process.

Qualifications and Skills

Educational Background:
- Master’s degree in Pharmacy (M.Pharm) or Doctorate (Ph.D.) in a relevant scientific discipline.
Experience:
- 5-8 years of experience in medical or scientific writing, preferably within the pharmaceutical or clinical research industry.
Technical Skills:
- Strong understanding of clinical research processes, regulatory requirements, and GCP guidelines.
- Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint) and document management systems.
Writing Skills:
- Excellent writing and editing skills, with the ability to convey complex scientific information clearly and concisely.
- Strong attention to detail and accuracy in all written documents.
Analytical Skills:
- Strong analytical and critical thinking skills to interpret clinical data and draw accurate conclusions.
- Ability to synthesize information from multiple sources into cohesive and comprehensive reports.
Interpersonal Skills:
- Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams.
- Ability to work independently and as part of a team in a fast-paced environment.
Organizational Skills:
- Strong organizational and time-management skills.
- Ability to manage multiple projects and meet deadlines consistently.

What We Offer

Competitive salary and benefits package.
Opportunities for professional growth and development.
A supportive and collaborative work environment.
The chance to contribute to high-quality clinical research and regulatory submissions.

How to Apply

Interested candidates are invited to submit their resume and a cover letter detailing their relevant experience and qualifications to careers@veedacr.com with the subject line "Application for Report Writer."

Join Veeda Clinical Research Limited and be part of a team dedicated to advancing medical science and improving patient outcomes through high-quality clinical research and scientific writing.

Note: This job description is intended to provide a general overview of the position and may include other responsibilities and qualifications as required by Veeda Clinical Research Limited.