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Senior Medical Writing Consultant

2 months ago

Bengaluru, India MS CLINICAL RESEARCH Full time
Position Title: Senior Medical Writing Consultant (Part-Time)
Company: MS Clinical Research Pvt Ltd
Location: Bengaluru
Employment Type: Part-Time
Experience Required: 10+ years
About MS Clinical Research Pvt Ltd:
MS Clinical Research Pvt Ltd is a leading contract research organization committed to providing high-quality clinical research services. We specialize in delivering comprehensive solutions for clinical trials, regulatory affairs, data management, and medical writing. Our mission is to enhance improve patient outcomes.
Position Overview:
MS Clinical Research Pvt Ltd is seeking a highly experienced and motivated Senior Medical Writing Consultant to join our team on a part-time basis. The successful candidate will play a crucial role in developing and leading our medical writing team, ensuring the delivery of high-quality documents that support clinical research and regulatory submissions.
Key Responsibilities:
Team Development:
Mentor and provide guidance to the medical writing team, fostering a culture of excellence and continuous improvement.
Conduct training sessions and workshops to enhance the skills and knowledge of the team members.
Medical Writing:
Lead the development and review of clinical trial documents, including protocols, clinical study reports, informed consent forms, investigator brochures, and regulatory submissions.
Ensure all documents comply with regulatory requirements, industry standards, and company guidelines.
Provide strategic input on document planning, content, and structure.
Quality Assurance:
Establish and maintain quality control processes to ensure the accuracy, consistency, and clarity of all medical writing deliverables.
Conduct peer reviews and provide constructive feedback to team members.
Project Management:
Manage multiple medical writing projects simultaneously, ensuring timely delivery of high-quality documents.
Collaborate with cross-functional teams, including clinical operations, biostatistics, regulatory affairs, and project management, to ensure alignment and successful project outcomes.
Regulatory Knowledge:
Stay updated with the latest regulatory requirements and guidelines related to medical writing and clinical research.
Provide expert advice on regulatory submissions and documentation strategies.
Qualifications:
Advanced degree in life sciences, medical writing, or a related field (PhD, MD, or equivalent preferred).
Minimum of 15 years of experience in medical writing within the pharmaceutical, biotechnology, or clinical research industry.
Proven track record of leading and developing high-performing medical writing teams.
Extensive knowledge of regulatory requirements and guidelines (e.g., ICH, GCP, FDA, EMA).
Strong project management skills with the ability to manage multiple projects and meet deadlines.
Excellent written and verbal communication skills.
Attention to detail and commitment to producing high-quality work.
Proficiency in Microsoft Office Suite and medical writing software/tools.
Benefits:
Competitive salary and compensation package.
Flexible working hours and remote work options.
Opportunity to work with a dynamic and collaborative team.
Professional development and growth opportunities.