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Regulatory Medical Writer
155859
Posted:
28/11/2024
- Competitive
- -, - None Specified -
- Permanent
Regulatory Medical Writer
Role:
A global CRO is seeking a Medical Writer to manage client interactions and oversee the creation and review of clinical documents. You'll ensure timely project delivery, contribute to study designs, support the bidding process, and conduct training.
Responsibilities:
• Interact with clients and project management team as contact person about medical writing issues.
• Provide medical writing supervision to the project members, as needed.
• Create and review Clinical Study Protocols (for early and late phase clinical trials, non-interventional studies, PASS, etc.)
• Create and review Participant information and Informed Consent Forms for interventional and non-interventional studies.
• Participate in data cleaning activities by reviewing listings during the study conduct.
• Prepare clinical sections of New Drug Applications (NDAs.)
• Prepare and review the Investigator Brochure, Integrated Clinical Study Report (ICSR), Manuscripts and posters, and other medical/technical documents.
• Participate and contribute to writing study designs and proposals.
• Provides input into the bidding process as requested.
• Represent the company at industry conferences, present/teaching at department meetings, assist in establishing training materials etc.
• Conduct field training and assessment of Medical Writers.
• Assist in the completion of monthly KPI about the Medical Writing activities.
• Contribute to Medical Writing team knowledge by acting as process Subject Matter Expert.
Requirements:
• Graduate or postgraduate degree in Medical Sciences, Pharmaceutical Sciences, Life Sciences, Biostatistics or another relevant field
• At least 3 years of experience in clinical research
• At least 2 years of experience in medical writing activities in clinical research
• Knowledge of regulations relevant to medical writing
• Good understanding of common statistical methods used in clinical trials or pharmaceutical work and/or interpretation of their results.
• Ability to integrate, interpret, and summarize data from a variety of sources clearly and concisely.
• Excellent organizational, communication (verbal and written) and interpersonal skills.
• Proficiency in English.
• Positive attitude and ability to interact with all levels of staff.
• Ability to work under pressure and to keep tight deadlines.
Why Us?
• Join a team of knowledgeable, high-achieving, and experienced professionals.
• Experience an international and diverse work atmosphere.
• Engage in challenging projects across different therapeutic areas and early phases.
• Seize the opportunity to enrich your professional skills and progress in your career.
• Enjoy the flexibility of our work-from-home policy.
• Competitive salary and attractive social benefits.
Role:
A global CRO is seeking a Medical Writer to manage client interactions and oversee the creation and review of clinical documents. You'll ensure timely project delivery, contribute to study designs, support the bidding process, and conduct training.
Responsibilities:
• Interact with clients and project management team as contact person about medical writing issues.
• Provide medical writing supervision to the project members, as needed.
• Create and review Clinical Study Protocols (for early and late phase clinical trials, non-interventional studies, PASS, etc.)
• Create and review Participant information and Informed Consent Forms for interventional and non-interventional studies.
• Participate in data cleaning activities by reviewing listings during the study conduct.
• Prepare clinical sections of New Drug Applications (NDAs.)
• Prepare and review the Investigator Brochure, Integrated Clinical Study Report (ICSR), Manuscripts and posters, and other medical/technical documents.
• Participate and contribute to writing study designs and proposals.
• Provides input into the bidding process as requested.
• Represent the company at industry conferences, present/teaching at department meetings, assist in establishing training materials etc.
• Conduct field training and assessment of Medical Writers.
• Assist in the completion of monthly KPI about the Medical Writing activities.
• Contribute to Medical Writing team knowledge by acting as process Subject Matter Expert.
Requirements:
• Graduate or postgraduate degree in Medical Sciences, Pharmaceutical Sciences, Life Sciences, Biostatistics or another relevant field
• At least 3 years of experience in clinical research
• At least 2 years of experience in medical writing activities in clinical research
• Knowledge of regulations relevant to medical writing
• Good understanding of common statistical methods used in clinical trials or pharmaceutical work and/or interpretation of their results.
• Ability to integrate, interpret, and summarize data from a variety of sources clearly and concisely.
• Excellent organizational, communication (verbal and written) and interpersonal skills.
• Proficiency in English.
• Positive attitude and ability to interact with all levels of staff.
• Ability to work under pressure and to keep tight deadlines.
Why Us?
• Join a team of knowledgeable, high-achieving, and experienced professionals.
• Experience an international and diverse work atmosphere.
• Engage in challenging projects across different therapeutic areas and early phases.
• Seize the opportunity to enrich your professional skills and progress in your career.
• Enjoy the flexibility of our work-from-home policy.
• Competitive salary and attractive social benefits.