Job summary
Job post source
This job is directly from Worldwide Clinical Trials
Job overview
The Senior Medical Writer role at Worldwide Clinical Trials involves leading the creation of clinical study documents to support regulatory submissions and clinical development across multiple phases and regions, impacting the quality and compliance of clinical trial documentation.
Responsibilities and impact
The candidate will prepare and lead medical writing teams on Phase I-IV study documents including protocols, informed consent forms, clinical trial reports, and regulatory submissions, manage document templates, and collaborate with other departments to develop Pre-IND and briefing documents for regulatory authorities.
Compensation and benefits
The salary range is $80,735 to $160,265 depending on skills, experience, and location; benefits details are not specified but the company emphasizes a supportive and inclusive work environment.
Experience and skills
Candidates must have a life science or allied health degree or equivalent experience, at least 4 years as a Medical Writer or similar role, excellent English communication, strong project management, regulatory knowledge (ICH E3, E6, E9), and proficiency in Microsoft Office; flexibility for domestic and international travel is required.
Career development
The role offers opportunities for ongoing training and career development within a dynamic global medical writing team supported by leadership and administrative resources.
Work environment and culture
Worldwide Clinical Trials promotes a diverse, inclusive, collaborative, and supportive culture with accessible leadership and a focus on enabling professionals to succeed and thrive by being themselves.
Company information
Worldwide Clinical Trials is a global midsize CRO with over 3,500 employees focused on innovative clinical research to advance cures for persistent diseases, emphasizing quality and pioneering approaches.
Team overview
The medical writing team is a dynamic global group that collaborates with subject matter experts and regulatory strategists, providing comprehensive support and opportunities for professional growth.
Job location and travel
This is a remote position open to candidates in the UK or US, with required availability for domestic and international travel including overnight stays.
Unique job features
The position involves working on a wide range of clinical documents across multiple therapeutic areas and regulatory regions, with leadership responsibilities and involvement in high-level protocol and clinical development discussions.
Company overview
Worldwide Clinical Trials is a global contract research organization (CRO) that provides phase I-IV clinical trial services to the pharmaceutical and biotechnology industries. They specialize in therapeutic areas such as neuroscience, cardiovascular, metabolic, and rare diseases. Founded in 1986, the company has grown to operate in more than 60 countries, leveraging their scientific expertise and innovative technologies to deliver high-quality data and support drug development. Their revenue is primarily generated through service contracts with pharmaceutical companies, offering comprehensive clinical trial management, data analysis, and regulatory support.
How to land this job
Position your resume to highlight your medical writing expertise, especially in preparing Phase I-IV clinical study documents such as protocols, clinical trial reports, and regulatory submissions, aligning with Worldwide Clinical Trials' focus on quality and compliance.
Emphasize your knowledge of regulatory requirements and guidelines like ICH E3, E6, and E9, and your experience working with global regulatory authorities including FDA, EMA, MHRA, and Health Canada.
Apply through multiple channels, including Worldwide Clinical Trials' official corporate careers page and LinkedIn job postings, to maximize your visibility and chances of being noticed.
Connect with medical writing professionals and regulatory affairs specialists at Worldwide Clinical Trials on LinkedIn; start conversations by referencing recent company initiatives or expressing enthusiasm for their innovative approach to clinical research.
Optimize your resume for ATS by incorporating keywords from the job description such as 'medical writing,' 'clinical trial reports,' 'regulatory submissions,' 'ICH guidelines,' and 'project management' to ensure your application passes initial automated screenings.
Leverage Jennie Johnson's Power Apply feature to automate tailored resume customization, identify multiple application portals, and find relevant LinkedIn contacts, allowing you to focus your energy on preparing for interviews and networking effectively.
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