Senior Medical Writer
hace 2 semanas
Pharmiweb is seeking a highly skilled Sr Medical Writer to join our team. As a key member of our medical writing team, you will be responsible for creating high-quality clinical documents, including clinical study protocols, clinical study reports, and regulatory submissions.
Key Responsibilities
- Mentor and lead less experienced medical writers on complex projects.
- Act as lead for assigned writing projects.
- Manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
- Develop or support a variety of documents, including clinical study protocols, clinical study reports, patient narratives, clinical development plans, IND submissions, and annual reports.
- Identify and propose solutions to resolve issues and questions arising during the writing process.
- Review statistical analysis plans and table/figure/listing specifications for appropriate content and grammar.
- Interact with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
- Serve as peer reviewer on internal review team, providing review comments on draft and final documents.
- Adhere to established regulatory standards, including ICH-E3 guidelines, and company standard operating procedures.
- Maintain familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
- Maintain awareness of budget specifications for assigned projects and work within budgeted hours.
Requirements
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English, or Communications) with relevant scientific and/or medical knowledge and expertise.
- Extensive knowledge of English grammar and FDA and ICH regulations and guidelines.
- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills.
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Ability to demonstrate familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
About Pharmiweb
Pharmiweb is a leading provider of clinical development solutions. We have worked with 94% of all novel FDA-approved drugs and 95% of EMA-authorized products over the past 5 years. Our team is passionate about developing our people and creating a culture of innovation and collaboration. We are committed to taking care of our people and providing opportunities for growth and development.
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