Medical Writer Lead
hace 4 semanas
Job Summary
As a Medical Writer Lead at Syneos Health, you will be responsible for mentoring and leading less experienced medical writers on complex projects. You will act as the lead for assigned writing projects, managing medical writing activities associated with individual studies, and coordinating with departments with minimal supervision. Your expertise will be utilized to develop or support a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and IND submissions. You will also identify and propose solutions to resolve issues and questions arising during the writing process. Additionally, you will review statistical analysis plans and table/figure/listing specifications for appropriate content and grammar. You will interact with department heads and staff members in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables. As a peer reviewer, you will provide review comments on draft and final documents. You will adhere to established regulatory standards, including ICH-E3 guidelines, and Company Standard Operating Procedures. You will also maintain familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing. You will work within budgeted hours and communicate changes to medical writing leadership. You will complete required administrative tasks within specified timeframes and perform other work-related duties as assigned. Minimal travel may be required.
Responsibilities
- Mentors and leads less experienced medical writers on complex projects
- Acts as lead for assigned writing projects
- Manages medical writing activities associated with individual studies
- Develops or supports a variety of documents
- Identifies and proposes solutions to resolve issues and questions arising during the writing process
- Reviews statistical analysis plans and table/figure/listing specifications
- Interacts with department heads and staff members
- Provides review comments on draft and final documents
- Adheres to established regulatory standards
- Maintains familiarity with current industry practices and regulatory requirements and guidelines
- Works within budgeted hours and communicates changes to medical writing leadership
- Completes required administrative tasks within specified timeframes
Requirements
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred)
- 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 a familiarity with principles of clinical research and to interpret and present clinical data and other complex information
About Syneos Health
Syneos Health is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers' delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.
Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.
What We're Looking For
We are looking for a highly skilled and experienced Medical Writer Lead to join our team. You will be responsible for mentoring and leading less experienced medical writers on complex projects. You will have a strong background in medical writing, with experience in developing and supporting a variety of documents. You will also have excellent communication and leadership skills, with the ability to work effectively with department heads and staff members. You will be able to demonstrate a high degree of independence, with effective presentation, proofreading, interpersonal, and leadership skills. You will also have strong proficiency in Word, Excel, PowerPoint, email, and Internet.
How to Apply
If you are a motivated and experienced Medical Writer Lead looking for a new challenge, please submit your application. We look forward to hearing from you.
Equal Opportunity Employer
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us at: Email: ****** One of our staff members will work with you to provide alternate means to submit your application.
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