Medical Content Specialist Lead
3 days ago
About Us
Syneos Health is a pioneering biopharmaceutical solutions organization dedicated to accelerating customer success through innovative clinical development strategies. With a strong focus on translating insights into actionable outcomes, we drive modern market realities for our clients.
Our Clinical Development model puts the customer and patient at the forefront of everything we do. We continuously strive to simplify and streamline our processes to make Syneos Health an easier partner and employer. Whether you collaborate with us as a Functional Service Provider or in a Full-Service environment, you'll work alongside passionate problem solvers who innovate together to achieve our customers' goals. Our agility enables us to accelerate therapy delivery because we're driven to change lives.
Discover what over 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- We are committed to developing our people through career growth opportunities, supportive line management, technical training, peer recognition, and competitive rewards programs.
- We prioritize our Total Self culture – where authenticity shines. This culture unites us globally, and we're dedicated to taking care of our team members.
- We continuously build the company we all want to work for and our customers desire to collaborate with. Why? Because diverse perspectives, backgrounds, cultures, and thoughts bring about a place where everyone feels like they belong.
Job Responsibilities
As a Medical Content Specialist Lead, your key responsibilities will include mentoring and guiding less experienced medical writers on complex projects when necessary, leading assigned writing projects, managing medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision, developing or supporting various documents, such as clinical study protocols, clinical study reports, patient narratives, clinical development plans, IND submissions, annual reports, integrated summary reports, NDA and (e)CTD submissions, investigator brochures, and clinical journal manuscripts, abstracts, and client presentations. You'll also identify and propose solutions to resolve issues and questions arising during the writing process, review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency, interact with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables, serve as a peer reviewer on internal review teams providing review comments on draft and final documents, adhere to established regulatory standards, including ICH-E3 guidelines, Company Standard Operating Procedures, client standards, and approved templates when completing medical writing projects on-time and on-budget, perform online clinical literature searches, maintain familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing, maintain awareness of budget specifications for assigned projects working within budgeted hours and communicating changes to medical writing leadership, complete required administrative tasks within specified timeframes, and perform other work-related duties as assigned.
Qualifications
- A Bachelor's degree in relevant fields with significant writing experience or a Bachelor's degree in Social Sciences, English, or Communications with relevant scientific and/or medical knowledge and expertise is preferred.
- Extensive knowledge of English grammar, FDA and ICH regulations, and guidelines, as well as a familiarity with AMA style guides, is essential.
- Demonstrated independence with effective presentation, proofreading, interpersonal, and leadership skills, ensuring a team-oriented approach is crucial.
- Strong proficiency in Microsoft Office applications, particularly Word, Excel, PowerPoint, email, and Internet, is required.
- The ability to demonstrate familiarity with principles of clinical research and interpret and present clinical data and complex information is vital.
Salary Range
The estimated salary range for this position is between $60,930 and $115,100 per annum based on qualifications, skills, competencies, and experience.
Benefits
- We offer competitive benefits, including a comprehensive health insurance package, retirement plan, paid time off, and professional development opportunities.
- Our Total Self culture prioritizes employee well-being, diversity, equity, and inclusion, making Syneos Health a great place to work and grow.
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