Sr Medical Writer (Drug Development/Late Phase Exp)

Overview

Sr Medical Writer (Drug Development/Late Phase Exp)

Syneos Health is a leading fully 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. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

We have 29,000 employees across 110 countries. Work here matters everywhere.

Responsibilities

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Acts as lead for assigned writing projects.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Develops or supports a variety of documents that include, but are not limited to:
  • Clinical study protocols and clinical protocol amendments
  • Clinical study reports
  • Patient narratives
  • Clinical development plans
  • IND submissions and annual reports
  • Integrated summary reports
  • NDA and (e)CTD submissions
  • Investigator brochures
  • Clinical journal manuscripts, clinical journal abstracts, and client presentations
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• Serves as peer reviewer on internal review team providing review comments on draft and final documents.
• Adheres to established regulatory standards, including ICH-E3 guidelines, company SOPs, client standards, and approved templates.
• Performs online clinical literature searches as applicable.
• Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
• Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
• Completes required administrative tasks within the specified timeframes.
• Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

Qualifications

• Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
• Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as familiarity with AMA style guide.
• Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills; team-oriented approach.
• 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.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health at http://www.syneoshealth.com.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its discretion. Equivalent experience, skills, and/or education will also be considered. The Company will determine what constitutes equivalent qualifications. This description is intended to comply with applicable laws and regulations. The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations when appropriate.

Summary

Strong medical writing skills and experience in lead authoring various drug regulatory documents. Ability to lead and work on multiple deliverables in parallel whilst maintaining quality and meeting timelines. Opportunity to work in a global team environment with growth and development opportunities.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Marketing, Public Relations, and Writing/Editing