Single Sponsor Sr Clinical Medical Writer - (fully home based)
Join to apply for the Single Sponsor Sr Clinical Medical Writer - (fully home based) role at Syneos Health.
Get AI-powered advice on this job and more exclusive features.
Senior Medical Writer
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 centers on the customer and the patient. We strive to simplify and streamline our work to make Syneos Health easier to work with and for.
Whether in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to help our customers achieve their goals. We are agile and driven to accelerate therapy delivery because we are passionate about changing lives.
Discover what our 29,000 employees across 110 countries already know:
Why Syneos Health
* We are passionate about developing our people through career development, supportive management, training, peer recognition, and rewards.
* We embrace our Total Self culture, allowing you to be authentic. We are dedicated to taking care of our people.
* We value diversity of thoughts, backgrounds, and perspectives to create a sense of belonging.
Job Responsibilities
* Lead assigned writing projects.
* Manage medical writing activities related to studies, coordinating across departments with minimal supervision.
* Develop or support various documents including clinical protocols, reports, narratives, development plans, submissions, summaries, manuscripts, and presentations.
* Identify and resolve issues during the writing process, escalating as needed.
* Review statistical analysis plans and specifications for content, grammar, and consistency.
* Collaborate with data management, biostatistics, regulatory, and medical affairs teams.
* Serve as peer reviewer on internal review teams.
* Adhere to regulatory standards such as ICH guidelines, SOPs, and client standards.
* Perform literature searches as applicable.
* Stay informed about industry practices and regulatory requirements.
* Manage project budgets and communicate changes.
* Complete administrative tasks timely and perform other duties as assigned.
Qualifications
* Bachelor's degree in Science or Arts with relevant writing and scientific/medical knowledge.
* Experience as a Senior Medical Writer in CRO or Pharma, with knowledge of FDA, ICH, and AMA style.
* Independence, effective presentation, proofreading, interpersonal, and leadership skills.
* Proficiency in Word, Excel, PowerPoint, email, and internet.
* Familiarity with clinical research principles and data interpretation.
* Experience in writing clinical and submission-ready documents.
* Experience in Oncology or Autoimmune diseases preferred.
Additional Information
Tasks and responsibilities are not exhaustive. The company may assign other duties as needed. Qualifications may vary if experience or skills are equivalent. Nothing herein creates an employment contract. The company complies with applicable legislation, including the EU Equality Directive and the Americans with Disabilities Act.
Job Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Business Development and Sales
* Industries: Biotechnology, Pharmaceutical Manufacturing, Research Services
#J-18808-Ljbffr