Principal Medical Writer - US/Canada (fully homebased) in Orpington

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 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. Why? 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.

Job Responsibilities

• Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Completes a variety of documents that may include clinical study protocols and amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; plain language summaries; periodic safety update reports; clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings.
• Adheres to established regulatory standards, including ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved templates, authorship requirements, and style and formatting guides.
• Advises clients and study teams on data presentation and production strategies to ensure that client objectives/expectations are met and quality standards are maintained.
• Leads team document reviews and coordinates quality and editorial reviews.
• Serves as expert peer reviewer for internal team, providing review comments to ensure clarity, accuracy, and relevance.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency.
• Interacts and builds good working relationships with clients, department heads, and team members in data management, biostatistics, regulatory affairs, and medical affairs.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to resolve issues, serving as a key technical SME.
• Mentors and leads less experienced medical writers on complex documents.
• Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.
• Aware of budget specifications for assigned projects, communicating status and changes to medical writing leadership.
• Represents the medical writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding writing projects.
• Completes required administrative tasks within the specified timeframes.

Min/Preferred Education Level Description

Minimum 4 Year / Bachelors Degree in a relevant discipline with relevant writing experience; graduate degree preferred.

Additional Qualifications

• At least 6 years of relevant experience in science, technical, or medical writing.
• Extensive experience working in the biopharmaceutical, device, or contract research organization industry required.
• Advanced understanding of FDA and ICH regulations and guidelines and/or good publication practices required.
• Extensive experience writing relevant document types required.
• Extensive knowledge of English grammar and able to communicate clearly; strong familiarity with AMA Manual of Style.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks, duties, and job responsibilities at its sole discretion. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.