Sr Medical Writer Publications - Sponsor Dedicated - Remote Based

Syneos Health/ inVentiv Health Commercial LLC; Nebraska; Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Car allowance

Health benefits

401k match

Employee Stock Purchase Plan

Bonus based on performance

Flexible PTO

Job summary

Syneos Health/ inVentiv Health Commercial LLC is seeking a skilled medical writer to lead the creation and review of clinical writing deliverables across studies, ensuring scientific accuracy and timely delivery.

The role involves coordinating with data management, biostatistics, regulatory affairs, and medical affairs, mentoring junior writers, and maintaining compliance with ICH guidelines and internal SOPs. Some travel may be required.

Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Completes a variety of documents that may include journal manuscripts, abstracts, posters, and presentations for scientific meetings.
• Adheres to established regulatory standards, including ICH E3 guidelines and SOPs, client standards, and templates, on time and on budget.
• Coordinates quality and editorial reviews; leads team document reviews and reviews documents as needed.
• Acts as peer reviewer for internal team to ensure document content, clarity, and format.
• Interacts with clients and colleagues across data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables.
• Identifies issues and provides solutions; mentors staff; contributes to internal materials and process improvements.
• Mentors and leads less experienced medical writers on complex projects as necessary.
• Develops deep expertise on industry topics and regulatory requirements affecting medical writing.
• Aware of budget specifications and communicates status and changes to leadership.
• Completes required administrative tasks within timeframes.
• Performs other duties; minimal travel may be required (<25%).

Job description

Job Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client.
• Completes a variety of documents that may include journal manuscripts, abstracts, posters, and presentations for scientific meetings.
• Adheres to established regulatory standards, including but not limited to ICH E3 guidelines, as well as company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides, when completing medical writing projects on time and on budget.
• Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads team document reviews, and reviews documents as needed.
• Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
• Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables.
• Identifies and proposes solutions to resolve issues, escalating as appropriate. Provides technical support, training, and consultation to department and other company staff. May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities.
• Mentors and leads less experienced medical writers on complex projects, as necessary.
• 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, working within the budgeted hours and communicating status and 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%).

Benefits

Benefits for this position may include a company car or car allowance, health benefits (medical, dental and vision), company match 401k, eligibility to participate in an Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Eligibility for paid sick time may vary depending on where you work.

Salary Range

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

Additional Information

Equivalence in experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.