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Sr Medical Writer Publications - Sponsor Dedicated - Remote Based

Syneos Health/ inVentiv Health Commercial LLC

Overview

Sr Medical Writer Publications - Sponsor Dedicated - Remote Based. Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate 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 make Syneos Health easier to work with and 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 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.

Discover what our 29,000 employees across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health
  • 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 unites us globally, and we are dedicated to taking care of our people.
  • We continuously build the company we want to work for and our customers want to work with. By bringing together diversity of thoughts, backgrounds, cultures, and perspectives we create a place where everyone belongs.
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 client comments.
  • 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, as well as company standard operating procedures, client standards and 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 heads, 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 and Additional Information

The benefits for this position may include a company car or car allowance, health benefits to include medical, dental and vision, 401k with company match, eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible PTO and sick time. Paid sick time eligibility may vary by location in accordance with state and municipal requirements. Syneos complies with applicable federal, state, and municipal paid sick time requirements.

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

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.

Additional Information

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 and duties. Equivalent experience, skills, and/or education will be considered; qualifications of incumbents may differ from those listed. The Company will determine what constitutes equivalent qualifications. Nothing herein should be construed to create an employment contract. Any language is intended to comply with obligations of the country in which it operates, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations when appropriate.

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Vacancy posted 4 days ago
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