Mgr, Publishing

4 weeks ago


Remote, Canada Syneos Health Clinical Full time

**Description**

**Manager, Publishing**

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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.

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 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**
- Line management responsibility for direct publishing staff members. Recommends courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
- Reviews publishing work products for completeness, accuracy, and overall quality; assumes responsibility for output quality.
- Responsibility for all components of document compilation and publishing, as necessary.
- Assists with the preparation of budgets and timelines for publishing activities for full-service clinical development projects and for stand-alone publishing projects as needed.
- Reviews medical writing plans, statistical analysis plans and table/figure/listing specifications for publishing format, and consistency, as necessary.
- May assist in review, and revision of Standard Operating Procedures (SOPs), as appropriate.
- May participate in Medical Writing department management team activities for projects requiring publishing support, including planning, strategy, budget, or development activities, as requested
- May serve as Project Lead on complex publishing projects or stand-alone publishing output.
- May provides technical support and expertise for other types of documents as necessary.

**Qualifications**

**What we’re looking for**
- Bachelor’s degree required
- Significant pharmaceutical/medical device or CRO experience required.
- Management experience preferred, including senior-level or team-lead experience in electronic publishing within the pharmaceutical, medical device or contract research organization industries.
- Excellent grammatical and communication skills, both written and oral.
- Ability to lead a project team and to keep others informed of the progress and status of writing projects. Adaptable to changes in work duties, responsibilities, and requirements.
- Knowledge of FDA and EU requirements, ICH regulations and ISO standards as applicable to regulatory documents preferred.
- Advanced Microsoft Office Suite skills required.

**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, duties, and job responsibilities. Equivalent 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. Further, nothing contained herein should be construed to create an employment con