Job Description

Description Manager, Publishing Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health

• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• 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

• Responsible for delivery of high quality regulatory published outputs to the Operational Functional teams.
• Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
• Acts as a representative of the publishing department with other Syneos departments.
• Develop, review and update processes and best practice to provide and maintain clear standardized process guides.
• Drive quality and compliance with regular operational status reviews, and operational issue resolution and risk mitigation.
• Performs QC tasks within the electronic publishing system and QC of the published output, including internal QC and QC of client documentation.
• If needed, creates, keys, and assembles client deliverable documents and submissions using standard word processing or publishing systems and utilities (Extedo's eCTDManager and eSUBmanager, CoreDossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat and others).
• Establish clear communication channels with Client contacts and operational teams.
• Acts as the central point of escalation for issues and risks which require decision-making or mitigation steps at the program level.
• Drives performance management, periodic performance reviews and appraisals with timely support and guidance including identification of training or coaching needs and appropriate providers.
• Directly review major submissions from a publishing regulatory compliance, strategy and technical perspective in conjunction with project leads.
• Prepares applications (INDs, NDAs, ANDAs, DMFs, variations, routine reports, renewals etc.) for submission to global regulatory authorities.
• Able to prioritize and multi-task a number of projects.

Qualifications
What we're looking for

• BA/BS with preference given to a science degree.
• Experience of operational team leadership and project management.
• Broad functional understanding of pharmaceutical sciences and a clear understanding of the drug development or manufacturing/improvement processes. Knowledge of medical/scientific terminology, ICH guidelines and regulations and procedures preferred. Knowledge of submission requirements of various markets such as USFDA, EMA etc. an advantage.
• Excellent communication skills (both written and verbal), with strong technical/regulatory writing ability.
• Proven ability to prioritize and multi-task a number of projects.
• Strong communication skills.
• Broad exposure to global Health Authorities' perspectives and risk posture.
• Extensive quality management skills and experience.
• Good working knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel.
• Good experience with relevant software such as Extedo's eCTDManager and eSUBmanager, CoreDossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat, Documentum, , Ezsubs, IMS Word for Windows, and Access.

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. 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 . 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 contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. 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.