Medical Writing Manager(Regulatory experience required)

Employer
Syneos Health
Location
Spain; Homeworking
Salary
Competitive
Start date
10 Jan 2023
Closing date
9 Feb 2023

View more

Discipline
Medical Communications, Medical Writing
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

Description

Manager, Medical Writing

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
• Project-specific management responsibilities for medical writing 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 and edits departmental work products for completeness, accuracy, and overall quality; assumes responsibility for quality of departmental work products.
• Ensures adherence to Sponsor objectives and that quality standards are maintained.
• Supports the company’s MW leadership team in the planning, development and implementation of document development strategies and development and presentation of quarterly business updates.
• Assists with the preparation of budgets and timelines for medical writing activities (full-service clinical development projects and stand-alone medical writing projects) as needed.
• Assists with budgeting, revenue, invoicing, and forecasting as requested.
• Assists with budgeting, revenue, invoicing, and forecasting as requested.
• Contributes to departmental metrics by assisting in the tracking, maintaining and reviewing project metrics.
• Supports business development by assisting with proposal and costing development as well as bid defenses and customer meetings.
• Builds and maintain relationships with internal and external customers.
• Forms, maintains and leads productive cross-functional working teams, including addressing issues that arise.
• Reviews performance of medical writing personnel (direct reports).
• Develops and maintains departmental SOPs and templates and acts as resource for implementation.
• Participates in the planning, writing, and assembly of medical writing deliverables, as needed.
• Performs senior reviews of medical writing deliverables, as well as reviews of statistical analysis plans and table/figure/listing.
• Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

Qualifications

What we’re looking for
• Bachelor’s degree required with relevant scientific and/or medical knowledge and expertise.
• Experience in medical writing with progressive management experience and experience in a contract research organization or pharmaceutical/medical device company.
• Management experience preferred.
• Extensive knowledge of English grammar required. , FDA and ICH regulations and guidelines.
• Knowledge of principles of clinical research excellent communication skills.
• Knowledge of principles of clinical research, including FDA, EU, ICH regulations and guidelines and ISO standards; excellent communication skills.
• Effective presentation, interpersonal, and leadership skills with a team-oriented approach.
• Strong Microsoft Office Suite skills.

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 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.

Company

Syneos-header

Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 23,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life® visit syneoshealth.com.

 

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Find Us
Website
Mini-site
Syneos Health
Telephone
+1 919 844 7100
Location
Corporate Headquarters
3201 Beechleaf Court
Suite 600
Morrisville
Raleigh
27560
GB
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