Mgr, Medical Writing Lisboa

Overview

Mgr, Medical Writing role at Syneos Health. 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 places the customer and the patient at the center of everything 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.

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. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we create a place where everyone feels like they belong.

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
  - alone medical writing projects) as needed.
• 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 maintains relationships with internal and external customers.
• Forms, maintains and leads productive
  - 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
  - related duties as assigned. Minimal travel may be required (up to 25%).

Qualifications

• 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; familiarity with FDA and ICH regulations and guidelines.
• Knowledge of principles of clinical research; excellent communication skills.
• Knowledge of FDA, EU, ICH regulations and guidelines and ISO standards; excellent communication skills.
• Effective presentation, interpersonal, and leadership skills with a
  - oriented approach.
• Strong Microsoft Office Suite skills.

Additional Information

The Company is an equal opportunity employer. Reasonable accommodations will be provided during the recruitment and employment process as required by law. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign additional tasks as needed. This description reflects the current job and may be revised, with or without notice.