Medical Writing Manager(Regulatory Experience - Madrid, España - Syneos Health Clinical

Syneos Health Clinical

Empresa verificada

Madrid, España

hace 3 semanas

Publicado por:

Isabel García

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Descripción

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

Projectspecific 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 (fullservice clinical development projects and standalone 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 crossfunctional 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 workrelated 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 teamoriented 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 challeng