Principal/senior Medical Writer

hace 1 semana

Madrid, Madrid, España Syneos Health Clinical A tiempo completo

Description

Principal/Senior Medical Writer
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

  • Serves as medical writing lead on clinical regulatory documents. Creates complete and quality drafts prior to each team review. Meets project deadlines. Produces documents that have few quality control (QC) findings.
  • Coordinates the review of appropriate functions (e.g., QC, source doc approval, formatting, etc.) involved in the document development.
  • Schedules and effectively leads and conduct kickoff meetings and review meetings with the team. Creates agendas and meeting minutes for each meeting.
  • Effectively communicates clinical regulatory document deliverables and writing process to team members. Holds team members accountable to agreedupon project dates.
  • Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate.
  • Successfully and independently manages team to timeline; maintains sponsor awareness of delays, issues, and gaps to effectively manage the timeline and communicates appropriately to sponsor MW manager;

Effectively attends to multiple tasks within overlapping timeframes; builds positive and productive relationships that enable high quality documents to be completed on time.


Qualifications

What we're looking for

  • Bachelor of Science required, with significant relevant writing experience, or Bachelor's degree in English or communications, with significant relevant science experience. Masters or PhD in science discipline preferred with relevant writing experience.
  • Must have 3 to 6+ years relevant industry experience in medical writing in the pharmaceutical and/or healthcare industry.
  • Must have 3+ years experience in experimental design and clinical/preclinical data interpretation.
  • Highlevel content writing experience and experience with all types of clinical publications or clinical regulatory documents required. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience. Working knowledge of statistical concepts and techniques.
  • Expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions.
  • Expert knowledge of Common Technical Document content templates. Working knowledge of current electronic document management systems and information technology.
  • Extensive experience in working with collaborative, crossfunctional teams, including project management experience.

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.

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