Mgr Med Writing

hace 2 semanas

Madrid, Madrid, España Thermo Fisher Scientific A tiempo completo
We are vital links between an idea for a new medicine and the people who need it.

We are the people of PPD clinical research services - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health.

You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.


This position supervises the activities of the Medical Writers and may coordinate medical writing services across locations within the United States.

The Manager, Medical Writing uses clinical knowledge to assist in the written interpretation of clinical data and to guide others in their presentation of clinical data.

The Manager, Medical Writing also writes and coordinates other documents for submission to regulatory agencies, including IND, NDA, and CTD items.


Essential Functions:

  • Supervises Medical Writers.
  • Provide shortterm and longterm resource planning in order to assign projects to appropriate and available staff. Holds regularly scheduled meetings with staff and provide updates to senior management. Review and approve time sheets. Assist staff to forecast project related costs and timelines for completion. Hires and evaluates employees. Recommends salary levels and promotions
  • Supervises the preparation of Medical Writing deliverables. Organizes processes for completion of projects within established timelines. Evaluate timeliness and quality of deliverables and provides updates to senior management. Acts as resource for questions relating to study design, adverse event reporting, and statistical analyses. Assists writers in presentation and interpretation of data. Performs senior review to ensure overall adherence to departmental standards. Write and review group SOP and WPD. Evaluates compliance with SOP/WPD on an ongoing basis. Stays updated on the guidelines and requirements of the ICH, FDA and other relevant agencies.
  • Develops and maintains training programs for Medical Writing. Ensures that all writers are adequately trained.
  • Uses clinical knowledge to assist in the written interpretation of clinical data and to guide others in their presentation of clinical data.

Education and Experience:

  • BS/BA (scientific discipline preferred) with 6 years relevant experience or Advanced degree with 3 years relevant experience
  • 2 years relevant experience in medical writing, preferably within the pharmaceutical industry
  • 1 year supervisory/management experience or equivalent combination of education, training, and experience that provides the individual with the required

Knowledge, Skills and Abilities:

  • Must possess the ability to supervise, evaluate, and mentor departmental personnel
  • Must possess the ability to delegate tasks and facilitate completion of assignments
  • Must possess evidence of strong management skills, including the ability to create and modify budgets, project timelines, allocate resources, and forecast departmental workload
  • Must possess welldeveloped presentations skills for use in client presentations
  • Must demonstrate innovation in developing new ideas related to Medical Writing, including process improvements
  • Must possess excellent medical writing skills, including excellent grammatical, editorial, and proofreading skills, and the ability to effectively interpret and present extremely complex data
General Office Based

  • PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
Below is listed the working environment/requirements for this role:
_

  • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
  • Able to work upright and stationary for typical working hours.
  • Ability to use and learn standard office equipment and technology with proficiency.
  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

What we offer


At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team.

We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.


As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees.

We have a flexible working culture, where PPD clinical research services truly value a work-life balance.

We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.

We are a global organization but with a local feel.

Our 4i Values:

**Integrity - Innovation - Intensity - I

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