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PPD

Med Writer

PPD's mission is to improve health.It starts as an idea to find a cure. It becomes a life saved. All in-between,it's you! We know that meaningful results not only require the rightapproach, but also the right people. We invite you to re-imagine healthpromoting protocols with us, working alongside our talented, bright andenergetic teams.

We are passionate about being dataand technically agile and driving enhanced value for our clients and patients.Determined to improve patient health, we help PPD provide industry-leadingstatistical, programming and clinical pharmacology contributions through globaldelivery, consistent quality adherence and scientific insight.

As a MedicalWriter,you will serve as the primary author by writing andproviding input on routine documents such as clinical study reports and studyprotocols and summarizes data from clinical studies.

At PPD we hire the best, developourselves and each other, and recognize the power of being one team. We offercontinued career advancement opportunities, award winning training and benefitsfocused on the health and well being of our employees.

Summarized Purpose:

Provides high-quality medical andscientific writing from planning and coordination through delivery of finaldrafts to internal and external clients. Demonstrates subject matter andtherapeutic area expertise. May assist program manager. Collaborates withinternal and external clients, supporting and enabling effective and efficientcommunication that results in operational excellence.

Essential Functions:
  • Serves as primary authorwho writes and provides input on routine documents such as clinical studyreports and studyprotocols andsummarizes data from clinicalstudies.
  • Researches, writes,edits complex clinical and scientific and program level documents, includingIBs, INDs, and MAAs.
  • Reviews routinedocuments prepared by junior team members. May provide training and mentorshipfor junior writers and program managers on document preparation, the use ofsoftware for document development, document types, regulatory requirements, andtherapeutic area knowledge.
  • Ensures compliance withquality processes and requirements for assigned documents. Provides input onand independently develops best practices, methods and techniques for achievingoptimal results, including various client-specific processes.
  • May assist in programmanagement activities. Identifies and resolves out-of-scope activities. Dutiescould include developing timelines, budgets, forecasts and contractmodifications.
  • Represents thedepartment at project launch meetings, review meetings, and project teammeetings.


Job Qualification:

Education and Experience:

Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).

Experience working in the pharmaceutical/CRO industry preferred

Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered enough for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:
  • Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
  • Strong project management skills
  • Excellent interpersonal skills including problem solving
  • Strong negotiation skills
  • Excellent oral and written communication skills with strong presentation skills
  • Significant knowledge of global, regional, national and other document development guidelines
  • In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
  • Great judgment and decision-making skills
  • Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)


Working Environment:

PPD values the health and well being 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.

May require travel. (Recruiter will provide more details.)

PPD Defining Principles:

-We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing - We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you.

Diversity Statement

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

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