Principal 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 right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

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

As a Principal Medical Writer, you will serve as the primary author by writing and providing input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.

You will be a part of a team who is dedicated to its people and fosters a supportive, collaborative culture based on trust, flexibility and work-life balance. You would be able to consider the work setting where you would be most productive, able to choose being entirely remote based or work part-time of at least 25-30hours per week.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees.

Summarized Purpose:
Essential Functions:

- Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
- Researches, writes, edits complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
- Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes.
- May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
- Represents the department at project launch meetings, review meetings, and project team meetings.

Education and Experience:

- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
- Experience within regulatory medical writing (comparable to 8+ 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:

- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- Excellent project management skills
- Advanced interpersonal, oral and written communication, and presentation skills
- Excellent negotiation skills
- Excellent judgment; high degree of independence in decision making and problem solving
- Ability to mentor and lead junior level staff

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.

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