Principal Medical Writer

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Jan 08, 2022
Ref
R-152667
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Contract
Job Description

Please note that CSL offers flexible agile work policies – remote working available

The Principal Medical Writer is responsible to determine and drive the medical writing strategy for one or more therapeutic areas.

Responsibilities Include:
• Accountable for the efficient preparation and delivery of high-quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program.
• Leads cross-functional teams to develop a messaging strategy across a program of work (e.g., building a clinical submission).
• Coordinates and builds functionally aligned, consistent information and messages across all individual documents within a clinical program, including clinical development plans, study-level documents and program-level deliverables (e.g., regulatory submissions and primary publications).
• Understands where all intended messages will be located across individual documents within a clinical program, and ensures alignment of messages across documents.
• Contributes to forecasting, budgeting, and resource planning and allocation within assigned therapeutic area.
• Leads the development and maintenance of medical writing SOPs and best practices.

Qualifications:
• Bachelors degree in pharmacy, biological sciences or related disciplines is essential.
• Graduate qualifications desired
• 8-10 years' medical writing experience within the biopharmaceutical industry or a contract research organization.
• A minimum of 3 years in a supervisory role is preferred.
• A comprehensive understanding of the clinical development process, including the documents that are required at each stage; experience with submissions in Common Technical Document (CTD) format preferred.
• A comprehensive understanding of medical writing processes, standards and issues.
• Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
• Demonstrated track record in cross-functional, multicultural and international clinical trial teams.

About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.

Do work that matters at CSL Behring!