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Role Filled
Senior Regulatory Writer
Healthcare Communications
Medical Writer Scientific Dir
Med Comms
Remote
Up to £55k D.O.E
Role Overview
As a Senior Regulatory Medical Writer, you will play a critical role in ensuring the successful development and submission of regulatory documents to global health authorities.
You will collaborate closely with cross-functional teams, including clinical development, regulatory affairs, and scientific experts, to create accurate, concise, and compelling regulatory submissions.
Your expertise in medical writing and regulatory guidelines will contribute directly to our mission
of delivering safe and effective treatments to patients worldwide.
Company Information
This agency is home to the world’s most celebrated and awarded med comms agencies, united by a healthy obsession with creating exceptional medical communications for their clients.
Their people are the beating heart of the organisation, and through the positive culture they champion, their teams create communications that not only have a positive impact for our clients, but also impact on the world around us.
Role Requirements
Develop high-quality regulatory documents, including clinical study reports (CSRs), clinical summaries, safety narratives, investigator brochures, protocols, and sections of regulatory submissions
Collaborate with cross-functional teams to gather necessary information and data to support regulatory submissions.
Ensure compliance with regulatory guidelines, industry standards, and internal processes for document preparation and submission.
Conduct thorough research and analysis to generate well-structured and scientifically accurate content.
Review and edit documents to ensure clarity, consistency, and adherence to company standards.
Keep abreast of evolving regulatory requirements and guidelines to maintain a deep understanding of the global regulatory landscape.
Mentor and provide guidance to junior medical writers, fostering their professional growth and development.
Person Specifications
Degree in life sciences, pharmacy, or a related field.
Minimum of 3 years of experience in regulatory medical writing within the pharmaceutical, biotechnology, or medical device industry.
Strong understanding of regulatory guidelines (e.g., FDA, EMA, ICH) and industry best practices.
Exceptional written and verbal communication skills, with the ability to translate complex scientific information into clear and concise language.
Detail-oriented approach, with excellent organizational and time management abilities.
Proficiency in document management systems and other relevant software (e.g., MS Office, Adobe Acrobat).
Demonstrated ability to work effectively in a fast-paced, deadline-driven environment, managing multiple projects simultaneously.
Package
Uncapped paid time off
Retail and gym discounts
Great training and development
Life assurance
Pension
Employee assistance programme
Private healthcare
Headspace and MYNDUP – a mental health wellness programme
Cycle to work scheme
Long Service Award
Season Ticket Loan
Flexible working
Locations
Alabama
Alaska
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Nebraska
Nevada
New Hampshire
New Jersey
Previous Listing
Date Updated
29 Nov 2023
Job reference
71674
Categories
Full Time
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