Medical Writer

Blackfield Associates; Birmingham; Remote; GBP 40,000 - 60,000; Full time

Job summary

A leading consultancy firm is seeking an experienced Regulatory Medical Writer to support the preparation and submission of Marketing Authorisation Applications for generic pharmaceutical products. You will be responsible for authoring overviews, supporting submissions, and collaborating with cross-functional teams. Candidates should have at least 3 years of regulatory writing experience and a degree in a relevant field. This is a full-time, permanent remote position.

Qualifications

• 3+ years of experience in regulatory medical writing.
• Strong understanding of bioequivalence and biowaivers.
• Proven experience with CTD Modules 2.4 and 2.5.

Responsibilities

• Author clinical and non-clinical overviews using scientific literature.
• Support regulatory submissions like variations and renewals.
• Compile bibliographies for CTD Modules 4 and 5.

Skills

Regulatory writing

Communication skills

Attention to detail

Client-focused mindset

Education

Degree in Life Sciences, Pharmacy, or Medicine

Tools

Microsoft Office

Reference management tools

Job description

Are you a skilled Regulatory Medical Writer looking to make an impact in a fast-growing consultancy environment?

Blackfield Associates are working with a growing consultancy, who due to new clients have a requirement for a Regulatory Medical Writer.

This is your opportunity to join a dynamic team supporting the preparation and submission of Marketing Authorisation Applications for generic pharmaceutical products.

As Regulatory Medical Writer, you will be responsible for:

• Author clinical and non-clinical overviews and summaries using published literature and bioequivalence data.
• Support regulatory submissions including variations, renewals, and clinical updates.
• Compile bibliographies for CTD Modules 4 and 5.
• Interpret complex scientific data and present it clearly and accurately.
• Ensure compliance with global regulatory guidelines (ICH, GCP, FDA, EMA).
• Collaborate with subject matter experts and cross-functional teams.
• Manage timelines, document versions, and feedback cycles.
• Engage with clients to understand their product strategy and regulatory pathway.

To be considered for the role, you will have the following skills and experience:

• Degree in Life Sciences, Pharmacy, Medicine, or related field (Advanced degree preferred).
• 3+ years of experience in regulatory medical writing.
• Strong understanding of bioequivalence, biowaivers, and bridging studies.
• Proven experience with Modules 2.4 and 2.5 and supporting bibliographies.
• Excellent communication skills and attention to detail.
• Proficiency in Microsoft Office and reference management tools (e.g., EndNote).
• Ability to manage multiple projects and meet deadlines.
• A pragmatic, client-focused mindset.

This is a full time, permeant position. Working remotely.

Applicants must have the full Right to Work in the UK, as our client are unable to sponsor.