Team Lead, Medical Writing

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I– IV) and non– interventional studies. Our offices are located in France, UK, US, Belgium, Czech Republic, Switzerland, Denmark, Romania, and India.

The CRO occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials in complex disease areas including oncology, immuno– oncology, and cell therapy, but also as a developer of its own technologies for managing clinical data. This is a very exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data.

We are currently looking for an enthusiastic and talented Team Lead, Medical Writing. This role can be home– based in the UK or EU where we have the ability to hire.

Overview:

We are seeking a highly skilled and experienced Medical Writer Team Leader to oversee our team of medical writers. The ideal candidate will possess strong leadership abilities, exceptional medical writing skills, and a comprehensive understanding of the regulatory framework. This role involves managing a team of approximately 13 medical writers, ensuring high– quality content creation, and maintaining compliance with regulatory standards.

Responsibilities:

■ Team Leadership:

Provide leadership, guidance, and mentorship to a team of medical writers.

Set clear objectives, goals, and priorities for the team and individuals.

Provide regular feedback to team members.

Foster a collaborative and supportive work environment.

■ Content Development:

Oversee the creation of various medical writing content, including but not limited to regulatory documents (protocols and amendments, study reports, Investigator’s Brochures, clinical submission documents, briefing documents, lay summaries, pediatric plans, Q&A documents) as well as scientific publications (including presentations, abstracts and posters).

Ensure accuracy, scientific rigor, and adherence to company guidelines and industry standards in all written materials.

Review and edit team members’ work for quality, clarity, and compliance.

■ Project Management:

Coordinate project timelines, milestones, and deliverables.

Collaborate with cross– functional teams, including clinical operations, statistics and programming, data management, PV, regulatory affairs, medical monitors, etc. to align on content requirements and timelines.

Manage multiple projects simultaneously, ensuring timely completion and adherence to deadlines and Sponsor contracts.

■ Regulatory Compliance:

Stay updated on regulatory guidelines and industry best practices to ensure compliance in all medical writing activities.

Review documents for regulatory submissions to ensure adherence to guidelines.

■ Training and Development:

Identify training needs and opportunities for professional development within the team.

Conduct training sessions and workshops to enhance the team’s writing skills and knowledge of medical and scientific concepts.

Qualifications:

Advanced degree (Ph.D., M.D., or equivalent) in life sciences, pharmacy, medicine, or a related field.

Proven experience (>7 years) in medical writing within the pharmaceutical, biotech, or healthcare industries.

Strong leadership and managerial skills with the ability to lead and motivate a team.

Excellent written and verbal communication skills with a keen eye for detail.

In– depth knowledge of medical terminology, clinical research, and regulatory requirements.

Preferred Skills:

Previous experience in another Contract Research Organization (CRO).

Familiarity with different therapeutic areas, including oncology

Medical device experience

For more information on Aixial Group Recruitment and consideration for other opportunities, please review the recruitment statement on our careers page – https://www.aixialgroup.com/join– us/

Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Aixial Group HR or Talent Acquisition Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.