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    • Experience in managing and directing complex medical writing projects required.
    • May serve as backup medical writer.
    • Experience in managing and directing complex medical writing projects required.
    • Proven leadership skills to manage and mentor a team of medical writers.
    • Provide strategic and programme-level leadership across one or more Medical Writing FSP groups, establishing and communicating clear priorities and direction.
    • Experience in managing and directing complex medical writing projects required.
    • Excellent data interpretation and medical writing skills, including grammatical,…
    • The Medical Director works closely with commercial and clinical teams to provide critical medical strategic input into evolving core medical strategy.
    • View all Emergent BioSolutions jobs - London jobs - Medical Director jobs in London
    • Salary Search: Director, Medical Affairs - Remote salaries in London
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    • Develop medico-legal report writing skills.
    • Recent reforms have introduced new fast-track registration pathways for eligible international medical specialists…
    • Excellent writing and content creation skills, with the ability to create engaging and effective content for digital audiences.
    • Prepare high-quality, objective medico-legal reports.
    • Review relevant medical records and clinical information.
    • Conduct face-to-face medico-legal assessments.
    • Strong report writing and communication skills.
    • Deliver CBT therapy to clients referred through the medico-legal process.
  • View similar jobs with this employer
    • Develop medico-legal report writing skills.
    • Recent reforms have introduced new fast-track registration pathways for eligible international medical specialists…
  • View similar jobs with this employer
    • Develop medico-legal report writing skills.
    • Recent reforms have introduced new fast-track registration pathways for eligible international medical specialists…
    • Excellent written and verbal communication, with the ability to convey complex legal issues clearly and concisely to non-legal stakeholders.
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    • Develop medico-legal report writing skills.
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    • Financial/Legal Advice (eg, Will-writing; Lasting Power of Attorney).
    • Project Managers report to the AHUK PMO Manager and will be supported by the wider PMO…
    • Experience in medical education, e-learning or professional examination preparation.
    • Salary: £32,000 per year*.
    • The right to work in the United Kingdom.

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Job Post Details

Program Manager, Regulatory Medical Writing - Client-dedicated FSP - job post

Thermo Fisher Scientific
3.4 out of 5 stars
Remote
Full-time
You must create an Indeed account before continuing to the company website to apply

Job details

Job type

  • Full-time

Shift and schedule

  • Monday to Friday

Full job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as a Program Manager within our Regulatory Medical Writing team where you will make an Impact at the Forefront of Innovation.
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Regulatory Medical Writing Program Manager, you will lead client programs with high visibility among internal and client teams, often requiring a high degree of client engagement and management; manage client relationships and identify and resolve client management issues; manage and ensure the timely delivery and the quality of multiple program documents; develop, monitor, and adapt project plans, client and program-specific processes, timelines, and budgets/forecasting for programs. You will also serve as subject matter expert for assigned programs.

What You’ll Do:

  • Develop project timelines, standards, budgets, forecasts and contract modifications for assigned projects. Serves as liaison with other departments on contract modifications.

  • Assist business development and senior management on securing new business at program levels by developing and making presentations to clients, leading the development and review of proposal texts and budgets, and supporting contract negotiations.

  • Serve as point of contact for risk escalation for assigned programs. Evaluates and appropriately escalates or resolves risks to project quality, budget, or timeline.

  • Ensure compliance with quality processes and requirements for assigned programs both within and between documents within a project. Develops, reviews and manages performance metrics for assigned projects.

  • Provide training for medical writers on processes and technical aspects of program management.

  • May serve as backup medical writer. Duties could include researching, writing and editing clinical study reports and protocols, summarizing data from clinical studies, writing or providing input on complex clinical and scientific documents such as IBs, INDs, and MAAs, and providing senior review of project materials.


Education and Experience Requirements:

  • Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred

  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).

  • Experience in managing and directing complex medical writing projects required

  • 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 sufficient for an individual to meet the requirements of the role.


Knowledge, Skills and Abilities:

  • Solid program management skills to include budgeting, forecasting and resource management

  • Extensive 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 interpersonal, oral and written communication, and presentation skills

  • Excellent negotiation skills

  • Self-motivated and adaptable

  • Excellent judgment; high degree of independence in decision making and problem solving

  • Capable of mentoring and leading junior level staff


Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.

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