Medical Director

Cycle Pharmaceuticals; Cambridge; Hybrid; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Collaborative environment

Performance based bonus

Growth opportunities

Company pension scheme

Private Health Insurance

Life and Critical Illness Insurance

Regular team events

Agile working environment

Job summary

Cycle Pharmaceuticals is seeking an experienced medical writer to lead creation of pivotal clinical and regulatory documents across late-stage programmes, with ownership from Phase 3 protocols to post-approval studies. The role combines hands-on authoring with oversight of external writers, ensuring submissions are robust, clear and submission-ready.

You will collaborate across Clinical Development, Regulatory Affairs, Clinical Operations and Medical Affairs to consolidate complex data into

Qualifications

• Lead authorship of Phase 3 protocols and clinical study reports.
• Experience authoring NDA/BLA/MAA CTD Module 2 clinical summaries and integrated summaries is desirable.
• Experience with post-approval studies (e.g., post-marketing, open-label extensions, registries).
• Strong knowledge of ICH guidelines (E3/E6/E9/M4), FDA expectations and eCTD structure.
• Experience managing outsourced writing providers or freelancers.
• EMWA/AMWA certification is desirable; familiarity with document management systems such as Veeva Vault is a plus.
• Ability to interpret and present clinical and statistical data accurately.

Responsibilities

• Lead the authoring of pivotal Phase 3 clinical documents (protocols, amendments, ICFs, abstracts, CSRs).
• Prepare clinical content for FDA meetings and marketing applications (briefing packs, regulatory responses, CTD summaries).
• Collaborate with Clinical Operations and CROs to ensure data support is clear and accurate.
• Lead authoring for Phase 4 and post-approval studies (PMPs, open-label extensions, registries).
• Prepare post-approval submissions, labelling supplements, annual reports, and PSRs; support Pharmacovigilance with PSRs.
• Develop study materials and plain language summaries; contribute to manuscripts and congress materials.
• Lead ClinicalTrials.gov registration and results disclosure; ensure consistency and separation from promotional activities.
• Collaborate with Regulatory to maintain writing standards, templates, style guides, QC processes; ensure inspection readiness.
• Oversee document planning, timelines, reviews, and external writer management; forecast resource needs.
• Contribute to budgeting, planning, prioritisation; stay updated on regulatory guidance; mentor junior staff.

Skills

Attention to detail

Project management

Stakeholder management

Communication skills

Education

Life sciences degree

PhD or advanced degree preferred

Tools

Veeva Vault

Job description

Position Summary: This full-time position is within the Research and Development department in our Cambridge office on a hybrid basis (minimum 3 days in the office).

At Cycle Pharma, we’re looking for an experienced medical writer to lead the development of clinical and regulatory documents across our late-stage and post-approval programmes, helping bring important treatments to patients with rare and complex diseases.

You’ll take ownership of key documents across the clinical development journey, from Phase 3 study protocols and clinical study reports through to marketing applications, as well as Phase 4 and post-approval studies supporting our marketed products. Combining hands‑on authoring with oversight of external writing partners, you’ll play a pivotal role in ensuring our submissions are scientifically robust, clearly communicated and consistently delivered to the highest standards.

Working across programmes in metabolic disease, neurology, immunology and oncology, you’ll collaborate closely with Clinical Development, Regulatory Affairs, Clinical Operations, Pharmacovigilance and Medical Affairs. You’ll bring complex clinical data and regulatory requirements together into clear, accurate and compelling documents that support sound decision-making and successful regulatory submissions.

If you’re a detail-oriented medical writer who combines scientific expertise with excellent communication skills, enjoys collaborating across multidisciplinary teams and wants to make a meaningful contribution to the development of treatments for patients with significant unmet medical needs, we’d love to hear from you.

Our Company

At Cycle, we believe that Every Single Patient Matters. This is at the heart of why we work and were looking for people to join our team who share our vision. We know that life-changing treatments need life‑improving product support to match, because when you put the two together, great things can happen.

Our growing portfolio now covers oncology, haematology, neurology and rare metabolic genetic conditions where we improve existing drugs, repurpose them for new uses and bring generics back to market. Using cutting‑edge drug delivery technologies, we enhance the efficiency of treatments, offering patients greater freedom and choice.

Headquartered in Cambridge, UK, with a significant US presence, Cycle has scaled rapidly and was named one of the UK’s fastest‑growing private companies by The Sunday Times (Sunday Times 100 2024 & Sunday Times 100 Tech 2025). If you want to know more about what we do then, why not check out our website and take a look at some of our patient stories: Patient Stories – Cycle Pharma

What you’ll be doing in this role:

• Lead the authoring of pivotal Phase 3 clinical documents, including protocols, amendments, informed consent forms, Investigator’s Brochure updates and final clinical study reports.
• Own the preparation of clinical content for FDA meetings and marketing applications, including briefing packages, responses to regulatory questions, CTD Module 2.5 and 2.7 summaries, and integrated summaries of efficacy and safety.
• Collaborate with Clinical Operations and CRO’s to ensure data support is clear, accurate and consistent.
• Lead the authoring of protocols and reports for Phase 4 and post-approval studies, including post-marketing requirement and commitment studies, open‑label extensions, registries and observational studies.
• Prepare clinical content for post‑approval submissions, labelling supplements, annual reports and post‑marketing study reports, and support Pharmacovigilance with periodic safety reports where required.
• Prepare data monitoring and steering committee materials, patient‑facing study information and plain language summaries, and contribute to manuscripts and congress materials in collaboration with relevant teams.
• Lead clinical trial registration and results disclosure on ClinicalTrials.gov, ensuring consistency of data and key messages across protocols, reports, submissions and publications, while maintaining appropriate separation from promotional activities.
• Collaborate with Regulatory to establish and maintain writing standards, templates, style guides and quality control processes aligned with relevant regulatory guidance, including ICH E3 and M11, ensuring documents are accurate, inspection‑ready and appropriately archived.
• Oversee document planning, timelines, review cycles and comment resolution, while forecasting medical writing resource needs and selecting and managing external writing providers.
• Contribute to departmental budgeting, operational planning and prioritisation; maintain awareness of evolving regulatory and industry guidance; drive process improvements; and support the development of future direct reports and contract writers.

The following skills and experience will be important in helping to set you up to succeed in this role:

• Degree in life sciences or a related discipline, PhD or other advanced degree preferred.
• Extensive experience in clinical and regulatory medical writing within the pharmaceutical, biotechnology or CRO industry, with lead authorship of Phase 3 protocols and clinical study reports.
• Experience authoring clinical documents for an NDA, BLA or MAA, including CTD Module 2 clinical summaries and integrated summaries (strongly preferred).
• Experience writing protocols and reports for post‑approval studies, such as post-marketing requirement studies, open‑label extensions, registries or observational studies.
• Experience with clinical trial disclosure requirements, including ClinicalTrials.gov results posting is desirable.
• Strong working knowledge of ICH guidelines (including E3, E6, E9 and M4), FDA expectations and eCTD structure.
• Ability to interpret and present clinical and statistical data accurately.
• Experience managing outsourced writing providers or freelance writers.
• Membership or certification with EMWA or AMWA (desirable); experience with document management systems such as Veeva Vault (desirable).
• Excellent attention to detail, project management and stakeholder management skills, with the ability to influence across disciplines without direct authority.

What can we offer to you:

In addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will enjoy all the benefits that brings:

• Competitive salary based on experience
• A collaborative high performing work environment
• Performance based bonus
• Opportunity to join a fast growing and ambitious business
• Company pension scheme
• 100% employer paid membership for Private Health Insurance
• Life and Critical Illness Insurance
• Regular team building events and an agile working environment

Diversity and Inclusion statement:

At Cycle Pharmaceuticals, we are committed to creating an inclusive, respectful, positive and diverse workplace. We do not discriminate on the basis of race, colour, religion, gender, age, disability, or any other protected characteristic. We actively support and embrace diversity, and we are working to build a team that reflects a wide range of backgrounds and perspectives.

We value your unique contributions and encourage you to join us in shaping a more inclusive future. If you require any reasonable adjustments - whether during the application process or in the workplace - we will be happy to support your needs. At Cycle, equality, inclusion, and respect are at the core of everything we do. We fully comply with all applicable employment laws, including those related to non-discrimination, work authorization, and employment eligibility verification.