M

MMS

Regulatory compliance and data solutions provider

Senior Medical Writer

Full-TimeUpdated on 10/15/2026
No salary listed
Mid, Senior
Bachelor's, Master's, PhD
Mexico City, CDMX, Mexico
RemoteRemote work is available from any location in Mexico.
Content & WritingTechnical Writing

About the job

Requirements
  • At least 3 years of previous experience in the pharmaceutical industry.
  • At least 3–5 years of industry regulatory writing and clinical medical writing experience.
  • Substantial clinical study protocol experience as lead author.
  • Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
  • Understanding of clinical data.
  • Expert proficiency in Microsoft Word, Excel, PowerPoint, and related word processing tools.
Responsibilities
  • Critically evaluate, analyze, and interpret medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor, and absence of bias.
  • Write and edit clinical development documents, including clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Modules 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials, and publications to medical journals.
  • Complete writing assignments in a timely manner and maintain their timelines and workflow.
  • Provide internal and external customer service.
  • Use appropriate writing styles for various regulatory documents and apply client templates and style guides.
  • Interact directly and independently with clients to coordinate all facets of projects.
  • Contribute substantially to, or manage, the production of interpretive guides.
  • Take ownership of assignments and proactively consult project team members and other department representatives for information or guidance as necessary.
  • Mentor medical writers and other project team members involved in the writing process.
Desired Qualifications
  • Experience with regulatory submissions, including clinical study reports presented to regulatory authorities.
  • A strong understanding of federal regulations, Good Clinical Practices, and International Council for Harmonisation guidelines.
  • Experience with orphan drug designations and PSP/PIPs.

About the company

MMS Holdings is a global contract research organization (CRO) focused on regulatory compliance and data-driven solutions for pharmaceutical and biotech sponsors. It delivers services such as regulatory submissions, clinical trial management, data analytics, and medical writing through a service-based model that relies on established processes and experienced advisors. Its work is contract-based, often long-term, aimed at helping clients meet regulatory requirements, run trials efficiently, and advance therapies under FDA guidance. The company differentiates itself with a science-first approach, a strong track record (97% client satisfaction), and involvement in complex areas like enabling MDMA-assisted therapy research, underscoring a commitment to high-quality, compliant outcomes for sponsors globally.

Company Size

1,001-5,000

Company Stage

N/A

Total Funding

N/A

Headquarters

Canton, Michigan

Founded

2006

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Simplify Jobs

Simplify's Take

What believers are saying

  • 2025-02-22 Exploristics expanded Europe reach and advanced trial-design analytics.
  • 2026-03-17 Datacise and modern EDC workflows show active productized service demand.
  • 2026-06-08 BIO presence suggests stronger West Coast biotech pipeline and sponsor access.

What critics are saying

  • 2026 headcount fell to 948 from 1,051 in 2023, signaling slower scaling.
  • Exploristics integration risks product disruption and cultural churn through 2026.
  • Boutique CROs and large peers attack MMS's same high-margin biometrics and submission work.

What makes MMS unique

  • 2025-02-22 Exploristics added KerusCloud, deepening MMS biostatistics and simulation design.
  • 2026-05-12 Ben Dudley became president, strengthening global commercial and regulatory execution.
  • MMS pairs regulatory submissions with data science, a rare CRO combination for sponsors.

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Benefits

Remote Work Options

Growth & Insights and Company News

Headcount

6 month growth

19%

1 year growth

21%

2 year growth

21%
MMS Holdings
Sep 29th, 2026
MMS shortlisted for Best CRO - Specialist provider by the 2026 Scrip Awards.

MMS shortlisted for Best CRO - Specialist provider by the 2026 Scrip Awards. September 29, 2026 CANTON, Mich., and BELFAST, UK, September 29, 2026 - MMS, a leading data-focused global contract research organization (CRO), today announced it has been shortlisted in the Best Contract Research Organization (CRO) - Specialist Providers category by the 2026 Scrip Awards, recognizing the company's excellence in delivering specialized clinical development, regulatory, biometrics, and data science solutions to pharmaceutical and biotechnology sponsors worldwide. The recognition highlights MMS' continued commitment to helping sponsors navigate increasingly complex drug development challenges through scientific rigor, regulatory expertise, and technology-enabled innovation. The Scrip Awards recognize organizations that demonstrate outstanding performance, innovation, and impact across the life sciences industry. The Best CRO - Specialist Providers category honors CROs that deliver focused, high-value services, helping sponsors accelerate development timelines, enhance decision-making, and achieve successful regulatory and clinical outcomes. "For 20 years, MMS has remained focused on one goal: helping sponsors bring therapies to patients faster through innovative thinking and data-driven decision-making," said Uma Sharma, CEO of MMS. "Being shortlisted for this award reflects the dedication of our global team and the trust our clients place in us to support some of the industry's most challenging and high-priority development programs." Over the past year, MMS has continued to expand its impact across accelerated regulatory pathways, oncology, rare diseases, emerging therapeutic areas, and global submission programs. The company has supported critical regulatory milestones, while helping sponsors navigate novel regulatory considerations in rapidly evolving areas such as psychedelic-assisted therapies. MMS has supported more than 50 marketing applications over the past five years across major health authorities, including the FDA and EMA. Through its global biometrics and biostatistics expertise, MMS has also helped clients manage increasingly complex clinical data, strengthen evidence generation, and make more informed development decisions. To help sponsors manage increasingly complex clinical development programs, MMS combines specialist expertise with technology-enabled solutions. The company's proprietary platforms, Datacise(R) and KerusCloud(R), provide sponsors with advanced analytics, trial simulation, data visualization, risk monitoring, and real-time insights that improve study oversight and support more informed development decisions. Together, these technologies help sponsors generate stronger evidence, optimize trial design, and enhance submission readiness. "The industry's most complex development challenges require a partner that combines strategic thinking, scientific excellence, and innovative technology," said Ben Dudley, President and Chief Commercial Officer at MMS. "We are honored to be recognized alongside other leading organizations and remain committed to delivering the expertise, quality, and partnership our clients rely on." Winners of the 2026 Scrip Awards will be announced at an awards ceremony in London in December. About MMS. MMS is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical, biotechnology, and medical device industries with a comprehensive suite of services spanning regulatory strategy, medical writing, biometrics, data science, regulatory operations, and submissions. For 20 years, MMS has helped sponsors solve complex development challenges through scientific rigor, innovative technology, and collaborative partnerships that accelerate the delivery of therapies to patients worldwide.

MMS Holdings
Sep 22nd, 2026
MMS Holdings Recognized as one of the UK's Best Workplaces in BioPharma(TM).

MMS Holdings Recognized as one of the UK's Best Workplaces in BioPharma(TM). September 22, 2026 Belfast, Northern Ireland, and Canton, Michigan - The 2026 UK's Best Workplaces in BioPharma(TM) list was launched in September by Great Place To Work(R) UK, with MMS Holdings (MMS) recognized in the Small & Medium category. MMS prioritizes flexible working, giving employees the autonomy to manage their work while delivering exceptional results. Built on trust, accountability, and open communication, this approach helps employees feel respected, supported, and empowered to perform at their best. MMS' global reward and recognition platform helps leaders and colleagues celebrate achievements and stay connected. Quarterly SOUL (Sense of Urgency and Leadership) Awards honor employees worldwide who live the company's values and make a meaningful impact on clients, colleagues, and the business. Alongside long service and ad hoc awards, this recognition builds pride and reinforces each employee's role in MMS' shared success. As a global organization, MMS balances flexible working with opportunities for meaningful connection. Social events, client accolades, team gatherings, and personal celebrations bring colleagues together, strengthening relationships, collaboration, and MMS' strong sense of community. MMS recognizes that wellbeing needs vary across life stages. In the UK, the company has enhanced family-friendly benefits, including additional paternity leave and flexible return-to-work arrangements for new parents. MMS also provides a market-leading Employee Assistance Program and wider wellbeing support, to help employees thrive personally and professionally. Great Place To Work(R) UK determined the Best Workplaces(TM) list using its research-backed Trust Index(TM) employee survey of UK-based BioPharma employees. The survey asked employees to assess how their company supports work-life balance, fulfilment, job satisfaction, psychological safety, and financial security. Evaluations also considered how consistently organizations deliver a positive employee experience across departments and seniority levels. Andy Hunt, Associate Director of UK HR, MMS, said: "MMS is a place where people work hard, support one another, and celebrate shared success. This recognition is especially meaningful because it reflects its people's voices and the culture MMS Holdings Inc. continue to build together. Over recent years, MMS has grown significantly, including through the 2025 acquisition of Exploristics, a specialist Belfast-based biostatistics organization. Throughout this period of change, its people have shown flexibility, collaboration, and commitment to its values. This recognition helps to make MMS a great place to work." Benedict Gautrey, Managing Director of Great Place To Work(R) UK, said: "The BioPharma sector is experiencing significant change as organizations embrace digital innovation, including the growing role of AI, while navigating the impact this has on their people and ways of working. The UK's Best Workplaces in BioPharma(TM) list demonstrates that it is possible to drive transformation while maintaining a strong focus on employee experience. These organizations create cultures where people have clarity, opportunities to develop, and the flexibility to do their best work. Through trusted leadership, open communication, and inclusive approaches to decision-making, they help employees feel supported, confident, and ready to embrace the future. Congratulations to MMS on being recognized as a UK's Best Workplace in BioPharma(TM) and for creating a workplace where people can thrive through change." About MMS Holdings. MMS Holdings (MMS) is an award-winning, data-focused clinical research organization (CRO) supporting pharmaceutical and biotechnology companies with a proven scientific approach to complex clinical trial data and regulatory submission challenges. MMS delivers measurable value through deep regulatory expertise, advanced analytics, and a commitment to quality across the development lifecycle. About Great Place To Work(R). Great Place To Work(R) is the global authority on workplace culture, on a mission to make every company a great workplace for all. Every year, they receive direct feedback from over 10 million workers around the world telling them how they really feel about their employer. Their survey is completely confidential and anonymous, so people can feel comfortable to be honest about their workplace, and companies can gain detailed insights into how they can better serve their people. Only those employers who have the highest levels of trust, job satisfaction, and who empower ALL their employees to thrive both in and outside of work are awarded official Best Workplaces(TM) recognition. Media contact. Caitlin Magee [email protected]

MMS Holdings
Feb 12th, 2025
MMS Acquires Exploristics for Data Science Expansion

MMS, a clinical research organization, has acquired Exploristics, a biostatistics and data science company. This acquisition enhances MMS' capabilities in advanced clinical trial design and data science, integrating Exploristics' KerusCloud® platform. The move expands MMS' global presence, particularly in Europe, and aims to optimize drug development strategies, reducing time and costs. Exploristics' CEO, Aiden Flynn, joins MMS as Senior VP, Head of Strategic Statistical Consulting.

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MMS Holdings
Apr 18th, 2023
MMS Named Great Place To Work In The UK

MMS Holdings Inc. plan to expand and grow in the UK and Europe to build on its teams and deliver value to its clients”