Senior Medical Writer (Remote - Mexico)

mmsholdingsinc; Ciudad de México; A distancia; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

MMS Holdings Inc. is seeking an experienced Medical Writer to join our remote team in Mexico. The role focuses on critical literature evaluation and the creation of comprehensive regulatory writing documents for clinical development.

Ideal candidates will have 3+ years in pharma, strong writing skills, and experience leading project teams under tight timelines. Remote-based work within Mexico is offered with opportunities to collaborate globally.

Formación

• 3+ years of pharmaceutical industry experience.
• Expertise in regulatory writing and clinical medical writing.
• Experience leading and managing teams with tight timelines.
• Strong scientific writing and communication skills.

Responsabilidades

• Critically evaluate literature to select primary resources for study design and regulatory reporting.
• Write/edit clinical development documents (protocols, investigator brochures, study reports, consent forms).
• Prepare safety/efficacy summaries and regulatory modules.
• Meet timelines and manage writing workflows.
• Mentor writers and project team members.
• Coordinate with clients to manage projects and deliverables.

Conocimientos

Regulatory writing

Team leadership

Clinical writing

Medical writing

Educación

Bachelor's/Master's/PhD in scientific/medical/clinical discipline

Herramientas

MS Word

MS Excel

PowerPoint

Descripción del empleo

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is aaward-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate.We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

We are looking for a full-time employee, remotelybased within any location in Mexico.

Responsibilities

• Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the 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 but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 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.
• Maintain timelines and workflow of writing assignments.
• Practice good internal and external customer service.
• Highly proficient with styles of writing for various regulatory documents.
• Expert proficiency with client templates & style guides.
• Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects.
• Contribute substantially to, or manages, production of interpretive guides.
• Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary.
• Mentor medical writers and other members of the project team who are involved in the writing process.

Requirements

• At least 3 years of previous experience in the pharmaceutical industry.
• Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience.
• The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline.
• Substantial clinical study protocol experience, as lead author, required.
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus.
• Understanding of clinical data.
• Exceptional writing skills are a must.
• Excellent organizational skills and the ability to multi-task are essential prerequisites.
• Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools.
• Experience being a project lead, or managing a project team.
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus.
• Substantial clinical study protocol experience, as lead author, required.
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
• Not required, but experience with orphan drug designations and PSP/PIPs a plus.

Please consider your application unsuccessful if we do not reach out to you within 14days of your submission.