Senior Medical Writer (Home Based - South Africa)

MMS Holdings Inc.; Bloemfontein; Remote; ZAR 400,000 - 600,000; Full time

Job summary

MMS Holdings Inc., une organisation de recherche clinique, recrute un Senior Medical Writer pour rejoindre son équipe en Afrique du Sud. Le candidat idéal doit avoir une expertise en rédaction médicale, une expérience significative en oncologie et la capacité à gérer des délais serrés tout en interagissant directement avec les clients. Ce poste, basé à domicile, offre une occasion unique de contribuer à des projets de recherche significatifs dans un environnement collaboratif.

Qualifications

• Expérience de 3-5 ans en rédaction médicale et réglementaire.
• Expérience substantielle en oncologie.
• Compétences exceptionnelles en rédaction et en gestion de délais.

Responsibilities

• Écrire et éditer des documents de développement clinique.
• Évaluer et sélectionner la littérature médicale pour la conception d'études.
• Maintenir l'organisation et respecter les délais de livraison.

Skills

Rédaction médicale

Gestion de projet

Analyse critique

Compétences en communication

Compétences organisationnelles

Education

Diplôme en sciences, médecine ou discipline clinique

Tools

MS Word

Excel

PowerPoint

Job description

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 an award-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-leading 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 or follow MMS on [insert platform].

Senior Medical Writer

We are recruiting for a Medical Writer to take on a vacant position in our South Africa team. We are looking for a motivated self-starter, preferably with medical writing experience who is looking for a new challenge. This position is a home-based role out of any location in South Africa.

Roles & Responsibilities

• Under minimal supervision, critically evaluate, analyze, and interpret the medical literature to select primary resource materials for 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, safety and efficacy summaries, and publications for medical journals.
• Complete writing assignments in a timely manner and maintain workflow and timelines.
• Practice good internal and external customer service.
• Highly proficient with styles of writing for regulatory documents and familiar with client templates and style guides.
• Interact directly and independently with clients to coordinate project aspects; demonstrate competent communication skills.
• Contribute to or manage the production of interpretive guides.
• Take ownership of assignments, proactively consulting team members and departments as needed.
• Mentor medical writers and project team members involved in writing processes.

Requirements

• At least 3 years of experience in the pharmaceutical industry.
• 3-5 years of industry regulatory and clinical medical writing experience.
• Degree in scientific, medical, or clinical discipline (Bachelor’s, Master’s, or Ph.D.).
• Substantial Oncology experience.
• Experience leading clinical study protocols as lead author.
• Experience managing teams and authoring regulatory documents under tight deadlines.
• Experience with regulatory submissions (clinical study reports) is a plus.
• Understanding of clinical data and exceptional writing skills.
• Excellent organizational skills and ability to multitask.
• Expertise in MS Word, Excel, PowerPoint, and related tools.
• Experience as a project lead or managing project teams.
• Knowledge of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.
• Experience with orphan drug designations and PSP/PIPs is a plus.

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