Senior Medical Writer (Remote)

MMS; Atlanta (GA); Sur place; USD 110 000 - 140 000; Plein temps

Résumé du poste

MMS is a data-focused CRO seeking an experienced Medical Writer to craft regulatory and clinical development documents. The role involves leading writing projects, mentoring junior writers, and coordinating directly with clients on study designs and submissions.

The candidate should have 3–5 years in regulatory/clinical writing, strong MS Office skills, and a solid understanding of GCP/ICH guidelines. This is an on-site position in Atlanta, with opportunities to contribute to multi-asset therapy

Qualifications

• 3+ years in the pharmaceutical industry.
• 3-5 years regulatory writing and clinical medical writing.
• Bachelor's, Master's, or PhD in scientific/medical field.
• Lead author for clinical study protocols required.
• Experience with regulatory submissions and clinical study reports is a plus.
• Strong understanding of clinical data and regulatory requirements.
• Exceptional writing and communication skills.
• Excellent organizational and multitasking abilities.
• Expert in MS Word, Excel, PowerPoint and related tools.
• Experience as project lead or managing a project team.
• Knowledge of GCP/ICH guidelines is advantageous.

Responsabilités

• Critically evaluate, analyze, and interpret medical literature for study design and bias.
• Write and edit clinical development documents including protocols and study reports.
• Complete writing tasks in a timely manner and maintain timelines.
• Interact with clients and coordinate project facets with teams.
• Mentor medical writers and project team members.
• Produce interpretive guides and client deliverables.
• Ensure compliance with regulatory templates and style guides.
• Lead and manage document production under tight timelines.
• Communicate effectively with stakeholders to resolve questions.
• Support regulatory submissions and publications to medical journals.

Connaissances

Regulatory writing

Clinical writing

Project leadership

MS Word

MS Excel

MS PowerPoint

Formation

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

Outils

MS Word

MS Excel

PowerPoint

Description du poste

About MMS

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

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
• Not required, but experience with orphan drug designations and PSP/PIPs a plus