Medical Writer (South Africa) at MMS

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 fresh challenge. This position is a home-based role out of any location in South Africa, however suitable Bloemfontein-based candidates will receive preference.

Roles And Responsibilities

Medical Writing

• Responsible for scientific medical writing and producing high quality documents in an efficient manner.
• Maintain a strong understanding of regulations and guidance as they pertain to medical writing.
• Understand MS Word for advanced writing techniques.
• Understand styles of writing for various document types.
• Proficient with client templates & style guides.
• Address client comments during document lifecycle and provide value added suggestions; develop comment resolution logs as needed; communicate important decisions to team; manage revisions.
• Implement and validate QC findings.
• Assume responsibility for quality and integrity of documents.
• Conduct thorough self-review of deliverables prior to release to client.
• Demonstrates extensive knowledge of departmental processes.

Project Management

• Follow processes related to project management as appropriate for medical writing projects (e.g. close-out procedures etc).
• Manage project risk and timeline.
• Effectively manage multiple projects and delegate as needed to complete projects on time.
• Notify project manager and line manager of changes to scope and timeline.

Client Management

• Manage day-to-day client interaction.
• Develop lasting relationships with client personnel that foster client ties.
• Set and manage client expectations.
• Understands client needs and preferences and develops documents according to client specifications.

Communication

• Facilitate team and client meetings effectively;
• Effectively communicate relevant project information to applicable colleagues
• Resolve and/ or escalate issues in a timely fashion
• Keep project team well informed of changes within the project

MMS Core Values

• Display internal and external leadership skills
• Represent self and company in a professional manner and in line with core company values.
• Practice excellent internal and external customer service, communication, and team work.
• Support objectives and improvement efforts within department and organizationally.
• Comply with all applicable policies, procedures, and training requirements.
• Additional tasks as assigned by manager.

Job Requirements (Minimum Education / Experience / Training / Skills)

• Bachelor’s Degree in scientific, medical, clinical discipline or related field is required; Masters or Phd with 1 to 3 years of previous medical writing experience or post-graduate work preferred.
• Hands-on experience with clinical trial and pharmaceutical development preferred
• MW I and II distinction is based upon education, previous experience, years of service at MMS and level of independence and expertise.
• Familiarity with current ISO Standards
• Excellent scientific writing skills required
• Understanding of scientific, medical, and/or clinical data required
• Experience in the pharmaceutical or CRO industry preferred
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.