Medical Writer

SUMMARY

Our client is hiring a Medical Writer to join the team.

A suitable candidate should be a motivated and multi-skilled individual that meets the requirements of the role.

DUTIES TO INCLUDE

• Drafts and edits documents used for submissions including CTDs and RtQs.
• Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms.
• Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PSURs, DSLRs, etc.).
• Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes.
• Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
• Works effectively with cross-functional groups.
• Other tasks as assigned.

KEY REQUIREMENTS

ESSENTIAL

• Professional medical writing experience for a medical communications company.
• Experience in digital writing and quality checking site builds.
• Experience in writing for pharma and applying the digital ABPI Code of Practice.
• Ability to translate complex topics into highly simplified, layman terms.
• High attention to detail and accuracy; strong written and verbal skills.
• Adaptable and flexible writer, able to write empathetically according to the audience.
• Ability to process and meet client objectives.
• Excellent organizational skills, initiative, and ability to meet deadlines on time.
• A visual thinker with an interest in working in a creative health-tech environment.

DESIRABLE

• Writing for patients/lay audiences.
• Writing across therapy areas.
• Scriptwriting and/or media experience (such as filming, 2D/3D animation, etc) or an interest in the media and gaming industry.
• Interpreting qualitative data or patient-reported outcomes.
• Conducting focus groups.
• Experience in education.
• Confidence in using referencing and approval systems.