Principal Medical Writer

Proclinical is working with a world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. This Medical Writer role will be based in London on a permanent basis. The Principal Medical Writer applies intermediate to advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.

Job Responsibilties:

• 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 (eg. PSURs, DSURs).
• 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 within the company.
• Other tasks as assigned.

Skills and Requirements:

• Bachelor's or higher degree preferred; scientific focus desirable.
• Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing.
• Evidence of medical writing career development desirable, eg, European Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
• Good experience in medical writing in the pharmaceutical industry.
• Good understanding of the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.
• Good understanding of clinical study data collection and results reporting.
• Previous protocol development experience required.
• Experience writing, reviewing, or editing protocols and clinical study reports.
• Experience writing, reviewing, or editing INDs and BLA/NDAs.
• Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.
• Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.
• Ability to interpret tabular and graphical clinical data presentations.
• Ability to create tables using AMA style (eg, Schedule of Events).
• Intermediate applied knowledge of clinical laboratory tests.
• Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
• Understanding of biostatistical and clinical research concepts.
• Proficient in Microsoft Word (including the use of templates), MS Project, Excel, and PowerPoint.
• Experienced with scanners, printers, and copiers.
• Knowledge of regulatory requirements and guidances associated with 'standalone' regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
• Ability to develop Module 2s of INDs/NDAs in the eCTD format, EU Risk Management Plans, aggregate safety updates (e.g. PSURs, DSURs) and responses to EMA queries.
• Capable of working on multiple tasks and shifting priorities.
• Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation.
• Good conflict management skills.
• Motivated and shows initiative.
• Detail oriented.
• Capable of well organized, concise and clear written and verbal communication.
• Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
• Effective at explaining writing principles to a varied audience both in individual and group settings.
• Good presentation skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Tom Russell on +44 203 8246 104 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.