Medical Writing Manager

Hobson Prior are currently looking for a Medical Writing Manager to join a fantastic international establishment on a permanent basis with the ability to work remotely from anywhere within France. Our client is focused on developing solution for the transport needs, logistics and distribution requirements of their clients.

Please note that to be considered for this role you must have the right to work in this location.
- **Key Responsibilities**:

- Conduct key content evaluations, correctly comprehend outcomes, recognise possible limitations and discuss unexpected discoveries.
- You will respect and implement suitable EHS guidelines and processes.
- Partake in forming skills and technical skills across the medical writing division.
- Guarantee clear, factual, efficient and suitably concise presentation of analysis and affiliated conversations in allocated reports.
- Any other assigned duties.

**Key Skills**:

- Solid diagnostic, analytical and process improvement skills.
- Cross-cultural awareness and sensitivity.
- Managerial capability with proven leadership profile.
- Capable of seeing the bigger picture with a high attention to detail, as well as to represent the organisation in a professional manner.
- Able to assume the initiative with a positive outlook in all situations.
- A patient individual who is open to tough critiques.
- Capable of presenting information in a clear, precise, logical, and non-technical fashion.
- Comprehension of the target audience requirements.
- Assumes responsibilities, delegates effectively, retains responsibility.
- An organised individual who is proactive, respects metrics, driven to meet deadlines and assumes responsibility for quality of work.

**Requirements**:

- Educated to an advanced degree level in a pertinent scientific field, or at least 7+ years of experience in a pharmaceutical, biotech, academic or CRO establishment with an advanced degree, or at least 10+ years of experience in those establishments with a Bachelor's degree.
- Familiarity with guiding, preparing, writing, organising and supervising the clinical reports for international regulatory archiving.
- Experience with regulatory medical writing and CTD submission writing.
- Know-how of various therapeutic areas, regulatory/scientific regulations, and crucial statistical notions.
- Acquainted with writing various documents/reports within a pertinent therapeutic field.
- Dedicated to data integrity and reporting standards.
- Listening abilities to resolve issues, deliberate, and make decisions.
- Consciousness and comprehension of clinical / pre-clinical pharmaceutical research and development arena.
- Able to assimilate knowledge and comprehension of a new therapeutic field.
- Prior involvement handling medical writing projects within a predominately outsourced model or guiding medical writing teams both internally and externally on a remote basis.
- Experience with operational project management which involves planning and handling various priorities simultaneously.
- Fluency in the English language.
- Know-how of international regulatory proposal needs, document management systems, pertinent therapeutic areas and any other aspects of drug development such as nonclinical, pharmacokinetics, biostatistics, etc.
- Know-how of Good Clinical Practices, FDA guidelines, ICH regulations, and the drug development process.
- Computer literacy in MS Office Suits such as Excel, Word and PowerPoint, as well as MS Project.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.