JOB TITLE: MEDICAL WRITING DIRECTOR, ITALY - P

Description.
Location.
Italy - Hybrid (2 days in office)  Schedule.
Full-time, Permanent       CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Medical Writing Director.
The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines.
This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments.
This role will provide written and verbal feedback to the internal team and clients when appropriate.
She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development.
Join our team and help us deliver clinical trials that will improve patients' lives.
Main Job Tasks and Responsibilities.
Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.
Plans and organizes workload for assigned projects and tasks identifies project needs, tracks timelines, and implements clients' requests.
Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.
Presents on Medical Writing processes at full-service bid defense meetings.
Develops and delivers training to the global team in various aspects of medical writing.
Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.
Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.
Oversight of a portfolio of clients.
Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.
Provides scientific and technical guidance to the client and Medical Writers.
Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution.
This includes both copy editing and content review.
Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.
Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables.
Education and Experience.
At minimum a Bachelor's degree or equivalent in medical-related field or life science.
Post-graduate degree preferred.
At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.
Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory.
Experience in DSUR will be considered an added advantage.
An understanding of the drug development process.
Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.
Experience in interacting with cross-functional study team members.
Specific Role Requirements and Skills.
Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.
Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.
Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.
Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
Read, write, and speak fluent English, excellent verbal, and written communication skills.
Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.
Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.
Culturally aware and able to work comfortably within a global team.
The Application Process   Once you have submitted your CV, you will receive an acknowledgment that we received it.
If you have the requirements, you will be invited for a phone interview as the first step.
Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
If you would like to discuss the role before applying through the website @ https://www.
alentsourcelifesciences.
om/jobs    please contact mailto.
[email protected] @cromsource.
om for more information.
Who will you be working for?       About CROMSOURCE       CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since , has been supporting our clients with outstanding clinical research and staffing solutions services.
The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos   Our employees are the most valuable company asset.
We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents.
Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel.
The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.
The success of these core values is evidenced by our below-industry average turnover rates.
About TalentSource Life Sciences   TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions.
Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth.
For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.
CROMSOURCE is an equal opportunity employer.
All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status.
CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Keywords.
Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writing.
Skills.
Medical Writer, CER, clinical trials, Medical Writing, Outsourcing, Pharmacology Location.
Italy