Director - Medical Writer

ClinChoice

Multiple Locations, Europe

Main Job Tasks and Responsibilities:

The Director of Medical Writing will lead the medical writing function and will coach and grow the team. The Director may function as a Lead Medical Writer on a variety of regulatory writing deliverables; will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. The Director will conduct senior review of medical writing deliverables (CSR, IBs, Protocols, etc.) and negotiate timelines and discuss/resolve clients’ comments. This role will provide written and verbal feedback to the internal team, and to 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.

Lead the medical writing team – mentor the team and oversee all the aspects of project delivery for global clients;
Take 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, communicating directly with the clients;
Plan and organize workload for assigned projects and tasks: identify project needs, track timelines, and implement clients’ requests;
Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed;
Present on Medical Writing processes at full-service bid defense meetings;
Develop and deliver training to the global team in various aspects of medical writing;
Facilitate project budgeting activities for the medical writing scope by collaborating with the BD team;
Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables;
Oversight of a portfolio of clients. This includes, but not limited to:
- 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;
- Provide scientific and technical guidance to the client and Medical Writers.
Provide 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;
Keep Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations;
Serve as the primary client contact and Medical Writing representative on assigned project teams, providing support to 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 to 15 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills;
Experience working on end-to-end CSR, IBs, Protocols across different TAs is mandatory for pharmaceutical and medical device products. Experience in DSUR will be considered as 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; attentive to details;
Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed client and regulatory timelines; monitor and communicate 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.

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