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Job Details

Senior / Principal Medical Writer

Company: PAREXEL
Location: UK or Spain, office or home based
Reference: 16034
Closing Date: 13 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits: Benefits: Competetive salaries, Medical Insurance, Pension scheme, generous holiday entitlement, flexibe hours, on-site parking, Employee Stock Purcha

Job Summary:

Leading CRO PAREXEL is looking for experienced Senior / Principal Medical Writer. Excellent opportunities and competetive benefits available.

Requirements:

Essential Function of the Senior / Principal Medical Writer:

The Principal Medical Writer will research, create, and edit documents associated with the clinical sections of regulatory submissions and clinical documents that may or may not be associated with submission to a regulatory agency. This is a billable position. The Principal Medical Writer facilitates process improvement and technical mentoring/training. The Principal Medical Writer also supports Medical Writing Services management during the sales process by providing client liaison and proposals input.

Key Accountabilities of the Senior / Principal Medical Writer:

Writing and consultancy for assigned projects

- Prepare, review, and edit key documents for regulatory submissions without the need for any supervision or formal training. Train self to prepare any type of medical writing deliverable.
- Provide technical leadership to ensure that clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission.
- Review of ongoing and/or revised project documentation and correspondence.
- Coordinate production and distribution of draft and final documents to project team and client. Ensure that all work is complete and of high quality prior to team distribution or shipment to client.

Project management

- Serve as primary contact for client's technical liaison. Establish working relationship with client's technical group to promote client satisfaction and confidence.
- Provide leadership and strategic re-planning, delegation of responsibilities and tasks to team members. Monitor the progress of each individual project task and assess the overall program. Monitor overall project performance in an ongoing way and if necessary identify ways to ensure that the project is completed on-time and within budget. Keep client and project team informed of study status.

Process improvement:


- Be familiar with all Medical Writing Services Department SOPs and guidelines. Analyze efficiency of work and discuss improvement ideas with Medical Writing Services management and colleagues. Provide guidance to other members of the department on acceptable and current medical writing issues/procedures.
- Implementation and monitoring of departmental compliance to SOPs. Input to development or revision, as appropriate, of departmental Standard Operating Procedures (SOPs).

Training/mentoring

- Present details of technical courses attended or new knowledge acquired. Provide in-house training courses as required.
- Produce training material for and present external training courses.
- Provide training and act as a mentor for less experienced MWS members.


Client liaison/service

- Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management.
- Provide strategic and project planning intelligence to Medical Writing Services management for medical writing activities in proposal generation process, including assessment of scope of services to be provided to a client with respect to medical writing tasks. May attend proposal development meetings if requested by Medical Writing Services management.

The ideal candidate for the role of the Senior / Principal Medical Writer will have:

Skills

- Excellent interpersonal, negotiation, verbal and written communication skills.
- Client focused approach to work.
- A flexible attitude with respect to work assignments and new learning.
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
- Motivation to work consistently in a fast-paced, rapidly changing environment.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Team orientated.
- Leadership skills that include the ability to gain trust and confidence with a variety of clients as well as within the company.
- Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines.
- Knowledge of resource management and productivity metric management.
- Strong word processing skills, including familiarity with MS Word for Windows.

Education

- Bachelor's degree in Life Sciences/Health-Related Sciences or equivalent.

Language Skills

- Fluent in written and spoken English.

Minimum Work Experience

- Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects.

Physical Requirements

- Ability to travel. (15%)

Apply for this job: Senior / Principal Medical Writer

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
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