Location: Welwyn Garden City, Hertfordshire, UK
Closing Date: 28 Dec 16
Type: Full Time
Salary (£): Negotiable
• Medical Writer/Regulatory Documentation Scientist • Leading Pharmaceutical company • 6 month contract • Freelance opportunity • Welwyn Garden City
The source department of Chiltern acts in a similar way to that of a staffing solutions provider. My client is a leading Pharmaceutical company they are looking for a Regulatory Documentation Scientist to join their team, office based in Hertfordshire. Candidates will work on a freelance basis, full time office based in Welwyn Garden City. Home working maybe considered upto 3 days a week at the managers discretion after working 2 months.
The department prepares documents to meet the evolving needs of Health Authorities using expertise in writing, science and regulatory requirements. As a valued member of the department, you will be working with global drug development teams to bring novel pharmaceutical products to patients worldwide through planning and preparing a broad range of regulatory documents. The scope encompasses periodic safety reports, risk management plans, clinical study reports, and summaries of clinical data across studies, among many other document types. In addition to authoring individual documents, you may also be responsible for broader oversight and management of the regulatory documents for a molecule or project within the portfolio.
In this role, you will work closely with colleagues in safety science, biostatistics, clinical science, and regulatory affairs, among other functions, on projects across the drug development lifecycle and a range of therapeutic areas.
A full job description is available.
• Ph.D., MS, or equivalent in a biomedical discipline or a qualification in pharmacy, nursing, or another healthcare discipline.
• Previous medical writing experience, and experience writing regulatory documents in the pharmaceutical/biotech industry.
• Knowledge of Good Clinical Practice and/or Pharmacovigilance guidelines.
Experience, Knowledge, Skills
• Demonstrate clear, high-quality scientific writing in the English language
• Ability to independently analyze and synthesize data from a broad range of disciplines
• Project management skills: consistently achieve multiple tasks and goals on-time
• Good interpersonal and verbal communication skills
• Ability to work effectively in a team environment, establish strong collaborative relationships
• Experience in regulatory affairs or related functions in drug development is an advantage
To apply for this position please email your CV to firstname.lastname@example.org
Please note that if your experience does not mirror that of the requirements for this role you may not receive a response.
Candidates must be eligible to work in the UK.
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