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Job Details

Experienced Medical Writers (Regulatory Documentation Scientist) - 12 month fixed term contract and ongoing permanent opportunities

Company: Roche
Location:
Reference: 3405113354
Closing Date: 26 Aug 17
Type: Full Time
Salary (£): On Application
Benefits:

Top Job

Job Summary:

Here is a great opportunity to combine your scientific knowledge and writing skills in an important role with one of the world's leading healthcare companies. Roche’s Global Regulatory Documentation department prepares documents to meet the evolving needs of Health Authorities using our expertise in writing, science and regulatory requirements. ...

Requirements:

Here is a great opportunity to combine your scientific knowledge and writing skills in an important role with one of the world's leading healthcare companies.

Roche’s Global Regulatory Documentation department prepares documents to meet the evolving needs of Health Authorities using our 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. Our 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. You will also have the opportunity to contribute to best practices and continuous improvement activities and to take part in mentoring programs within Regulatory Documentation. 

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Qualifications

You will have a Ph.D., MSc, or equivalent in a biomedical discipline or a qualification in pharmacy. Postdoctoral work would be an advantage. You will have previous medical writing experience, or a background in pharmacovigilance and a strong will to develop medical writing skills. Experience writing regulatory documents in the pharmaceutical/biotech industry will be especially valuable.  You have knowledge of Good Clinical Practice and/or Pharmacovigilance guidelines.  In addition, you are a skilled communicator, comfortable working as part of cross-functional teams, and have the strong organizational skills necessary to deliver multiple documents on schedule. 

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

 

Please be advised that you require approval from your Line Manager before making a formal application. Good luck with your application.

 

We have an immediate requirement for a 12-month Fixed Term Contract. 

In addition, please be aware that this in an ongoing posting for positions that may become available in the short to medium term.  Please do include a cover letter with your application and detail whether you are interested in a Fixed Term Contract, permanent opportunity or both.

 

The next step is yours. To apply today, click on the "Apply online" button below.

 

We operate a strict Preferred Supplier List (PSL) and will not accept or respond to contacts from agencies outside of our PSL.  Direct contact with hiring managers may jeapardise future PSL considerations.

 

Who we are

Our UK Pharmaceutical head office is situated in Welwyn garden City, Hertfordshire, with beautiful country side surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. With over 1400 people occupying our site in Welwyn, you can expect opportunities in Early Development (pRED), Product Development (PD), Commercial (Rx) and of course our corporate function.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Apply for this job: Experienced Medical Writers (Regulatory Documentation Scientist) - 12 month fixed term contract and ongoing permanent opportunities

Contact Information:

Address:  UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
AL7 3AY
England
Tel:  +44 1707 36 6000
Fax:  +44 1707 33 8297
Website:  Visit Our Web Site

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