Experienced Medical Writers (Regulatory Documentation Scientist)

Job description

  Job facts

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 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.

Desired profile

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


If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you. In return we offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation, including a genuine interest in your development and progression.

To be considered for this position, please apply using the link below.

When completing your application, please ensure you attach an up to date CV and details of your current remuneration package.

·