Technical Writer, Oncology

Job description

  Job facts

The Documentation Specialist will assist with clinical document -related editing and proof reading activities supporting Clinical Expert Teams/Study Management teams:

·  Supports the development of high-quality clinical documents e.g. study protocols, amendment documents, informed consent forms, subject information leaflets etc.
·  Is accountable for Planning, creation and co-ordination of timelines for the production and review of clinical protocol-related documents ensuring alignment with overall project timelines.
·  Co-ordinates the clinical protocol-related documents draft and review process including generation of draft document from content provided by contributing authors; collection, adjudication, and incorporation of comments from team, cross-functional and functional reviewers; and resolution of issues/errors/inconsistencies with team members.
·  Edits and/or proof-reads pRED clinical protocols and related documents. Is accountable to ensure consistency, accuracy and compliance with local and global guidelines.
·  Supports selection and management of appropriate templates within documentation system.
·  Is accountable to ensure documents are published and approved by the accountable signatory.
·  Provides support to technical review meetings such as DRC (minutes, etc)
·  Participates as needed as a member or ad-hoc participant of key functional/cross-functional teams (i.e., project team, clinical team, study management team) to ensure appropriate documentation guidance and support.
·  Collaborates with Regulatory Clinical Documentation Group to ensure consistency of submission documentation.

·  Who we are

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more .

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.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at .
EEO is the Law

PAY TRANSPARENCY NONDISCRIMINATION PROVISION
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

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.

You own a Bachelors degree or equivalent. An advanced degree in life sciences (i.e., MS, PhD) or other relevant field is preferred.

·  Demonstrated clear, high-quality scientific writing style in the English language.
·  Experience in early stage drug development is preferred.
·  Thorough understanding of multidisciplinary functions involved in early stage Drug Development Process is essential (e.g., Clinical Operations, Biostatistics, Regulatory, etc.).
·  Experience as a coordinating author and with providing editing and prof-reading support for clinical documents for various therapeutic areas and global programs is desirable. Experience with working on clinical documents in the field of Oncology
·  Understanding of Federal Regulations and International standards as they pertain to reporting of clinical trials.
·