Scientific Medical Writer
SCIENTIFIC MEDICAL WRITER
In this exciting and challenging role the Scientific Medical Writer acts as the medical writing expert responsible for managing, writing and editing of study level documents. The Scientific Medical Writer acts as the medical writing expert responsible for managing, writing and editing of study level documents. He/She provides lifecycle support from clinical study protocol through clinical study report preparation. Responsibilities will include assuring quality and timely preparation of clinical documents as assigned. This is a global role based in Espoo, Finland.
YOUR TASKS AND RESPONSIBILITIES
• Implement the content strategy for all study level clinical documents as assigned.
• Drive the design of all assigned study level documents in support of the Clinical Development Plan under the leadership of Medical Writer Strategist or Submission Medical Writer.
• Independently author study level documents (collaborating with the team for content input), implement project level data presentation and message standards for the assigned documents, validate individual study protocol design and clinical study report key messages based on the strategy provided.
• Be accountable for the format, content and adherence to global regulatory guidance and electronic publishing standards of the individual clinical documents that he/she is the author of.
WHO YOU ARE
• A Bachelor’s degree and a minimum of 4 years' experience in the pharmaceutical industry, or a Master degree and a minimum of 2 years' experience in the pharmaceutical industry, or a PhD in natural sciences or equivalent degrees are highly preferred.
• The incumbent must have a thorough understanding of the overall drug development process. Specific knowledge of the clinical study report development process, regulatory and drug safety requirements, and clinical data management and statistical processes/functions is required.
• Working knowledge of current electronic authoring, document management and electronic regulatory submissions is highly preferred.
• The incumbent must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas. The incumbent must be diplomatic, persuasive and be able to establish rapport with all key functional leaders and experts in the SBU Oncology Development organization.
• Excellent written and oral English.
• Flexibility and good interpersonal skills, ability to meet or exceed customer expectations and work efficiently, precisely and independently under tight time-lines in a global work environment
We offer an independent role in a global life science company with a chance to develop your skills and experience further. To be considered for this exciting opportunity, please submit your application at your earliest convenience and no later than Sunday April 19, 2020. Candidates will be reviewed on a continuous basis.
If you are passionate about scientific medical writing, we are keen to hear from you!
For further information, please contact Tarja Jalava (Head, Clinical Project Management II, Oncology Strategic Business Unit) on Wednesday April 15 at 10-11 orThursday April 16 at 11-12 by phone +358 40 523 0834
Functional area: Clinical Development & Operations
Seniority level: Professional