We are now looking for a professional with thorough understanding of the overall drug development process and with excellent working knowledge of document authoring to work in an exciting and challenging global role based in a growing Clinical Development Operations team in Finland in Espoo as
SENIOR SCIENTIFIC MEDICAL WRITER
YOUR TASKS AND RESPONSIBILITIES
- Implement the content strategy for all clinical documents as assigned
- Drive the design of all assigned study level documents in support of the Global Clinical Development Plan (CDP) under the leadership of MW Strategist or Submission Medical Writer.
- Act as the medical writing expert responsible for managing, writing, and editing of study level documents, amendments, reports and supporting submission level documents.
- Provide full lifecycle support from clinical study protocol through regulatory dossier preparation and submission.
- Independently author study level documents (collaborating with the team), support project level submission documents under the leadership of the Associate Submission Medical Writer or Submission Medical Writer, implement project level data presentation and messaging standards for the assigned documents, validate individual study protocol design and clinical study report (CSR) key messages based on the strategy provided.
- Accountable for the format, content and adherence to global and electronic publishing standards of the individual clinical documents that he/she is the author of.
- Active communication and collaboration with study teams.
- Support other medical writing processes as applicable.
- Mentor and coach Associate Scientific Medical Writers.
WHO YOU ARE
- Bachelor’s degree in natural sciences and a minimum of 6 years experiences or an advanced degree in natural sciences and a minimum of 3-4 years experiences in the pharmaceutical industry. In all cases, the candidate should have at least 3-4 years experiences in medical writing.
- PhD or Master’s degree are highly preferred.
- Experience in developing clinical documents in support of regulatory submissions globally in multiple regions are highly preferred.
- Have an in depth understanding of all regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (e.g. ICH, FDA, EMEA).
- 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.
- Have an excellent working knowledge of current electronic authoring, document management and electronic regulatory submissions.
- 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 Global Development organization.
- Excellent collaboration, networking, and presentation skills.
- Strong analytical skills.
- Excellent organization and prioritizing skills.
- Profound IT-skills (Word, Adobe).
- 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 a competitive compensation, independent and challenging role in an international environment with a chance to develop your skills and experience further. To be considered for this exciting opportunity, please submit your application by Thursday March 18, 2021. Candidates will be reviewed on continuous basis.
If you feel this unique role is just what you are looking for, we are keen to hear from you! For further information, please contact Päivi Norja, Head of Authoring II, Monday March 8, 2021 at 14.00–15.00 (EET) and Thursday March 11 at 13.00-14.00 (EET), phone+358040423633.
Functional area: Clinical Development Operations
Seniority level: Professional
Location: Espoo, Finland,