Submission Medical Writer – Bayer4.12.2021
About the job
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 Clinical Development & Operations team in Finland in Espoo as
SUBMISSION MEDICAL WRITER
Your Tasks And Responsibilities
- Independently author study level clinical documents and clinical submission documents, reviews and is responsible for their consistency.
- Implement the submission authoring strategy under the leadership of the MW Strategist.
- Supports the MW Strategist to manage the activity, resource and time planning for the clinical part of submissions.
- Drives the design of clinical submission documents in support of the Clinical Development Plan, validates individual study protocol design, key messages of the clinical study report and other clinical submission documents, for assigned projects.
- Maintains current knowledge on all regulatory agency medical review guidelines and drug approval requirements for assigned projects.
- Implement the content strategy for all clinical documents as assigned.
- 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.
- Mentors Associate Submission Medical Writers and Senior Scientific Medical Writers (internal and insourced) in developing expertise.
- Active communication and collaboration with study teams.
- Support other medical writing processes as applicable.
Who You Are
- This position requires a Bachelor’s degree and a minimum of 10 years experience in the pharmaceutical industry or a Master degree and a minimum of 8 years experience in the pharmaceutical industry or a PhD and a minimum of 6 years experience in the pharmaceutical industry. In all cases, the candidate should have at least 6 years experience in regulatory medical writing, 4 of which should be in writing the submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews, etc.).
- PhD in natural sciences or equivalent degree is highly preferred.
- The incumbent must possess strong planning and project management skills and experiences. Project management certification is highly preferred.
- The incumbent must have experience in developing clinical documents in support of regulatory submissions globally (i.e., multiple regions).
- The incumbent must have an in depth understanding of all regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (eg ICH, FDA, EMEA).
- 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.
- Experience in supporting diverse indications is preferred.
- The incumbent must have experience in leading teams and mentoring medical writers for at least 2 years.
- The incumbent must also have an excellent working knowledge of current electronic authoring, document management and electronic regulatory submissions.
- 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 Pharma Research & Development organization.
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 15 Dec, 2021. Candidates will be reviewed on continuous basis and the position will be filled after the suitable candidate has been found.
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, 8 Dec 2021 at 13.00-14.00 (EET) and 9 Dec 2021 at 15.00-15.30 phone +358 40 0423633.
Functional area: Clinical Development & Operations
Seniority level: Professional
Location: Espoo, Finland