Your tasks and responsibilities
Advancing Life - That’s what we at Bayer are all about.
We put ourselves to the test day in day out. All together. All over the world. With enthusiasm for new ideas.
Bayer has traded in the UK and Ireland since Friedrich Bayer first sold his dyestuffs here in 1871
Today our UK and Ireland region is headquartered in Green Park, Reading. The office serves as home to Pharmaceuticals, Consumer Health and Animal Health, as well as our pivotal business and administrative service function. Our Crop Science business is based in Cambridge and our Ireland businesses are based in Dublin.
Bayer is now recruiting for a Submission Medical Writer. This is an exciting opportunity for an experienced medical writer to join our Global Pharmaceutical Division. This role will sit within the global Research and Development Team. The role is home-based and there will be opportunities for professional growth. Occasional travel will be required, particularly to Berlin. The global function has group members in China, the US, Finland and Germany.
• Author study level clinical documents, clinical submission documents and reviews independently, holding responsibility for their consistency.
• Implementing the submission authoring strategy under the leadership of the MW Strategist.
• Drive 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.
• Support the MW Strategist to manage the activity, resource and time planning for the clinical part of submissions.
• Act as the medical writing expert for projects delegated from the MW Strategist, and leads the planning, the development and the implementation of the project level (one indication of one product) content strategy of clinical submission documents.
• Maintain current knowledge on all regulatory agency medical review guidelines and drug approval requirements for assigned projects.
• Mentor Associate Submission Medical Writers and Senior Scientific Medical Writers (internal and insourced) in developing expertise.
Who you are
Skills and Experience:
• A Bachelor’s and/or Master’s degree
• A PhD in natural sciences or equivalent degrees is highly desirable but not essential.
• 6 - 10 plus years’ experience in the pharmaceutical industry
• The candidate should have at least 5 years’ experience in regulatory medical writing / writing submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews etc.).
• Strong planning and project management skills and experience. A project management certification is highly desirable.
• Experience in developing clinical documents in support of regulatory submissions globally (i.e., multiple regions).
• In depth understanding of all regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (e.g. ICH, FDA, EMEA).
• 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.
• Good team player.
• Experience in supporting diverse indications is desired.
• Experience in leading teams and mentoring junior medical writers.
• Excellent working knowledge of current electronic authoring, document management and electronic regulatory submissions.
• Strong verbal and written communication skills, required to articulate concepts and ideas.
• Diplomatic, persuasive and be able to establish rapport with all key functional leaders and experts in the Pharma Research & Development organisation.
At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
At Bayer reward is important to us, employees benefit from excellent employment conditions, such as:
• Competitive salary and performance bonus
• 25 days annual leave plus bank holidays
• Private Healthcare
• Generous pension scheme
• Life Insurance
• Employee discount scheme
• State of the art offices (award winner for British Council for Offices - Best Fit Out Category 2018)
• Subsidised onsite restaurant
• Free tea and coffee, plus free fruit 2 days a week
• Free car parking
• International career prospects
Are you up for the challenge? If so, please apply below.
If you would like more information please email the team at Resourcing_uk@bayer.com