Medical Writer

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Medical Writer**

**Position: Major Tasks**
- Acts as the medical writing expert for assigned drug projects, and leads the planning, development and implementation of the content strategy of clinical study and submission documents (with input from appropriate expert functions).
- Drives the design of clinical study and 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 drug projects.
- Leads the development of the project level data presentation strategy and messaging standards.
- May lead the team of medical writers supporting the clinical submission documents for assigned drug projects.
- Independently authors submission documents and works with assigned Medical Writers and other submission team experts in developing and implementing the submission authoring strategy for all clinical documents.
- Works with Medical Writing Oncology management to develop and implement authoring resource plans for all clinical submission documents of assigned drug projects.
- Maintains current knowledge on all regulatory agency medical review guidelines and drug approval requirements for assigned projects.
- Mentors Medical Writers in developing expertise in managing and writing and submission documents.

**Position: Skills**:

- PhD is highly preferred.
- The incumbent must possess strong planning and project management skills and experience. Project management experience 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 experience in leading medical writing teams and mentoring Medical Writers for at least2 years.
- 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.
- The incumbent must have an in-depth understanding of regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (e.g. ICH, FDA, EMEA).
- 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

**Your Application**:
Be You at Bayer where you have the opportunity to be part of a culture influencing Health for all and Hunger for none.

To achieve our vision we see reward for all our employees as incredibly important and include the following list of benefits and working conditions:

- Competitive salary and performance bonus.
- 28 days annual leave plus bank holidays.
- Private Healthcare, generous pension scheme and Life Insurance.
- Employee discount scheme.
- State of the art offices.
- International career possibilities.
- Flexible and remote working.

**The best possible work-life balance is of great importance to us, which is why we support flexible hybrid working model.**

LI-UK

Hybrid

**Location**:
United Kingdom : Berkshire : Reading

**Division**:
Pharmaceuticals

**Reference Code**:
811398