Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. 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.
Assoc Dir Scientific Med Writer
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Associate Director Scientific Med Writer, are to:
- Independently author submission documents and implement the submission authoring strategy under the leadership of the Submission Medical Writer;
- Drive the design of all assigned project level submission documents in support of the Clinical Development Plan (CDP) under the leadership of the Submission Medical Writer;
- Validate the individual study protocol design and clinical study report (CSR) key messages;
- Contribute to the project level data presentation strategy and messaging standards under the leadership of the Submission Medical Writer;
- Mentor Senior Scientific Medical Writers and Scientific Medical Writers in developing expertise in writing submission documents.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Bachelor’s degree (scientific discipline strongly preferred) with at least eight years of pharmaceutical industry experience or a Master's degree in the life sciences and at least seven years of experience in the pharmaceutical industry;
- At least five years of experience in regulatory medical writing, three of which should be in writing the submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews, etc.), preferably in the area of oncology;
- Have extensive experience in writing clinical documents in support of regulatory submissions globally (i.e. multiple regions);
- Have relevant experience in managing and mentoring medical writers and must have successfully led medical writing teams developing the clinical sections of CTD dossiers;
- Have a thorough knowledge of the pharmaceutical industry, including understanding the drug development process and associated documents and regulations;
- Specific knowledge of the clinical study protocol and clinical study report development process, regulatory and drug safety requirements, and clinical data management and statistical processes/functions;
- Have an in depth understanding of all applicable scientific and regulatory guidance, standards and requirements pertaining to regulatory medical writing world wide (e.g., ICH, FDA, EMA, CFDA);
- Have an excellent working knowledge of current electronic authoring, document management and electronic regulatory submissions, tools and standards;
- Demonstrate outstanding communication skills (fluency in English, written and verbal) required to articulate concepts and ideas;
- Be diplomatic, persuasive and be able to establish rapport with all key functional leaders and experts in the Oncology SBU organization;
- Ability to establish internal and external collaborations, including commitment towards external visibility;
- Native verbal and written English communication skills.
- Ph.D. in the life sciences and at least five years of experience in the pharmaceutical industry is;
- Have extensive experience in writing clinical documents in support of regulatory submissions globally (i.e. multiple regions) in the area of oncology.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer active employees are required to disclose their vaccination status and if fully vaccinated, provide proof of vaccination status before participating in approved activities for fully vaccinated employees. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, if candidates are invited on site as visitors for in person interviews, they must provide proof of being vaccinated and comply with all safety protocols.
State: New Jersey
Reference Code: 531684
Functional Area: Medical Affairs & Pharmacovigilance
Entry Level : Professional