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.
Medical Writing Strategist
Major tasks and responsibilities:
• An expert advisor for the entire oncology area on complex scientific and regulatory topics related to study and project level clinical document development in all indications for the assigned clinical program(s)
• The oncology Medical Writer compound expert and is responsible for planning, developing and implementing scientific strategy and content for all assigned clinical documents in collaboration with other expert functions (e.g., biostatisticians, regulatory, clinical operations, etc) as required
• The driver for the overall design of clinical submission documents, validates individual study protocol design, key scientific content for clinical study reports and other regulatory documents.
• A collaborator with strategic partners/stakeholders (e.g., Global Regulatory Strategist (GRS), Clinical Development Lead (CDLs), Project Statisticians, and other relevant functions) to develop project level strategy for data presentation and dissemination for the assigned clinical program(s).
• A subject matter expert in MW, remaining current on all relevant scientific topics, regulatory agency medical review and submission guidelines and drug approval requirements for oncology products. Provides strategic input on the interpretation and implementation of regulatory guidelines for the development of company-internal processes, templates and scientific content needed for the development of all clinical document types.
• A representative of the SBU MW function for all aspects of oncology clinical development programs and products to internal and external stakeholders (e.g., regulatory agencies, industry and healthcare associations, collaborations/business partners, etc).
• A coach and mentor for Submission Writers and Senior Medical Writers (internal and outsourced).
Qualifications, Skills and Experience?
- This position requires a Master’s degree in natural sciences and a minimum of 10 years experience in the pharmaceutical industry, or a PhD in natural sciences and a minimum of 8 years experience in the pharmaceutical industry
- The candidate should have at least 8 years experience in regulatory medical writing, 6 of which should be in writing submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews, etc.) in the area of oncology. PhD is highly preferred.
- The incumbent must have extensive experience in writing clinical documents in support of regulatory submissions globally (ie multiple regions) in the area of oncology
- The incumbent must have relevant experience in managing and mentoring medical writers and must have successfully led medical writing teams developing the clinical sections of CTD dossiers
- The incumbent must have a thorough knowledge of the pharmaceutical industry, including understanding the oncology 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 is required.
- The incumbent must have an in depth understanding of all applicable scientific and regulatory guidance, standards and requirements pertaining to regulatory medical writing in oncology world wide (e.g…ICH, FDA, EMA, CFDA).
- The incumbent must also have an excellent working knowledge of current electronic authoring, document management and electronic regulatory submissions, tools and standards.
- The incumbent must demonstrate outstanding communication skills (fluency in English, 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 Oncology SBU organization. Ability to establish internal and external collaborations, including commitment towards external visibility is required.
- Excellent verbal and written English communication skills are essential.
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.
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 and Life Insurance
- Employee discount scheme
- State of the art offices (award winner for British Council for Offices, Best Fit Out Category 2018)
- International career possibilities
- Flexible working
Are you up for the challenge? If so, please apply below.
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 275967
Functional Area: Medical Affairs & Pharmacovigilance