Job for Medical Writer in Abbott

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

Post : Medical Writer

JOB DESCRIPTION:
Core Job Responsibilities:

Responsible for the creation and oversight of project plans, which includes timeline management, preparation of business-critical regulatory documents, and the quality of key deliverables.
Independently produces high quality, medically accurate analyses of clinical and post-marketing data for internal and external customers in written format under the direction of the Senior Medical Writer.
Critically reviews and edits the analyses of the Scientific Writer, assuring that documents are of the highest quality, appropriate for the designated audience, and reflect current medical standards.
Performs job responsibilities in collaboration with the Senior Medical Writer, Medical Safety Experts, management, and cross-functional areas within Medical Affairs, Regulatory Affairs, Clinical Development and the Product Safety Teams.
Expert on applicable writing styles and standards, ensuring deliverables meet organizational, regulatory, and customer needs.
Utilizes a variety of resources to support conclusions/assumptions and demonstrates sound medical judgment regarding causality based on the application of clinical experience, standards of care, and regulatory guidelines.
Actively contributes to minimizing patient and product risk by conducting pharmaceutical and medical assessment of information on drug risks including adverse reactions, drug interactions, toxicity and medication errors during periodic report preparation. This includes the consideration if safety data qualify as a new safety signal or as a new identified or potential risk, or may potentially alter any previous signal or risk assessments.
Proactively understands regulatory framework, trends & requirements related to Pharmacovigilance, clinical studies and global drug development.

Candidate Profile :
M.D. or Ph.D. in a Health Sciences Field, preferably physician, veterinarian, or pharmacist

Minimum Experience/Training Required:

Minimum 3 years industry experience in Pharmacovigilance, Strategic Medical Affairs or Clinical Development.
Understanding and initial experience in Pharmacovigilance in the pharmaceutical industry or academia or equivalent.
Understanding of medical conditions and disease state entities, able to critically evaluate medical data.
Experience in preparation of periodic safety reports.
Experienced professional operating within the international arena, and working across functional areas.
Proficiency in the use of Microsoft Excel, Word, Power Point, Outlook, e-room technology, and good electronic Common Technical Document (eCTD) knowledge and formatting skills (e.g. ISI Writer).
Very good communication and presentation skills (oral and in writing) in English.