Medical Writing Manager

2 months ago

Dublin, Ireland Gilead Sciences Ireland UC Full time

Description


 

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need including virology, oncology, and inflammation. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world.

Gilead has established employee resource groups to support , and provides a competitive benefit package including flexible work options and exceptional support for the family and the individual.

Medical Writing is a global, dynamic, and diverse team of highly skilled professionals. We work collaboratively to advance the strategy and create high-quality documents for successful regulatory submissions, by bringing our passion for science, discovery, and innovative strategic thinking into our daily work. Medical Writing resides within Regulatory Affairs. We are dedicated to attracting new talent with diverse backgrounds and experiences and committed to providing individual development and growth opportunities while promoting a healthy work-life balance. 

The Role:

We have an exciting and unique opportunity for a Medical Writer to join our dynamic team at the Manager level. You will prepare clinical documentation for global regulatory submissions. You will have the opportunity to develop expertise in the preparation of a wide range of documents. You will work with cross-functional teams (eg, Regulatory Affairs, Clinical Research, Clinical Operations, Clinical Pharmacology, Patient Safety, and Clinical Data Science) to deliver documents on time and per team expectations and drive document strategy for Medical Writing.

Key Responsibilities:

Author clinical/regulatory documents such as clinical study reports (all phases), protocols and amendments, and investigator brochures according to regulatory requirements and Gilead internal document standards with some input from a more senior writer. Work in tandem with a more senior writer on other documents types such as integrated clinical summaries, pediatric investigation plans, or regulatory responses. May participate in regulatory submission teams, providing guidance for optimal presentation of data to achieve document intent. May manage document timeline and resource planning with input from a more senior medical writer. Participates in development/improvement of document standards, templates, and processes and other non-medical writing activities.

You Will Need:

The ability to understand the needs of a team and manage their expectations and use various communication styles to work effectively with teams The ability to balance integrity and efficiency when managing attention to detail Knowledge of regulatory document requirements/guidelines Knowledge of pediatric plans, eg, PIPs, PSPs, PPSRs Proficiency in the use of Microsoft Office and document management systems Bachelor’s degree, or local equivalent, or relevant experience Relevant experience includes clinical research and development, regulatory affairs, or related industry/academic experience, with direct experience preparing clinical/regulatory documents in a medical writing/clinical submissions environment.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.


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