United BioSource Corporation.

Sr Medical Writer

3 days left

Location
Kansas City, US
Salary
Competitive
Posted
20 Sep 2019
Closes
20 Oct 2019
Ref
1560
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Brief Description:

Coordination of medical writing activities for Medical Writing projects. Independently write, edit, and compile high-quality clinical/regulatory documents.

Specific Job Duties:

• Preparation and management of departmental deliverables, such as clinical protocols (required), clinical study reports (required), KABs, REMS, IND, NDA and CTD summary documents, investigator brochure development and manuscripts for publication

• Represent Medical Writing on UBC and client project teams for project planning, timeline development, and resource management

• Participate in proposal preparation and resource allocation

• Proactively manage timelines for medical writing deliverables

• Represent Medical Writing at bid defenses

• Assist in the development of key messaging

• Coordination/consultation with other UBC departments such as SERRM, Data Management, Programming, Biostatistics, Quality Assurance, and Project Management on Medical Writing projects

• Develop/maintain medical writing SOPs

• Perform quality control and peer reviews of documents and assess compliance with regulatory requirements, clients requests, and SOPs

• Inform Medical Writing Department head of potential problems/challenges

• Conduct comment resolution meetings Other duties as assigned

Requirements:

• Bachelor's degree in biological sciences or equivalent

• At least 5+ years' experience in medical writing within the pharmaceutical/CRO industry

• Advanced word processing skills (Microsoft Word) including proficiency with tables

• Strong organization and prioritization skills

• Attention to detail/high degree of accuracy

• Ability to clearly and effectively communicate and interact with clients

• Strong analytical, problem-solving, and data interpretation skills

• Excellent communication skills

• Excellent interpersonal skills

• Ability to work both independently and as a part of a project team

• Exposure and familiarity with relevant ICH and FDA guidelines

• Understanding of pharmaceutical industry templates and styles

ABOUT UBC

United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.

While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.

Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
You can find out more by visiting

www.ubc.com

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