Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Position Overview:

In this role, you will provide high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. As a Senior Medical Writer, you will provide technical consultation and advice on strategy, regulations and industry best practices.

• Ability to effectively manage medical writing projects to deliver quality products in agreed timelines by demonstrating subject matter and therapeutic area expertise.
• Collaborating with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
• Independently researches, writes, and edits standard medical information writing deliverables across various therapeutic areas. Independently writes more complex medical writing deliverables. Examples may include global or regional standard response documents, custom responses, and FAQs. Provides senior review of documents and training/mentoring for other writers.
• Manages all aspects of planning, organizing, and executing projects without supervision, including: developing project timelines, standards, budgets, forecasts and contract modifications. Liaises with other functional units as necessary. Identifies and escalates out-of-scope project activities in a timely manner and proposes solutions.
• May manage several long-term projects concurrently.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise.
• Normally receives little instruction on day-to-day work, general instructions on new assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Represents the department as a prime contact on projects including Project Launch Meetings, Review meetings, client audits, bid defenses, and capabilities presentations. Establishes and develops client relationships; independently initiates and leads interactions with clients. Assists with business development and development of budgets and proposals.

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years') or equivalent combination of education, training, & experience.
• Experience working in the pharmaceutical/CRO industry preferred.
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.
• Ideally a pharmacy or nurse background.
• Medical information experience.

• Aptitude to accurately work with, manipulate and format numbers, numerical information, and data of various types to provide evidence, information and insights.
• Demonstrated ability to communicate and document information effectively in written English, including the ability to produce reports, documents, emails and other written pieces which are well-organized, free from errors and are appropriately adjusted to the characteristics and needs of the audience.
• Able to analyze complex issues and evidence, identify cause-effect relationships and generate effective solutions.
• Able to create, communicate and manage effective project plans that support the delivery of overall project objective(s); to identify, manage and guide project team members; to monitor and report on progress in an organized fashion; and to deliver the required results.
• Demonstrates sound professional judgment in analyzing, responding to, and resolving enquiries, issues and escalations.
• Able to facilitate the resolution of conflict among team members and clients, through listening and understanding the cause(s), gaining agreement on an appropriate course of action, and following up to ensure a successful outcome.
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).