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Senior Medical Writer (Medical Writer III-CDS)

Covance 4/10/2019 12:24:33 PM
JOB ID: 30262 Category: Medical Writing
Durham, North Carolina



Job Overview

A career at Covance provides our employees the unique opportunity to make an immediate impact and difference in our patient's lives. Joining Covance will offer a rewarding career, a chance to work in an energetic & team oriented work place, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you'll be empowered to own your career journey with mentoring, training and personalized development planning. As a Covance employee, your work will be meaningful, the patient outcomes are real, and the results are lasting. Our mission is to help our clients bring the miracles of medicine to market sooner.

We are currently hiring a Senior Medical Writer (Medical Writer III). This position can be home or office based in the US.

Responsible for the production of scientific publications and other documents (e.g., abstracts, posters, manuscripts, etc. Responsible for preparation and coordination of clinical study protocols and clinical study reports (CSRs), and other documents as needed. Provide support for and participate in development of submission level documents under guidance of senior staff. ). Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate. Oversees and coordinates activities of other writers on higher complexity narrative projects. Ensure timely delivery of high quality documents to internal customers and Sponsors. Provision and development of intra- and inter-departmental training. Works with the management team to provide guidance and mentoring to Medical Writers to ensure best working practices are maintained. Scientific presentations both internally within Covance and externally (e.g., conferences). Represents the company at scientific meetings and meetings with clients. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.

* Write and coordinate the development of protocols, CSRs or other clinical documents including those of a more complex nature
* Provide support in development of submission level documents under guidance of senior staff
* Oversees management and coordination of complex narrative projects
* Produces scientific papers, abstracts and/or posters, and presentations.
* Responsible for all medical writing aspects of project development and coordination, adherence to timelines and budget
* To prioritize and plan workload to a high standard. Effectively manage multiple assignments in parallel
* Prepare documents in accordance with Covance/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines
* Review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.
* Act as medical writing contact for major clients and partners
* Keep up to date with developments in Medical Writing
* In consultation with more Experience d staff, show initiative and ability to deal with complex project situations
* Inform management of medical writing problems promptly and propose solutions
* Provide advice on Medical Writing issues to project team members (internal and external) and help to resolve problems
* Contribute to Medical Writing initiatives to develop and improve processes
* Mentor and provide guidance and training to other medical writing staff
* Provide peer review and input on deliverables prepared by colleagues
* Provides scientific leadership and support to colleagues in the data management and reporting team
* Provide support for Business Development opportunities such as time and cost estimates, attendance at client bid defense meetings, industry conferences
* Review Covance SOPs and associated documents
* Represent department in audits and inter-department working groups
* Comply with Covance internal processes and procedures
* Performs other duties as assigned by Management



Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred


Minimum Required:

* Typically minimum 4 years medical writing Experience including 2 years as medical writing project lead
* Excellent command of written and spoken English
* Excellent written and verbal communication skills
* In-depth knowledge of MS Word
* Excellent organizational and time management ability
* Detailed knowledge of ICH guidelines applicable to medical writing
* Good understanding of medical/scientific terminology and Experience in data analysis and interpretation

Position Type: Full-Time

Location: Durham, NC - North Carolina


Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).