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Medical Writing Manager, Remote, EU

Employer
Worldwide Clinical Trials
Location
HOMEWORKING, Nottingham, United Kingdom
Salary
Competitive
Start date
16 Oct 2019
Closing date
28 Oct 2019

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Discipline
Medical Communications, Medical Writing
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

SUMMARY: The Medical Writing Manager is responsible for managing medical writing activities in accordance with client specifications in a timely, accurate, and efficient manner, within budget and to written, scientific, and ethical standards in accordance with regulatory requirements and WCT standard operating procedures (SOPs).

LOCATION: Home based role, Europe.

RESPONSIBILITIES:
Tasks may include but are not limited to:
  • Manage the process and delivery of study documents such as protocols, informed consent documents, clinical study reports (CSRs), patient narratives, and other study documents.
  • Manage the process and delivery of product documents such as investigator drug brochures, summary documents, and other documents.
  • Manage direct reports (internal employees or vendors), as assigned.
  • Perform review and QC of documents, as needed.
  • Manage and direct interactions between appropriate team members to ensure publishing of documents, as needed.
  • Review timelines and support timeline negotiations to ensure milestones can be achieved as expected.
  • Evaluate, identify, and appropriately communicate risks associated with document delivery and propose mitigation plans. 
  • Define medical writing resource needs and lead cross functional coordination of both internal and external resources, inclusive of sub-contractors, in order to manage medical writing deliverables.
  • Advise project team and clients on medical writing-related issues.
  • Ensure completion of project-specific and company training for direct reports, as assigned.
  • Immediate supervision of employees; prepare and conduct performance appraisals and salary reviews and apply company policies.
  • Work with leadership in other functional areas on the continuous development/improvement of medical writing processes to ensure that work is uniform, complete, and managed appropriately.
  • Serve as a liaison with Business Development and Bids/Contracts for client presentations and proposal development for medical writing.
  • Assist in resource utilization, policy development, and implementation of goals within medical writing.
OTHER SKILLS AND ABILITIES:
  • Expert knowledge of medical writing principles and application.
  • Excellent written and spoken English, able to accurately interpret data and express findings in a clear and concise written manner.
  • Strong leadership, project and time management, decision making, and organizational skills.
  • Knowledge of budgeting, forecasting, and resource management.
  • A relationship builder who is able to work effectively in a matrix organization.
  • Superior knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9).
  • Skilled in process improvement, especially as it applies to medical writing.
  • Strong marketing and negotiation skills.
REQUIREMENTS:
  • University/college degree (life science or related allied health profession) and American Medical Writers Association Certification or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities.
  • Graduate degree preferred.
  • Minimum of 8 years of clinical pharmaceutical industry experience including medical writing.
  • At least 2 years in a management position.
  • Thorough knowledge of applicable regulatory guidelines related to medical writing.
  • A demonstrated track record of success in medical writing and managing vendors.
  • Available for domestic and international travel, including overnight stays (valid passport).
  • Broad knowledge of drug development process.
  • Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

#LI-EW1
 
 

Description Key Responsibilities Benefits

Company

Find out more about working for our company

Worldwide Clinical Trials -hub-button

Brief Company Description; 

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

 

Company info
Website
Mini-site
Worldwide Clinical Trials
Telephone
+44 115 956 7711
Location
1st Floor Waterfront House
Beeston Business Park
Beeston
Nottingham
Nottinghamshire
NG9 1LA
United Kingdom

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