Principal Medical Writer

IQVIA•Durham, NC

About The Position

Acts as Lead Medical Writer on any type of writing project and can advise others on any type of document. Can act in a customer account management capacity and present, discuss, and answer questions on overall Medical Writing global capabilities to prospective customers. Performs Senior Review of all types of medical writing deliverables. Provides feedback and guidance to staff and identifies and acts upon department training needs. Communicates various medical writing topics to a broad audience and identifies appropriate parties to be included. Negotiates timelines and discusses/resolves customer comments. Keeps abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practices (GCP), along with developments and advances in drug development/medical and/or technical writing. Essential Functions Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer. Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests. Use experience and initiative to tackle new/unusual document types and customer requirements. Chair meetings and resolve conflict using advanced negotiation and conflict resolution skills. Prepare, present and respond in bid defense meetings and discussions. May design training materials and input into generic training plans for staff. Proposes topics for and prepares and delivers knowledge-sharing sessions for the global team. May plan and deliver workshops or presentations on Medical Writing topics, e.g. for a conference. May act as project manager for a large Medical Writing program, including more than one document type and/or region and/or limited other functions. May coordinate Medical Writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, customer liaison, and tracking. Complete project finance activities, including monitoring and forecasting budgeted hours. Independently propose, review and approve budgets and assumptions for a range of project types within remit. May take on a larger partnership lead role. May propose and/or lead small global Medical Writing initiatives or act as a regional Medical Writing representative on a cross-functional initiative. May represent Medical Writing as reviewer for cross-functional Standard Operating Procedures (SOPs) owned by other operations. May make process improvements to enhance performance. Qualifications Bachelor's Degree Bachelor's Degree in life sciences related discipline or related field Master's Degree Master's Degree in life sciences related discipline or related field Ph.D. Ph.D. in life sciences related discipline or related field Typically requires at least 8 years of highly relevant experience and related competency levels. In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in documents. Good understanding of common statistical methods used in clinical trials and/or interpretation of their results. Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output. Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.

Requirements

Bachelor's Degree Bachelor's Degree in life sciences related discipline or related field
Master's Degree Master's Degree in life sciences related discipline or related field
Ph.D. Ph.D. in life sciences related discipline or related field
Typically requires at least 8 years of highly relevant experience and related competency levels.
In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in documents.
Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.
Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output.
Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
Extensive experience in preparing CSRs and protocols independently to a consistently high standard, regardless of complexity or challenges.
In depth knowledge of drug development, medical writing, and associated regulations.
Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
Excellent written and oral communication skills including grammatical/technical writing skills.
Excellent attention to detail and accuracy.
Confident and effective communication and negotiation skills with customers and project managers.
Ability to set a positive example to staff in attitude to customers and colleagues and communication style.
Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and colleagues.
Demonstrated ability to handle unfamiliar situations or document deliverables.
Demonstrated abilities in collaboration with others and independent thought.
Demonstrated ability to influence others in global and/or cross-functional or customer discussions.
Demonstrates good judgement in requesting input from senior staff.
Ability to establish and maintain effective working relationships with coworkers, managers and customers at a senior level.
Experienced and effective in providing feedback and guidance to staff.
Ability to effectively manage multiple tasks and projects.
Decisive amongst competing priorities.
Confident in raising and discussing sensitive topics without management intervention.
Ability to proactively identify potential issues affecting other functions on the project teams and facilitate appropriate communication
Identifies creative solutions to challenges that are acceptable to IQVIA and customers.
Must be computer literate.

Nice To Haves

Experienced in preparing CTDs and/or tackling new/unusual document types/customer requirements.

Responsibilities

Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.
Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests.
Use experience and initiative to tackle new/unusual document types and customer requirements.
Chair meetings and resolve conflict using advanced negotiation and conflict resolution skills.
Prepare, present and respond in bid defense meetings and discussions.
May design training materials and input into generic training plans for staff.
Proposes topics for and prepares and delivers knowledge-sharing sessions for the global team.
May plan and deliver workshops or presentations on Medical Writing topics, e.g. for a conference.
May act as project manager for a large Medical Writing program, including more than one document type and/or region and/or limited other functions.
May coordinate Medical Writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, customer liaison, and tracking.
Complete project finance activities, including monitoring and forecasting budgeted hours.
Independently propose, review and approve budgets and assumptions for a range of project types within remit.
May take on a larger partnership lead role.
May propose and/or lead small global Medical Writing initiatives or act as a regional Medical Writing representative on a cross-functional initiative.
May represent Medical Writing as reviewer for cross-functional Standard Operating Procedures (SOPs) owned by other operations.
May make process improvements to enhance performance.