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Associate Director Medical Writing

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Start date
Nov 17, 2022

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Discipline
Clinical, Medical Writing
Required Education
Masters Degree/MBA
Position Type
Contract
Hotbed
Pharm Country, Best Places to Work
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Job Details

Job Description

Please note that CSL offers flexible agile work policies – remote working available

The Associate Director is a key leadership position responsible for determining and driving the medical writing strategy for one or more Programs within Clinical Development.


You will be accountable for the efficient preparation of high quality, strategically aligned medical writing deliverables that support the clinical development, safety, and regulatory requirements of clinical programs. They are responsible for the messaging strategy across a program of work, for their ability to deliver the information required by the target audience (i.e., regulatory authority) in a compelling fashion with accuracy and consistency.


This role can have global responsibilities with participation in global teams and interaction with regulatory agencies in multiple regions.

• This role reports to the Director of Medical Writing

1.

Key accountabilities:
• Maintain a collaborative and strategic partnership with, Global Clinical Program Directors and Clinical Safety Physicians to ensure understanding of Clinical Development strategy for the Program.
• Leads cross-functional teams to develop a messaging strategy across a program of work (e.g., building a clinical submission)
• The efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines
• Resource planning and resource allocation.
• Project Manage Medical Writer(s) within the Program. Coach, train and mentor staff, thereby contributing to successful clinical development, product registration in key regions and commercialization of new compounds, including important lifecycle management work
2.
Drives and develops the messaging strategy within the therapeutic area to ensure effective communication underpins successful clinical development.
• Responsible for aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continuing through study level documents to final program level deliverables (i.e., regulatory submission or publication of key journal articles for a publication plan).


• Interfaces with Global Therapeutic Area Heads, Global Clinical Program Directors and Clinical Safety Physicians to ensure that the communication needs for clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical development process.


• Analyses proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (i.e., regulatory authority) in a compelling fashion with accuracy and consistency.


• Understands where all intended messages will be located across individual documents within a clinical program, and ensures alignment of messages across documents.


• Understands issues affecting the design of clinical development strategy, and understands how study design, data capture and statistical analysis plan design will affect downstream documents.


• Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data.


3.
• Accountable for medical writing deliverable quality and ensures adherence to departmental procedures / practices, and industry / international standards.
• Responsible for the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables.
• Cultivates an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks.
• Responsible for continual improvement of in-house medical writing.
• Provides expert medical writing support to other CR&D and CSL groups where required.

4.
• In collaboration with Director, Medical Writing and Disclosure, ensures appropriate medical writing support for the clinical programs including forecasting, budgeting, resource planning and resource allocation
• Responsible for building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc.) to ensure an effective, efficient, productive and professional working relationship. Participates in vendor governance.
• Participant in bid defense, contract development, work alignment and / or operation meetings.
Position Qualifications and Experience Requirements: Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position.

Education
Bachelor’s Degree minimum requirement

Post-graduate qualifications, preferred


Experience
• A minimum of 5 years medical writing experience within the biopharmaceutical industry or a contract research organization.
• A comprehensive understanding of the clinical development process, including the documents that are required at each stage.
• A comprehensive understanding of medical writing processes, standards and issues.
• Demonstrated track record in cross-functional, multicultural and international clinical trial teams.
• Excellent verbal, written and presentation skills.
• Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
• Prior experience with submissions in Common Technical Document (CTD) format.
• Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management).
• Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.


4
Competencies
• Ability to think strategically; demonstrated negotiating skills and resourcefulness.
• Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
• Strong influencing skills, able to lead without formal authority.
• Strong interpersonal skills; proven track record of staff management and effective leadership.
• Demonstrated ability to drive performance – holds others accountable for high standards and clarifies what needs to be accomplished and the consequences for the individual and / or organization.
• Demonstrated ability to manage several projects simultaneously.
• Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas.
• High degree of influencing skills in shaping and developing content and wording.
• Demonstrated ability to work collaboratively; multicultural sensitivity, builds positive and productive relationships, seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions / proposals.
• Successful track record of leading complex clinical / regulatory writing projects.
• Can manage uncertainty and shifting priorities and timelines.
• Demonstrates learning agility.
• An excellent understanding of all aspect of ICH-GCP; keen insight on external clinical publication practices and standards (ICMJE, AMA, GPP).
• Excellent organizational and time management skills.
• Attention to detail.

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About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.

Do work that matters at CSL Behring!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Find Us
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States
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