Senior Medical Writer

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Apr 27, 2021
Ref
R-126353
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Position Purpose

The Senior Medical Writer develops clinical documents for submission to global regulatory authorities. This position works directly within a multidisciplinary project team to independently write scientifically valid, complete, and consistent documents, including but not limited to clinical study protocols, clinical study reports (CSRs), investigator's brochures (IBs), briefing books, select clinical Module 2, and Module 5 summary documents. The Senior Medical Writer may be responsible for medical writing activities for one or more compounds and may contribute to major submissions. This role may also oversee junior medical writers and/or vendor medical writers.

Key responsibilities

• Ensure medical writing deliverables are of high quality and adhere to departmental procedures / practices, and industry / international standards.

• Develop regulatory documents for submission to global regulatory agencies in accordance with ICH and other global guidelines, standards, and processes, AMA Medical Writing styles, as applicable, within study/project timelines and corporate objectives.

• Actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines, and any processes required for the completion of global regulatory documents.

• Lead development and review of clinical documents including the collection, reconciliation, and incorporation of review comments required to complete regulatory documents.

• Review other functional documents associated with an assigned project(s) (eg. Statistical Analysis Plans, table shells), as appropriate.

• Provide editorial support for miscellaneous clinical documents from other Medical Writers or Clinical Team members (eg. Clinical Development Plans).

• Assist in defining and writing standard operating procedures and working practices to allow the effective and efficient preparation of quality documents.

• May participate in cross-functional process improvement initiatives.

• Global responsibilities, including participation in global teams.

Qualifications

• Bachelor's degree in life science discipline preferred.

• At least 5 years of medical writing experience in the biopharmaceutical / CRO industry or comparable experience within clinical or preclinical development.

• Understanding and knowledge of global regulatory requirements.

• Knowledge of the various phases of clinical development.

• Proficiency in organizing and communicating clinical information.

• Strong communication, organizational, time management, and project management skills.

• Strong verbal, written, and interpersonal communication skills required to work effectively in a team environment.

• Proficient in MS Word, Excel, PowerPoint.

• Experience with an electronic document management system (eg, Documentum, Viva) and document templates is preferred.

Competencies

• Strategic thinker with strong negotiating skills and resourcefulness.

• Able to manage several projects simultaneously.

• Able to critically analyze and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas.

• Strong influencing skills with the ability to lead without formal authority.

• The ability to work collaboratively within a multicultural environment.