Senior Manager, Medical Writing - Remote job in Cambridge, USA

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First Name*

Last Name*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Medical Communications, Medical Writing, Account Management

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Senior Manager of Medical Writing with a global biopharmaceutical company located remotely. As the Senior Manager, you will work with global colleagues across R&D to ensure high quality documents are produced in the timeframe provided.

Job Responsibilities:

Write and edit clinical regulatory documents companywide for sense, clarity, accuracy, and effectiveness.
Work with lead writer and project team to develop document messages and data presentations within submission timelines to meet company objectives.
Provide writing support for a wide range of documents, including investigator's brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs.
Work with the lead writer to create, manage and communicate the document timeline to ensure all reviews are completed in predetermined timeframe.
Ensure that documents comply with International Conference on Harmonisation guidelines, company SOPs, and Good Clinical Practices.

Skills and Requirements:

BA/BS or higher required
At least 4 years of writing experience in the pharmaceutical industry
Ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
Experience with a variety of regulatory and clinical documents
Experience in a matrix environment
Excellent written and oral communication skills and demonstrated problem-solving abilities
Ability to handle multiple projects and short timelines
Ability to work cooperatively with colleagues in a wide range of disciplines
Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents

If you are having difficulty in applying or if you have any questions, please contact George Watson at (+1) 929-223-4835 or g.watson@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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