9 days old

Senior Medical Writer

Kelly Services
Malvern, PA 19355
Kelly Services Outsourcing & Consulting Group is seeking a Senior Medical Writer in Global Regulatory Medical Writing for an open-ended assignment in Frazer, PA. This position comes with benefits and requires all work be done onsite.

The Senior Medical Writer provides intermediate medical writing support to Clinical Specialty Development (and other departments as appropriate) in the production of clinical research documentation in support of drug development, product registrations, and product marketing.

**Essential Functions:**

+ Writes and/or edits clinical regulatory documents (generally clinical study protocols/amendments, clinical study reports, and Investigators Brochures and briefing documents)

+ Preferably demonstrated experience with Clinical Pharmacology documentation and early clinical phase summary documents.

+ Ensures that these documents are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.

+ Prepares other documents for regulatory submissions

+ Advises Clinical (and other) staff on the organization and presentation of information within documents, as well as the design and format of data displays.

+ Ensures quality assurance of own documents

+ Provides leadership/strategy at the cross-functional study-team level for individual documents

+ Participates significantly in meetings at the document-team level

+ Contributes to the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents

+ Works successfully in a cross-functional global team

+ Communicates information clearly and concisely


+ PhD/PharmD in life sciences (or other related field) with a minimum of 2 years of experience related to medical writing, Masters in life sciences (or other related field) with a minimum of 3 years of experience or Bachelors degree with a minimum of 5 years of experience. Preferably education in Pharmacology or Pharmacy.

+ Excellent English, both written and spoken.

+ Intermediate writing and editing skills and competence in the use of relevant software applications, and using templates, and other electronic formats

+ Intermediate knowledge of government regulations pertaining to drug development and understanding of the Companys products and standard operating procedures (SOPs)

+ Ability to organize and present information and to communicate regulatory medical writing processes and technical and editorial standards

+ Good organizational/planning and problem-solving skills at the document level

+ Excellent presentation and written communication skills

+ Works successfully with an intermittent level of direct supervision

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

**This position comes with enhanced benefits which include:**

+ 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*

+ Paid holidays

+ Paid sick days and vacation days*

**Perks of being a Kelly employee:**

+ Weekly electronic pay

+ Access to more than 3,000 online training courses though Kelly Learning center

+ Online application system

+ Never an applicant fee

*benefits to be received upon meeting eligibility requirements

**Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at**

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect
with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
Posted: 2019-01-11 Expires: 2019-02-11

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Senior Medical Writer

Kelly Services
Malvern, PA 19355

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