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10 days old

Medical Writer - Regulatory/Medical Device

Kelly Services
North Wales, PA 19477
Kelly Services Outsourcing & Consulting Group (OCG) is seeking a Medical Writer with a regulatory/medical device background for a one-year assignment in Spring House, PA. This assignment comes with benefits and has strong potential to extend.



The Medical Writer will write manuscripts, abstracts, posters or regulatory documents as assigned and support assigned Medical Affairs writing projects (e.g., for Phase 3b/4 post marketing or investigator-initiated studies or registries). In addition, may write abstracts, posters and/or manuscripts for clinical projects (Phase 1-3) with the help of other functional areas.





Writing may include but is not limited to:




+ Provide writing support for assigned documents and/or therapeutic area (TA) teams. Documents assigned may include but are not limited to abstracts, posters, manuscripts, clinical study reports, protocols and/or protocol amendments. May assist with electronic submissions of manuscripts and/or abstracts.

+ Write, edit, and revise abstracts and/or manuscripts in line with company SOPs, ICJME guidelines and GPP. As agreed upon by the lead author, develop any or all of the following: manuscript outline, manuscript shell, draft manuscripts, as well as various other written sections of publications.

+ Write, edit, and revise assigned Medical Affairs regulatory documents (e.g., Annual Registry reports, Post-authorization safety study (PASS) reports, annual interim study reports, briefing booklets, protocols and/or protocol amendments) according to the International Conference on Harmonization (ICH) guidelines and US FDA/regulatory authority requirements.

+ Assist in table and figure mock-up development. Review and interpret data and source documents for information required for document development.

+ Identify and resolve, with the help of other functional areas, clinical and statistical issues in the interpretation of clinical data.

+ Demonstrate mastery of relevant publication and regulatory document guidances including but not limited to: ICJME, GPP, Consort Guidelines, AMA Manual of Style, Council of Biology Editors, as well as ICH and other regulatory guidelines pertaining to study protocols and clinical study reports.

+ May perform other duties as assigned.

+ Manage assigned writing projects may include but is not limited to:

+ Provide medical writing support and representation to an assigned TA publication and/or study team.

+ Manage document development timelines to facilitate timely submission.

+ Maintain annotated versions of documents and facilitate review cycles.

+ Facilitate, collate, and adjudicate author and reviewer comments.

+ Adjudicate and address quality control (QC) review.

+ Verify completion of SOP-mandated approvals (e.g., Legal, Patents, Regulatory Affairs, etc.) prior to manuscript submission.

+ Other duties as assigned





**Educational Requirements:**




+ BA/BS required - must be scientific or clinical; MA/MS/MBA/Doctorate highly desirable

+ Minimum of 8 years related experience, preferably in a regulatory or document preparation context.




**Competency Requirements:**




+ Integrity / Credo-based Actions

+ Strategic Thinking

+ Big Picture Orientation w/Attention to Detail

+ Intellectual Curiosity

+ Collaboration and Teamwork

+ Sense of Urgency

+ Prudent Risk Taking

+ Self-Awareness/Adaptability

+ Results/Perf Driven




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 gail.robilliard@kellyservices.com.**






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




The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.


Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.


The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


**AboutKelly Services** ****




As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-01-11 Expires: 2019-02-11

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Medical Writer - Regulatory/Medical Device

Kelly Services
North Wales, PA 19477

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