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Sr. Technical Writer

Kelly Services

Cambridge, MA
Job Code:
Kelly Services
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Job Details

Job Title Sr. Technical Writer

Jobid US41L7BS_BH1433782

Location: Cambridge, MA, 02238, USA

Description Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Technical Writer** at a prestigious Fortune 500® company working in **Cambridge, MA or Remote.**

**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” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( ) however your resume must be received via the “Submit Resume” button included within.

**Job Title: Technical Writer**

**Pay: $55 per hour depending on experience**

**Position Summary** :
100% Remote OK
2 Candidates Needed

**Must have Pharma experience**

Standard Operating Procedure Technical Writer for Global Patient Safety Evaluation:
Case Processing and Risk Management

Under limited supervision, the Writer is responsible for and participates in projects involving the revision of existing SOPs or development of policy and procedure documents to effectively meet operational and regulatory requirements. Performs related regulatory compliance research, analysis, and evaluation activities, as needed. Acts as a project leader for all related work as the SOP designer.
Duties and Responsibilities
• Interviews subject matter experts (SMEs), observes work processes, and communicates with business leaders and staff to research and analyze information required for the development, update, or consolidation of policies, procedures, forms and/or training documents
• Develops documents in accordance with Company standards and templates.
• Prepares, packages, and presents draft documentation to management, compliance/risk, subject matter experts, and appropriate lines of business for review and publication approval.
• Drafting process maps to illustrate process flow as it relates to the procedures
• Works with Quality Document Management team to secure, assemble, and archive accumulated documentation and approvals for regulatory compliance purposes.
• Acts as a project leader in all phases of project execution and implementation, and ensures all related objectives are fulfilled
• Conducts and attends all relevant meetings associated with job function, and completes tasks correctly and on time.
• Maintains cohesive working relationships with SMEs, management, vendors/CROs, and team to effectively interface on all projects and deliverables.
• Follows the Company’s policies and procedures and supports the Company’s Core Values.
• Travels to company site to meet with Subject Matter Experts, as needed.
• Perform other related duties and special projects, as needed
Working Conditions
• Onsite or Remote
• Bachelor’s Degree required; health care professional preferred
Education, Behavioral Competencies and Skills
• Minimum 3 years’ experience in Pharmacovigilance/Patient Safety (preferred experience in Case Processing and Risk Management).
• Minimum 3 years’ experience writing/formulating policy and procedure documentation in the biotech/pharmaceutical areas.
• Demonstrated experience performing regulatory compliance research and analysis using industry standard tools, and the ability to develop comprehensive policy and procedure documentation in accordance with regulations
• Excellent writing, editing, proofreading, and process mapping skills
• Excellent written and verbal communication skills, with the ability to communicate and interact effectively with all levels of personnel.
• Advanced software proficiency in MS Word, Excel, PowerPoint, Outlook, and other software applications, such as Visio, PleaseReview and Adobe Acrobat Pro, used in performance of job duties.
• Ability to
o perform multiple tasks and meet critical deadlines, while maintaining accuracy and quality.
o compose materials such as detailed reports, work-related manuals, publications of large scope or impact, and create presentations associated with job duties.
o understand complex problems, and to collaborate and explore alternative solutions.
o work in a fast-paced environment on large and small projects, with changing priorities.
o maintain strict confidentiality and discretion.
• Effective decision-making skills, sound judgment, and strong technical aptitude.
• Strong organization and analytical skills, with strong attention to detail.
• Strong self-starter and self-motivator, with the ability to work autonomously.
• Service and team oriented.

**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** at **.**

**_Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**

**Kelly Services is an Equal Opportunity Employer**

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect 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 connectwith 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 iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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