2018-01-14

Sr Advertising & Promotion Regulatory Content Coor
Job Opportunity at Spark Therapeutics, Inc

Posted on Jan 14

http://www.sparktx.com    215-220-9300

Location: Philadelphia, PA
Job Type: Full Time
Job ID: W4148453

The Senior Advertising & Promotion Regulatory Content Coordinator (APRCC) is responsible for editorial review of promotional and non-promotional material reviewed by the copy approval team (CAT) to ensure medical, legal, and regulatory guidance is accurately and consistently incorporated prior to distribution. In addition, s/he will proofread materials for consistency with Spark Policy, style guides, and applicable laws and regulations. The RPCE is also responsible for annotating advice from the reviewers and owners during live CAT meetings, and assisting in the submission of promotional material to FDA.

RESPONSIBILITIES:
70%         
  • Proofread  and edit promotional and non-promotional material reviewed by CAT
  • For consistency with internal/external standards, laws and regulations
  • To verify changes are correctly incorporated prior to distribution
20%         
  • Participate in live CAT meetings to capture consensus comments
  • Annotate clear, detailed, actionable guidance from regulatory, legal, and medical reviewers
10%         
  • Assist in submission of promotional materials to FDA, including required Form 2253 and voluntary requests for advisory comment

QUALIFICATIONS:
  • Detail & deadline oriented; well organized
  • Excellent proofreading and editorial skills
  • Excellent verbal and written communication skills
  • Good interpersonal skills; ability to interact with team members in various functional areas
  • Ability to understand and communicate FDA regulatory, legal, and medical guidance to carry out proofreading responsibilities

REQUIREMENTS:
  • Bachelor’s Degree in English or life sciences or related field
  • Generally has 3-5+ years of relevant work experience
  • Must have experience with proofreading or copy-editing promotional material in the pharmaceutical industry
  • Experience with Veeva PromoMats system preferred
  • Experience with/knowledge of FDA regulations of prescription drug advertising and promotion

WHO WE ARE:

Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.

















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