Principal Strategic Medical Writer - Aesthetics (Remote)

Lensa; San Francisco (CA); Remote; USD 106,000 - 203,000; Full time

Job summary

Lensa is seeking a Principal Strategic Medical Writer for AbbVie, focusing on leading the creation of critical clinical documents in the Aesthetics therapeutic area. Ideal candidates will have significant experience in the bio-pharmaceutical industry, strong writing and communication skills, and a comprehensive knowledge of medical terminology across multiple therapeutic areas.

Benefits

Comprehensive benefits package including medical/dental/vision insurance and 401(k)

Eligible for short-term and long-term incentive programs

Qualifications

• 5+ years of bio-pharmaceutical industry experience in a global pharma or life science organization.
• Extensive experience writing clinical documents following guidelines and regulations.

Responsibilities

• Lead and write clinical and regulatory device and drug documents.
• Coordinate the review, approval, and quality control of clinical documents.

Skills

Outstanding written and oral communication skills

Proficient in assimilating and analyzing complex data

Excellent writing skills

Strong organizational skills

Education

Bachelor's Degree or higher in a scientific discipline

Job description

Principal Strategic Medical Writer - Aesthetics (Remote)

Principal Strategic Medical Writer - Aesthetics (Remote)

1 day ago Be among the first 25 applicants

Lensa is the leading career site for job seekers at every stage of their career. Our client, AbbVie, is seeking professionals. Apply via Lensa today!

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .

Job Description

The Principal Strategic Medical Writer is responsible for leading and writing clinical and regulatory device and drug documents in support of company objectives for the Aesthetics therapeutic area.

Responsibilities

In Aesthetics we support drug and device documents globally. The writing team participates in writing documents from study start-up to those that support product approvals e.g. briefing books, IND, protocol, CSR, NDA sections, and regulatory response as well as CER, IDE and PMA. They also coordinate the review, approval, and quality control of other functions involved in the production of clinical and regulatory documents. The team also arranges and conducts review meetings with the team. Lastly they work closely with the team(s) on document authoring and content strategies.

Other Responsibilities Include

Communicates deliverables needed, writing process, and timelines to team members.

Holds team members accountable to agreed-upon project dates.

Contributes to project management strategies and develops ability to lead team members, driving submission objectives.

Recommends, leads, and/or participates in implementation/execution of tactical process improvements.

Develops expert knowledge of global regulations, requirements, and guidance associated with preparation of regulatory documentation.

Qualifications

Minimum Qualifications

• 5+ years of bio-pharmaceutical industry experience in a global pharma, biotech, life science, medical aesthetics, federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas.
• Bachelor's Degree or higher in a scientific discipline
• Extensive experience writing, editing clinical documents following guidelines and regulations, such as ICH guidelines, GCP, ISO, and other regulatory requirements. Familiarity with industry standards like CONSORT and PRISMA guidelines.
  
  

Other Required Skills

• Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas.
• Proficient in assimilating and analyzing complex data
• Advanced understanding of drug and/or device development, clinical research, study designs, biostatistics, regulatory requirements, and medical terminology across functional teams and multiple contributors
• Excellent writing skills, effectively communicate and influence complex scientific and medical information to various stakeholders.
• Ability to oversee multiple projects simultaneously and collaborate with cross-functional teams. Strong organizational, time management, and problem-solving skills.
  
  

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• This job is eligible to participate in our long-term incentive programs
  
  

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Salary: $106,500 - $202,500

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Marketing, Public Relations, and Writing/Editing

• Industries

  IT Services and IT Consulting

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