Principal Strategic Medical Writer - Aesthetics (Remote)

Initial Therapeutics, Inc.; Boston (MA); Remote; USD 100,000 - 150,000; Full time

Job summary

A leading company in the biopharmaceutical sector is seeking a Principal Strategic Medical Writer to lead the writing of clinical and regulatory documents in the Aesthetics therapeutic area. The role involves collaborating with cross-functional teams, ensuring compliance with global regulations, and managing multiple projects effectively. Ideal candidates will have extensive experience in the biopharmaceutical industry, strong communication skills, and a proven ability to produce high-quality documentation.

Benefits

Comprehensive benefits package including medical, dental, and vision insurance

Paid time off including vacation, holidays, and sick leave

401(k) plan for eligible employees

Participation in short-term and long-term incentive programs

Qualifications

• 5+ years of bio-pharmaceutical industry experience.
• Extensive experience writing clinical documents following guidelines.
• Familiarity with industry standards like CONSORT and PRISMA.

Responsibilities

• Lead and write clinical and regulatory documents.
• Coordinate review and approval of clinical documents.
• Communicate deliverables and timelines to team members.

Skills

Outstanding written and oral communication skills

Proficient in assimilating and analyzing complex data

Excellent writing skills

Strong organizational skills

Problem-solving skills

Education

Bachelor's Degree or higher in a scientific discipline

Job description

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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

The Principal Strategic Medical Writer is responsiblefor 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 orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable 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, visithttps://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