Associate Director, Medical Writing (Hybrid or Remote)

Company: Moderna Therapeutics
Location: Cambridge
Posted on: March 15, 2023

Job Description:

Associate Director, Medical Writing (Hybrid or Remote) page is loaded Associate Director, Medical Writing (Hybrid or Remote) Apply locations Cambridge, Massachusetts Clinical Development time type Full time posted on Posted 4 Days Ago job requisition id R11025 The Role:The Clinical Development team at Moderna is looking for an agile, self-motivated, and experienced Associate Director to serve as an integral part of the Medical Writing Team to support clinical project teams to meet their clinical document deliverables. The successful candidate will be detailed oriented, self-directed and with the ability to be flexible and manage workload to meet project timelines.Here's What You'll Do:

• Serve as the medical writing Lead contributing to a variety of clinical documents for clinical and regulatory purposes, including clinical protocols, clinical study reports, investigator brochures, and other regulatory submissions documents.
• Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents.
• Plan and coordinate timelines to ensure timely completion of clinical writing projects.
• Manage timelines and communicate with team stake holders to maintain awareness of expectations, milestones, and deliverables.
• Lead significant workstreams that involve work across departments or with external vendors
• Provide support for QC of complex clinical documentsHere's What You'll Bring to the Table:
  • Minimum of bachelor's degree or equivalent in scientific or medical discipline; Advanced degree preferred
  • Minimum of six years medical writing experience with a total of more than 10 years of pharmaceutical or biotech experience required
  • Excellent written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy
  • Experience producing high quality clinical and regulatory submission documents
  • Strong project management and organizational skills
  • Strong organizational/prioritization skills for the management of multiple concurrent projects
  • Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and experience and skill performing medical literature searches
  • Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomesAdditional Information:
    • Hybrid work arrangement available for those local to our Cambridge, MA headquarters or fully remote within the US with ability to travel onsite as necessary
    • Multiple vacancies availableModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
      • Highly competitive and inclusive medical, dental and vision coverage options
      • Flexible Spending Accounts for medical expenses and dependent care expenses
      • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
      • Family care benefits, including subsidized back-up care options and on-demand tutoring
      • Free premium access to fitness, nutrition, and mindfulness classes -
      • Exclusive preferred pricing on Peloton fitness equipment
      • Adoption and family-planning benefits
      • Dedicated care coordination support for our LGBTQ+ community
      • Generous paid time off, including:
        --- Vacation, sick time and holidays
        --- Volunteer time to participate within your community
        --- D iscretionary year-end shutdown
        --- Paid sabbatical after 5 years; every 3 years thereafter
      • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
      • 401k match and Financial Planning tools
      • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
      • Complimentary concierge service including home services research, travel booking, and entertainment requests
      • Free parking or subsidized commuter passes
      • Location-specific perks and extras! Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible . Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law. About ModernaIn over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com .Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.- Similar Jobs (1) Associate Director, Medical Writing (Hybrid or Remote) locations 2 Locations time type Full time posted on Posted 4 Days Ago About Us Our Mission and VisionAt Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.Third Party Staffing AgenciesM oderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation NoticeModerna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process.Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.Return Home

Keywords: Moderna Therapeutics, Cambridge , Associate Director, Medical Writing (Hybrid or Remote), Executive , Cambridge, Massachusetts