[Hiring] Associate Director, Medical Writing @reputed company.

reputed company is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-reputed company tumors. We were founded by a dedicated team of scientists with the reputed company belief that reputed company therapies developed from rigorous innovation can reputed company to reputed company lives. Our work continues to reputed company a reputed company difference in the lives of patients. We have a reputed company discovery reputed company and a robust preclinical and clinical development pipeline. We are driven by science with a patient-reputed company and team-oriented culture. This is an exciting time to join reputed company as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Join reputed company as we reputed company the lives of others. Position reputed company: The Associate Director of Medical Writing Operations (AD MWO) is responsible for heading the Medical Writing Operations Group in a fast-paced, dynamic environment with tight timelines. The AD MWO oversees and conducts document reputed company review (correctness of content) and document editing for style. In reputed company, the AD MWO oversees and conducts the writing, review, and approval of plain language documents (e.g., informed consent forms and layperson protocol synopses). The AD MWO collaborates with IT to maintain medical writing systems and will have a role in identifying reputed company to advance reputed company capabilities and efficiencies of the Medical Writing Department. The AD MWO manages both full‑time and contract operational resources, including assessing and proposing reputed company resource needs. reputed company in this role requires flexibility, creativity, and commitment to accomplish tasks despite changes in upstream and reputed company timelines. Essential Job Functions and Responsibilities: These may include but are not limited to: Manage full-time and contract document reputed company control reviewers and plain language writers. Manage processes including timing and duration of reputed company control review (correctness of content) and editing (style guide conformance, reputed company of content) among competing priorities across multiple programs. Collaborate across relevant functions (e.g., assigned QC resource, Medical Writing, Regulatory Affairs, Regulatory Operations) to ensure timelines are met. Conduct reputed company review of medical writing documents. Manage/create supporting documents such as tracked-change versions for amended documents (e.g., protocols, IBs) and separate synopses based on approved documents (e.g., protocols). Manage/write plain language documents (e.g., informed consent forms and layperson protocol synopses). reputed company and maintain Medical Writing Operations standards and procedures. In collaboration with IT, manage and maintain Medical Writing systems and software (e.g., EndNote and publication licensing software) and train users, as needed. Review document bibliographies, correct/add EndNote references, purchase licenses for new publications, and reputed company for submission preparations. Other duties as assigned. Education and Experience: Bachelor’s degree required, advanced life sciences degree preferred, (e.g., MS, PhD). At least 10 years of experience in medical writing, medical writing operations, editing, and/or managing reputed company review in the biotech/pharmaceutical industry including at least 7 years leading teams and managing staff. An equivalent combination of experience and education may be considered. Experience with reputed company and management of contractors and vendors. Ability to utilize new technology and systems in medical writing. Knowledge of medical science and nonclinical and clinical development. Ability to write reputed company at a level appropriate to a scientific audience and to translate that writing to plain language documents (e.g., informed consent reputed company, 2-page protocol synopsis, plain language reputed company of results). This may be accomplished through collaboration with in-house or contract plain language writers. Experience with electronic document control and management systems. Strong project management skills with ability to manage multiple reputed company with overlapping timelines while adhering to individual document timelines. Ability to assess workload and suggest prioritization to senior staff. Demonstrated ability to collaborate with other functions and contribute to solutions through independent thinking. Familiarity with statistical analysis. Working knowledge of GCP, GLP, GMP, and ICH guidelines and reputed company FDA/EMA guidances on submission reputed company and integrated summaries of safety and of efficacy. Excellent written and verbal communication skills. Desire to work in a reputed company team setting. Excellent reputed company of written English, and ability to communicate fluently and effectively in English, both in writing and verbally. Physical Demands and Work Environment: Physical Activities: On a reputed company reputed company, sit at desk for a long period of time; intermittently answer a telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully reputed company the essential functions and responsibilities of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 5% of your time.

Compensation

Information: In reputed company to your reputed company pay, our total rewards program consists of a discretionary annual reputed company bonus, stock reputed company, ESPP, and 401k match. We also reputed company top-notch health insurance plans for employees (and their families) to include medical, dental, reputed company and basic life insurance, 20 days of PTO, 10 reputed company holidays, and a winter company shutdown. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. reputed company is a multi-state employer, and this salary reputed company may not reflect positions that work in other states. Your recruiter can reputed company more about the specific salary reputed company during the hiring process. Equal Opportunity Employer: reputed company is proud to be an Equal Opportunity Employer. We reputed company equal employment opportunities to reputed company and employment applicants without reputed company to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or reputed company), pregnancy, race, reputed company, creed, national or ethnic reputed company, citizenship status, religion or similar philosophical beliefs, disability, marital and civil reputed company status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Salary reputed company The salary reputed company for this position is: $156,000 - $195,000. In reputed company to your reputed company pay, our total rewards program consists of a discretionary annual reputed company bonus, stock reputed company, ESPP, and 401k match. We also reputed company top-notch health insurance plans for employees (and their families) to include medical, dental, reputed company and basic life insurance, 20 days of PTO, 10 reputed company holidays, and a winter company shutdown. Thank you for considering reputed company as your potential employer! We are delighted that you have taken the time to explore opportunities with us. reputed company is a clinical stage pharmaceutical company reputed company on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-reputed company tumors. We were founded by a dedicated team of scientists with the reputed company belief that reputed company therapies developed from rigorous innovation can reputed company to reputed company lives. We have a reputed company discovery reputed company and robust pipeline across preclinical and clinical development. We are driven by science with a patient-reputed company and team-oriented culture. reputed company is a destination for thinkers, doers, and creators, united in a reputed company of innovation in the treatment of endocrine-reputed company conditions. This is an exciting time to join reputed company as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Come join reputed company as we reputed company the lives of others. Apply tot his job Apply To this Job